The purpose of this study is to test the safety and effectiveness of using brodalumab in patients who develop side effects from cancer immune therapy. Immune-related side effects are due to activation of the immune system in patients who previously received immunotherapy and the goal of this study is to help better control these side effects. Brodalumab is often used to treat patients with autoimmune diseases (diseases where the immune system is activated against normal organs) and safe doses and treatment schedules have been determined in these patients. Immune-related side effects appear to closely mirror these autoimmune conditions. Brodalumab has not been approved by the United States Food and Drug Administration (FDA) for use in immunotherapy side effects but it has been approved for treatment of autoimmune conditions.

Start Date01 Nov 2024

Sponsor / Collaborator

Columbia University

[+1]

ISRCTN15271834

/ RecruitingPhase 2IIT

A Single Arm pilot study of BRodalumab in the treatment of Primary Sclerosing Cholangitis

Start Date02 Feb 2024

Sponsor / Collaborator

Norfolk & Norwich University Hospitals NHS Foundation Trust

NCT04305327

/ TerminatedPhase 3

A Phase 3, Randomised, Double-blind, Multi-centre Trial to Evaluate the Efficacy, Safety, and Tolerability of Brodalumab Treatment Compared to Placebo and Ustekinumab in Adolescent Subjects With Moderate-to-severe Plaque Psoriasis

The study will investigate the efficacy and safety compared to placebo and the safety compared to ustekinumab of brodalumab in adolescents with moderate to severe plaque psoriasis. The study will also investigate if brodalumab affects development of vaccination-induced immune responses.
The study will run over 62-64 weeks (including screening, treatment, and safety follow-up) for each participant, but with the primary endpoint measured at Week 12.

Start Date07 Dec 2022

Sponsor / Collaborator

Leo Pharma, Inc.

100 Clinical Results associated with Brodalumab

100 Translational Medicine associated with Brodalumab

100 Patents (Medical) associated with Brodalumab

562

Literatures (Medical) associated with Brodalumab

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Effectiveness, speed of action and safety of brodalumab in elderly psoriasis patients: a multicenter real-world study – IL PSO (Italian Landscape Psoriasis)

Article

Author: Baggini, G. ; De Col, E. ; Brunasso, A. M. G. ; Legori, A. ; Cona, F. ; Campione, E. ; Zichichi, L. ; Orsini, D. ; Dattola, A. ; Dal Bello, Giacomo ; Pagnanelli, G. ; Balestri, R. ; Vaira, F. ; Carriero, M. ; Narcisi, A. ; Arancio, L. M. H. ; Di Tano, A. ; Rubatto, M. ; Lazzaro Danzuso, Giovanni Carlo ; Diotallevi, F. ; Musumeci, M. L. ; Donnarumma, M. ; Calianno, G. ; Strippoli, D. ; Caldarola, Giacomo ; Licciardello, M. ; Musumeci, A. ; Rizzo, D. ; Cagni, A. E. ; Moretta, G. ; Fargnoli, M. C. ; Travaglini, M. ; Galluzzo, M. ; Fiorella, C. S. ; Costanzo, A. ; Sarno, Oriele ; Malagoli, P. ; Burlando, M. ; Guarneri, C. ; Graceffa, D. ; Carugno, A. ; Esposito, M. ; Campanati, A. ; Muracchioli, A. ; Carpentieri, A. ; Provenzano, E. ; Panasiti, V. ; Mola, Federica ; Romita, P. ; Pella, P. ; Cozzani, E. ; Graziola, F. ; Bianchi, L.

01 Mar 2025·JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY

Persistence of advanced systemic pharmacological treatment of moderate‐to‐severe psoriasis among bio‐naïve patients—A retrospective register‐based cohort study in Finland and Sweden

Article

Author: Passey, A. ; Wennerström, C. ; Johnsson, I. ; Hoti, F. ; Mälkönen, T. ; Katus, U. ; Hermanrud, C. ; Westerlund, A. ; Sveide, I. ; Hassan, F. ; Polesie, S. ; Tskhvarashvili, G. ; Saarelainen, L. ; Aher, K. ; Lee, J. ; Nissinen, R.

Abstract:

Background:

Plaque psoriasis (PsO) requires long‐term treatment for symptom control and remission; thus, a long‐term pharmacological intervention is necessary. Treatment persistence reflects long‐term therapeutic effectiveness and tolerance.

Objectives:

This study investigates drug persistence and compares treatment discontinuation rates across biologic agents and apremilast used by PsO patients in Finland and Sweden.

Methods:

This retrospective register‐based cohort study included bio‐naïve patients (≥18 years) with moderate‐to‐severe PsO, who initiated treatment with abatacept, adalimumab, brodalumab, certolizumab pegol, etanercept, golimumab, guselkumab, ixekizumab, risankizumab, secukinumab, tildrakizumab, ustekinumab or apremilast during 2008–2020 in Finland or Sweden. The main analysis evaluated persistence (based on duration of continuous treatment) and compared rates of treatment discontinuation using guselkumab as reference drug, during 2018–2020 in Finland. Treatment discontinuation was assessed by survival analysis of the time to first drug discontinuation, including switching to other study drugs. Due to limited sample size (n < 20), certain biologics (abatacept, brodalumab, certolizumab pegol, etanercept, golimumab, risankizumab and tildrakizumab) were excluded from the persistence analysis.

Results:

In Finland, 709 patients fulfilled the inclusion criteria during 2018–2020 for the main analysis. The highest persistence was observed for guselkumab and ustekinumab with 90 and 85% of treated patients, respectively, continuing treatment for ≥1 year. Comparable results were observed in the expanded cohort analysis (index starting in 2008; 2745 bio‐naïve patients in Finland and 10,970 in Sweden). Furthermore, patients treated with guselkumab in Finland showed lower treatment discontinuation rates compared to other study drugs.

Conclusion:

Guselkumab and ustekinumab demonstrated high persistence as measured by continued treatment for at least 1 year. Furthermore, these treatments demonstrated lower rates of discontinuation compared to other study drugs included in the analysis. Understanding the balance between efficacy and feasibility in treatment decisions is crucial, as feasibility may impact persistency outcomes and potentially increase persistency rates.

01 Mar 2025·Dermatology and Therapy

PSO-TARGET: a New Tool to Identify the Therapeutic Expectations of Psoriasis Patients Treated with Biologics

Article

Author: Ghislain, Pierre-Dominique ; Baudier, Emilie ; Schepkens, Corentin ; Boyé, Thierry ; Moulin, Pierre ; Reguiai, Ziad ; Sintès, Maxime

INTRODUCTION:

The effectiveness of psoriasis treatment is assessed by standardized tools such as the Dermatology life Quality Index (DLQI) and Psoriasis Area Severity Index (PASI). However, discrepancies between patients and physicians in terms of treatment success and goals, along with the growing importance of shared decision-making in healthcare, highlight the need for tools specifically designed for psoriasis. Such tools can enhance communication between patients and physicians, encouraging shared decision-making and improving the assessment of patient treatment expectations.

METHODS:

Comparison of the new PSO-TARGET grid, which consists of 12 therapeutic goals evenly distributed across 4 major components commonly used in quality of life (QoL) studies for chronic diseases, with DLQI as a standard tool, was utilized.

RESULTS:

A total of 143 adult patients with moderate-to-severe psoriasis and treated with brodalumab were included. On the basis of a blind assessment, dermatologists were not able to identify the patients' chosen PSO-TARGET goal in more than 50% of cases. The comparison after 12/16 weeks of treatment revealed some discrepancies between the two QoL tools. Compared with the rest of the population, the patients who achieved their PSO-TARGET goal, but still reported a DLQI > 1, had higher baseline PASI scores (18.6 versus 14.8; p = 0.067), higher DLQI scores (14.1 versus 10.1; p = 0.004), and a higher number of hard-to-treat locations (median of 2 versus 1; p = 0.004). In addition, patients who had not reached their PSO-TARGET goal but reported a DLQI ≤ 1, all had psoriasis on the scalp at the baseline and were generally younger (median of 31 versus 52 years, p = 0.001).

CONCLUSIONS:

This study highlights the importance of considering patient characteristics of those with psoriasis and perspectives when evaluating treatment outcomes. Using shared decision-making tools such as the PSO-TARGET grid can improve communication and understanding between dermatologists and patients.

TRIAL REGISTRATION:

ClinicalTrials.gov identifier, NCT04765332.

News (Medical) associated with Brodalumab

25 Sep 2024

·www.businesswire.com

LEO Pharma Unveils Most Extensive EADV Program To Date with 5 Late Breaking Abstracts and 23 Posters Sharing Clinical and Real-World Data

BALLERUP, Denmark--( BUSINESS WIRE )-- NOT FOR UK USE – NOT INTENDED FOR UK MEDIA LEO Pharma A/S, a global leader in medical dermatology, will present new clinical and real-world data from across its portfolio of products at the upcoming 33 rd European Academy of Dermatology and Venereology (EADV) Congress. The event will be held from the 25 th to the 28 th of September in Amsterdam, Netherlands, where LEO Pharma will present 5 coveted late-breaking presentations in addition to 23 scientific posters for a range of skin conditions, forming the largest collection of data LEO Pharma has ever shared at the EADV congress. 1-28 “ It is extraordinary to witness the breadth and variety of LEO Pharma’s scientific contribution at this year’s EADV Congress. It is a record-breaking presence for us – and we cannot wait to share this ground-breaking data with the medical dermatology community ,” said Christophe Bourdon, CEO of LEO Pharma. The first late-breaking presentation for Anzupgo ® (delgocitinib) cream will provide data from the 24-week DELTA FORCE trial that compared the efficacy and safety of topical delgocitinib cream with oral alitretinoin capsules in adults with severe CHE. 1 An additional late-breaking oral presentation will provide data from the matching-adjusted indirect comparison (MAIC) of the efficacy of delgocitinib and dupilumab in the treatment of moderate to severe atopic hand eczema. 25 The third delgocitinib cream late-breaking presentation will provide information on biomarker and efficacy data from the randomized vehicle-controlled clinical trial with delgocitinib cream in patients with frontal fibrosing alopecia. 26 A late-breaking presentation will also be presented for Adtralza/Adbry, highlighting the interim real-world effectiveness results of tralokinumab in adult patients with head and neck atopic dermatitis after up to 9 months of treatment in the TRACE real world evidence (RWE) study. 27 Finally, a late-breaking presentation for temtokibart will also be presented, comparing clinical and molecular responses in the targeting of IL-22RA1 with temtokibart vs dupilumab in patients with moderate to severe atopic dermatitis. 28 " The 2024 EADV Congress marks a pivotal moment for LEO Pharma as we unveil a wealth of new data," said Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma. " Our presentations at EADV showcase our most comprehensive research portfolio to date, underscoring our unwavering commitment to developing innovative dermatological therapies and helping to bring new hope to patients grappling with challenging skin conditions." The company’s full roster at the 2024 EADV Congress, encompassing new research, encore abstracts, and 3 symposiums, 1-28 includes: Anzupgo ® (delgocitinib) cream DELTA FORCE trial: A 24-week head-to-head phase 3 trial comparing the efficacy and safety of topical delgocitinib cream with oral alitretinoin capsules in adults with severe chronic hand eczema Author: Ana Maria Giménez-Arnau Presentation ID: D1T01.1F LB presentation: Wednesday, 25 Sep, 15:30 - 15:45 Location: Auditorium Matching-adjusted indirect comparison of the efficacy of delgocitinib and dupilumab in the treatment of moderate to severe atopic hand eczema Author: David Cohen Presentation ID: D3T01.4B LB presentation: Friday, 27 Sep, 16:15 - 16:30 Location: Auditorium Randomized vehicle-controlled clinical trial with the topical JAK inhibitor delgocitinib in patients with frontal fibrosing alopecia demonstrates biomarker and clinical efficacy Author: Maryanne Makredes Senna Presentation ID: D3T01.4F LB presentation: Friday, 27 Sep, 17:15 - 17:30 Location: Auditorium Treatment response of delgocitinib cream according to Chronic Hand Eczema (CHE) subtypes in adults with moderate to severe CHE: results from the Phase 3 DELTA 1, DELTA 2, and DELTA 3 trials Author: Robert Bissonnette Presentation ID: FC07.04 Oral presentation: Friday, 27 Sep, 14:45 - 14:55 Location: G104-G105 Topical pan-JAK inhibition with delgocitinib restores the molecular signature of lesional skin in patients with Chronic Hand Eczema Author: Sonja Molin Poster ID: P0572 ePoster presentation Health-related quality of life in people with Chronic Hand Eczema - Findings from the multi-national CHECK study Author: Anthony Bewley Poster ID: P3443 ePoster presentation Clinical trial exit interviews in patients with moderate to severe Chronic Hand Eczema: perspectives on disease burden and its impact on quality of life from participants in the phase 3 DELTA 1 trial Author: Padma Mohandas Poster ID: P0532 ePoster presentation Patient characteristics and comorbidities in moderate-to-severe CHE: Results from the RWEAL study Author: Maria Concetta Fargnoli Poster ID: P2559 ePoster presentation The multifactorial and heterogenous nature of Chronic Hand Eczema in clinical practice: Results from the RWEAL study Author: Maria Concetta Fargnoli Poster ID: P0608 ePoster presentation Delgocitinib cream reduces itch and pain in adults with moderate to severe Chronic Hand Eczema: pooled analyses of the Phase 3 DELTA 1 and 2 trials Author: Andrea Bauer Poster ID: P0564 ePoster presentation Efficacy and safety of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema: pooled results of the Phase 3 DELTA 1 and 2 trials Author: Marie Louise Schuttelaar Poster ID: P0569 ePoster presentation Systemic exposure and safety profile of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema in the Phase 3 DELTA 2 trial Author: Melinda Gooderham Poster ID: P0581 ePoster presentation Long-term safety and efficacy of delgocitinib cream for up to 36 weeks in adults with Chronic Hand Eczema: results of the Phase 3 open-label extension DELTA 3 trial Author: Sonja Molin Poster ID: P0565 ePoster presentation Association and impact of Chronic Hand Eczema on occupational and household/leisure activities– results from the multinational CHECK study Author: Marie Noelle Crepy Poster ID: P1076 ePoster presentation Prevalence of Chronic Hand Eczema in adults: A cross-sectional multi-national study of over 60,000 respondents in the general population Author: Christian Apfelbacher Poster ID: P1901 ePoster presentation Treatment patterns in moderate to severe Chronic Hand Eczema - Results from the multinational RWEAL medical chart review Author: Ana Maria Giménez-Arnau Poster ID: P3568 ePoster presentation Self-reported disease severity and treatment of Chronic Hand Eczema from the CHECK study - A multinational study in six countries Author: Sonja Molin Poster ID: P3526 ePoster presentation Adtralza ® (tralokinumab)/Adbry ® (tralokinumab-ldrm) Real-world effectiveness of tralokinumab in adults with atopic dermatitis: Interim data on improvements in patients with head and neck atopic dermatitis after up to 9 months of treatment in the TRACE study Author: April Armstrong Presentation ID: D3T01.3C LB presentation: Friday, 27 Sep, 14:45 - 15:00 Location: Auditorium Real-world effectiveness of tralokinumab in adults with atopic dermatitis: Interim data on improvements in physician-assessed disease severity after up to 9 months of follow-up in the TRACE study Author: Elena Pezzolo Poster ID: P0689 ePoster presentation Real-world effectiveness of tralokinumab in adults with atopic dermatitis: Interim data on improvements in patient-reported outcomes after up to 9 months of follow-up in the TRACE study Author: Antonio Costanzo Poster ID: P0690 ePoster presentation Long-term safety and efficacy of tralokinumab in patients 65 years or older with moderate-to-severe atopic dermatitis Author: Andrew Blauvelt Poster ID: P0479 ePoster presentation Improvement of the head and neck regions with continuous tralokinumab treatment for up to 4 years in adults with moderate-to-severe atopic dermatitis Author: Raj Chovatiya Poster ID: P0595 ePoster presentation Tralokinumab formulated as a pre-filled pen was efficacious and well-tolerated in adults and adolescents with moderate-to-severe atopic dermatitis Author: Jennifer Soung Poster ID: P0574 ePoster presentation Stability of long-term therapeutic responses to tralokinumab in adults with moderate-to-severe atopic dermatitis Author: Andrew Blauvelt Poster ID: P0596 ePoster presentation Kyntheum ® (brodalumab) Observational study to assess the real-life descriptive effectiveness in patients with moderate to severe plaque psoriasis treated with Brodalumab stratified by patients with BMI>30 and patients with BMI ≤ 30. The BROACTIVE Study. 2 years - results. Author: Juan Escalas Poster ID: P3205 ePoster presentation Long-term management outcome assessment of adult patients with moderate-to-severe plaque psoriasis treated with brodalumab in Greece: The ReSOLVE study. Author: Pantelis Panagakis Poster ID: P3102 ePoster presentation Temtokibart Targeting IL-22RA1 with temtokibart in patients with moderate to severe atopic dermatitis induces fast clinical and molecular responses, distinct from dupilumab Author: Christine Bangert Presentation ID: D2T01.3A LB presentation: Thursday, 26 Sep, 14:15 - 14:30 Location: Auditorium Individual responses to IL-22RA1 inhibition in Asian patients with moderate-to-severe atopic dermatitis in Phase 1 and 2a clinical trials Author: Diamant Thaçi Poster ID: P0691 ePoster presentation In addition to the abstracts and poster presentations, LEO Pharma will also present 3 symposiums at the meeting: A New Era in Atopic Dermatitis Speakers: Prof. Melinda Gooderham, Prof. April Armstrong and Prof. Marjolein de Bruin-Weller 17:45–19:15 CEST on Thursday the 26th of September in Room 7.1, RAI Amsterdam Plaque psoriasis and obesity — a double burden for patients? Speakers: Prof. Dr med. Khusru Asadullah and Dr Matteo Megna 11:15-12:00 CEST on Thursday the 26th of September in Amtrium 1, Hall 4, RAI Amsterdam Chronic Hand Eczema Breaking the Silent Conversation Speakers: Prof. Swen Malte John, Prof. April Armstrong, Dr Marie-Louise Schuttelaar 13:00-14:00 CEST on Friday the 27 th of September in Room 7.3, RAI Amsterdam. About Chronic Hand Eczema Chronic hand eczema (CHE) is defined as hand eczema (HE) that lasts for more than three months or relapses twice or more within a year. 29,30 CHE is one the most common skin disorder of the hands with a prevalence rate of approximately 4.7%. 31 In a substantial number of patients, HE can develop into a chronic condition. 32 CHE is a fluctuating disorder characterized by itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on hands and wrists. 33 CHE has been shown to cause psychological and functional burdens that impact patient quality of life, 34 with approximately 70% of individuals who live with severe CHE admitting to problems in performing everyday activities, and suffering disruption in their daily life due to the condition. 35 Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE. 36 About Atopic Dermatitis Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions. 37 Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation. 38 Type 2 cytokines, including IL-13, play an important role in the key aspects of atopic dermatitis pathophysiology. 37,38 Excessive IL-22 production is also known to contribute to the pathogenesis of AD. 39 About Psoriasis Psoriasis is a chronic, systemic inflammatory disease that primarily affects the skin in 125 million people worldwide. 40,41 Psoriasis is the result of skin barrier cell proliferation and the activation of cytokines (a family of proteins involved in immune responses) that cause inflammation. 42 About 80% to 90% of patients are affected by plaque psoriasis, the most common clinical form of psoriasis. 43 The symptoms of plaque psoriasis are itchy or painful raised scaly and inflamed plaques. Plaques may appear anywhere on the body, but often appear on the scalp, knees, elbows and torso. 43 About Anzupgo ® (delgocitinib) cream Anzupgo ® (delgocitinib) cream 20 mg/g is a topical pan-Janus kinase (JAK) inhibitor for the treatment of moderate to severe CHE. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE. 44 The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome. 45 Anzupgo is currently approved in the European Union for the treatment of moderate to severe chronic hand eczema (CHE) in adults for whom topical corticosteroids are inadequate or inappropriate. In 2014, LEO Pharma A/S and Japan Tobacco Inc. (JT) entered into a license agreement in which LEO Pharma gained exclusive rights to develop and commercialize delgocitinib cream for topical use in dermatological indications worldwide, excluding Japan, where JT retains rights. About Adtralza ® (tralokinumab) / Adbry ® (tralokinumab-ldrm) Adtralza ® (tralokinumab), which is marketed under the tradename Adbry ® in the U.S., is a high-affinity fully human monoclonal antibody developed to bind to and inhibit the interleukin IL-13 cytokine, which plays a role in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms. 38,46 Adtralza ® specifically binds to the IL-13 cytokine, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2). 47 Adtralza ® is approved for the treatment of moderate to severe AD in adult and adolescent patients 12 years and older in the European Union, Canada, Great Britain, the United Arab Emirates, and South Korea. Adtralza ® is approved for use in adults with moderate to severe AD in the U.S., Switzerland, Saudi Arabia, and Japan. About Kyntheum ® (brodalumab) Kyntheum ® (brodalumab) is a recombinant fully human monoclonal immunoglobulin IgG2 antibody that binds with high affinity to human IL-17RA and blocks the biological activities of the pro-inflammatory cytokines IL-17A, IL-17F, IL-17A/F heterodimer, IL-17C and IL-17E (also known as IL-25), resulting in inhibition of the inflammation and clinical symptoms associated with psoriasis. IL-17RA is a protein expressed on the cell surface and is a required component of receptor complexes utilized by multiple IL-17 family cytokines. IL-17 family cytokine levels have been reported to be increased in psoriasis. IL-17A, IL-17F and IL-17A/F heterodimer have pleiotropic activities including the induction of pro-inflammatory mediators such as IL-6, GROα, and G-CSF from epithelial cells, endothelial cells and fibroblasts that promote tissue inflammation. IL-17C has been shown to induce similar responses as IL-17A and IL-17F in keratinocytes. Blocking IL-17RA inhibits IL-17 cytokine-induced responses resulting in normalization of inflammation in the skin. 48 Kyntheum ® is indicated in the European Union, Great Britain, the United Arab Emirates, and Brazil for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy. About temtokibart Temtokibart (LEO 138559) is an investigational monoclonal antibody that targets the IL-22RA1 receptor subunit, currently in Phase 2 development for the potential treatment of moderate to severe atopic dermatitis. 49 It blocks the IL-22RA1 subunit and thereby inhibits the effects of the IL-22 cytokine, and potentially also to some extent the effects of IL-20 and IL-24. 49 Temtokibart does not bind to the IL-22 cytokine itself. 49 LEO Pharma has obtained a worldwide exclusive license to develop and commercialize temtokibart from argenx. About LEO Pharma LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities. LEO Pharma is headquartered in Denmark with a global team of 4,200 people, serving millions of patients across the world. In 2023, the company generated net sales of DKK 11.4 billion. References Giménez-Arnau AM, Pinter A, Sondermann W et al. DELTA FORCE trial: A 24-week head-to-head phase 3 trial comparing the efficacy and safety of topical delgocitinib cream with oral alitretinoin capsules in adults with severe chronic hand eczema. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. Oral Presentation. D1T01.1F. Bisonnette R, Schliemann S, Gooderham M, et al. Treatment response of delgocitinib cream according to Chronic Hand Eczema (CHE) subtypes in adults with moderate to severe CHE: results from the Phase 3 DELTA 1, DELTA 2, and DELTA 3 trials. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. Oral Presentation. FC07.04 Giménez-Arnau AM, Bewley A, Molin S, et al. Patient characteristics and comorbidities in moderate-to-severe CHE: Results from the RWEAL study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P2559 Fargnoli MN, Molin S, Bewley A, et al. The multifactorial and heterogenous nature of Chronic Hand Eczema in clinical practice: Results from the RWEAL study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0608. Worm M, Jiang L, Litman T, et al. Topical pan-JAK inhibition with delgocitinib restores the molecular signature of lesional skin in patients with Chronic Hand. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. Oral Presentation. P0572. Bewley A, Molin S, Crepy MN, et al. Health-related quality of life in people with Chronic Hand Eczema - Findings from the multi-national CHECK study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P3443. Mohandas P, Devani AR, Baranowski K, et al. Clinical trial exit interviews in patients with moderate to severe Chronic Hand Eczema: perspectives on disease burden and its impact on quality of life from participants in the phase 3 DELTA 1 trial. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0532. Pezzolo E, Cork M, Beecker J, et al. Real-world effectiveness of tralokinumab in adults with atopic dermatitis: Interim data on improvements in physician-assessed disease severity after up to 9 months of follow-up in the TRACE study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0689. Costanzo A, Becherel PA, Serra E, et al. Real-world effectiveness of tralokinumab in adults with atopic dermatitis: Interim data on improvements in patient-reported outcomes after up to 9 months of follow-up in the TRACE study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0690. Escalas J, Armesto S, Abalde T, et al. Observational study to assess the real-life descriptive effectiveness in patients with moderate to severe plaque psoriasis treated with Brodalumab stratified by patients with BMI>30 and patients with BMI ≤ 30. The BROACTIVE Study. 2 years - results. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P3205. Panagakis P, Chasapi V, Kalapothakou K, et al. Long-term management outcome assessment of adult patients with moderate-to-severe plaque psoriasis treated with brodalumab in Greece: The ReSOLVE study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P3102. Thaçi D, Bangert C, Laquer V, et al. Individual responses to IL-22RA1 inhibition in Asian patients with moderate-to-severe atopic dermatitis in Phase 1 and 2a clinical trials. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0691. Blauvelt A, Merola J, Carrascosa JM, et al. Long-term safety and efficacy of tralokinumab in patients 65 years or older with moderate-to-severe atopic dermatitis. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0479. Bauer A, Schuttelaar ML, Baranowski K, et al. Delgocitinib cream reduces itch and pain in adults with moderate to severe Chronic Hand Eczema: pooled analyses of the Phase 3 DELTA 1 and 2 trials. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0564. Schuttelaar ML, Bisonnette R, Worm M, et al. Efficacy and of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema: pooled results of the Phase 3 DELTA 1 and 2 trials. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0569. Gooderham M, Thaçi D, Damgaard T, et al. Systemic exposure and safety profile of delgocitinib cream in adults with moderate to severe Chronic Hand Eczema in the Phase 3 DELTA 2 trial. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0581. Molin S, Gooderham M, Bisonnette R, et al. Long-term safety and efficacy of delgocitinib cream for up to 36 weeks in adults with Chronic Hand Eczema: results of the Phase 3 open-label extension DELTA 3 trial. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0565. Crepy MN, Molin S, Giménez-Arnau AM, et al. Association and impact of Chronic Hand Eczema on occupational and household/leisure activities– results from the multinational CHECK study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P1076. Apfelbacher C, Bewley A, Molin S, et al. Prevalence of Chronic Hand Eczema in adults: A cross-sectional multi-national study of over 60,000 respondents in the general population. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P1901. Giménez-Arnau AM, Bewley A, Apfelbacher C et al. Treatment patterns in moderate to severe Chronic Hand Eczema - Results from the multinational RWEAL medical chart review. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P3568. Molin S, Fargnoli MN, Crepy MN, et al. Self-reported disease severity and treatment of Chronic Hand Eczema from the CHECK study - A multinational study in six countries. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P3526 . Chovatiya R, Wollenberg A, Ribero S, et al. Improvement of the head and neck regions with continuous tralokinumab treatment for up to 4 years in adults with moderate-to-severe atopic dermatitis. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0595. Soung J, Laquer V, Zirwas M, et al. Tralokinumab formulated as a pre-filled pen was efficacious and well-tolerated in adults and adolescents with moderate-to-severe atopic dermatitis. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0574. Blauvelt A, Hong HC, Peris K, et al. Stability of long-term therapeutic responses to tralokinumab in adults with moderate-to-severe atopic dermatitis. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. EPoster Presentation. P0596. Cohen D, Bewley A, Wollenberg A, et al. Matching-adjusted indirect comparison of the efficacy of delgocitinib and dupilumab in the treatment of moderate to severe atopic hand eczema. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. Oral Presentation.D3T01.4B. Senna MM, Soerensen OE, Nielsen AB et al. Randomized vehicle-controlled clinical trial with the topical JAK inhibitor delgocitinib in patients with frontal fibrosing alopecia demonstrates biomarker and clinical efficacy. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. Oral Presentation. D3T01.4F. Armstrong A, Ameen A, Bagel J et al. Real-world effectiveness of tralokinumab in adults with atopic dermatitis: Interim data on improvements in patients with head and neck atopic dermatitis after up to 9 months of treatment in the TRACE study. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. Oral Presentation. D3T01.3C Bangert C, Berdyshev E, Alkon N et al. Targeting IL-22RA1 with temtokibart in patients with moderate to severe atopic dermatitis induces fast clinical and molecular responses, distinct from dupilumab. Presented at the European Academy of Dermatology and Venereology (EADV) Congress 2024. Amsterdam, Netherlands. 25-28 September. Oral Presentation. D2T01.3A. Lynde C, Guenther L, Diepgen TL, et al. Canadian hand dermatitis management guidelines. J Cutan Med Surg. 2010;14(6):267-284. Erratum in: J Cutan Med Surg. 2011 Nov-Dec;15(6):360. Diepgen TL, et al. Guidelines for diagnosis, prevention and treatment of hand eczema. J Dtsch Dermatol Ges. 2015 Jan;13(1):e1–22. Apfelbacher C, Bewley A, Molin S, et al. Prevalence of Chronic Hand Eczema in adults: A cross-sectional multi-national study of 60,000 respondents in the general population. Presented at the 2024 European Society of Contact Dermatitis (ESCD) congress; September 04-07 2024; Dresden, Germany. Poster presentation #3 Bissonnette R, et al. Redefining treatment options in chronic hand eczema (CHE). JEADV . 2010;24;1–20. Thyssen JP, Silverberg JI, Guttman-Yassky E. Chronic hand eczema understanding has ramifications on clinical management. J Eur Acad Dermatol Venereol. 2020;34(8):e429-e430. Grant L, Seiding Larsen L, Burrows K, et al. Development of a Conceptual Model of Chronic Hand Eczema (CHE) Based on Qualitative Interviews with Patients and Expert Dermatologists. Adv Ther. 2020;37(2):692-706. Cortesi PA, Scalone L, Belisari A, et al. Cost and quality of life in patients with severe chronic hand eczema refractory to standard therapy with topical potent corticosteroids. Contact Dermatitis. 2014;70(3):158-168. Voorberg AN, Loman L, Schuttelaar MLA. Prevalence and Severity of Hand Eczema in the Dutch General Population: A Cross-sectional, Questionnaire Study within the Lifelines Cohort Study. Acta Derm Venereol. 2022;102:adv00626. Weidinger S, Novak N. Atopic dermatitis. Lancet. 2016;387(10023):1109-1122. Boguniewicz M, Leung DY. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011;242(1):233-246. Dudakov JA, Hanash AM, van den Brink MR. Interleukin-22: immunobiology and pathology. Annu Rev Immunol . 2015;33:747-785. Menter A, Korman NJ, Elmets CA, Feldman SR, Gelfand JM, Gordon KB, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 3. Guidelines of care for the management and treatment of psoriasis with topical therapies. J Am Acad Dermatol 2009; 60: 643-659. Psoriasis Statistics. National Psoriasis Foundation website. https://www.psoriasis.org/content/statistics . Accessed September, 2024. Hawkes JE, Chan TC, Krueger JG. Psoriasis pathogenesis and the development of novel targeted immune therapies. J Allergy Clin Immunol. 2017;140(3):645-653. Plaque Psoriasis. National Psoriasis Foundation website. https://www.psoriasis.org/plaque/ . Updated September 2020. Accessed August 16, 2024. Dubin C, Del Duca E, Guttman-Yassky E. Drugs for the Treatment of Chronic Hand Eczema: Successes and Key Challenges. Ther Clin Risk Manag. 2020;16:1319-1332. Erratum in: Ther Clin Risk Manag. 2021 Mar 18;17:233. Lee GR, Maarouf M, Hendricks AK, Lee DE, Shi VY. Current and emerging therapies for hand eczema. Dermatol Ther. 2019;32(3):e12840. Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy . 2020; 75:54-62. Popovic B, Breed J, Rees DG, et al. Structural Characterisation Reveals Mechanism of IL-13-Neutralising Monoclonal Antibody Tralokinumab as Inhibition of Binding to IL-13Rα1 and IL-13Rα2. J Mol Biol. 2017;429(2):208-219. Electronic Medicines Compendium. SmPC. Kyntheum (brodalumab). 10 Jan 2023. https://www.ema.europa.eu/en/documents/product-information/kyntheum-epar-product-information_en.pdf Accessed September, 2024. Thaçi D, et al. Efficacy and safety of IL-22R inhibition in patients with moderate-to-severe atopic dermatitis: results from a phase 2a monotherapy trial. Presented at the 2023 American Academy of Dermatology Annual Meeting; March 17–21 2023; New Orleans, LA. MAT-76322 September 2024

Phase 3Clinical ResultDrug ApprovalLicense out/inPhase 2

14 Mar 2024

·www.prnewswire.com

Psoriasis in America - Insights into Psoriasis Patient Demographics, Quality of Life, Information-seeking Behaviors, HCP Engagement and Treatment Experiences

DUBLIN, March 14, 2024 /PRNewswire/ -- The "Psoriasis in America 2023: Understanding the Psoriasis Patient Experience" report has been added to ResearchAndMarkets.com's offering. Approximately 7.5 million people in the United States have psoriasis. This Psoriasis in America report provides a comprehensive look at life for those living with psoriasis. Using detailed quantitative data, it gives a full picture of the psoriasis patient experience - from symptoms to treatment to HCP relationships to quality of life - so you can make informed, strategic decisions, identify opportunities, and understand potential challenges. The report offers an in-depth look at the psoriasis patient experience. This large-scale, patient-reported data leverages vital quantitative insights essential to understanding key touchpoints in the psoriasis patient journey, including condition management, HCP engagement, quality of life, treatment experience and satisfaction, and much more. This report lifts the curtain on life with psoriasis, giving stakeholders an actionable look at the behaviors, attitudes, perceptions, needs, and experiences of people living with the condition. Data can be used to inform strategic decisions, including product communications, competitive assessments, concept development, landscape analyses, patient journey overlays, and forecasting inputs. This report also addresses important questions that stakeholders may not even know to ask while offering valuable insights into must-have patient-reported data points not available anywhere else. Add-on custom data analysis opportunities are also available for an additional cost - please see the report following purchase for more information. The analyst reaches millions of people through its portfolio of 45+ condition-specific online health communities - including PlaquePsoriasis.com - to provide information, connection, and support to patients and caregivers in the U.S. This report includes a deep-dive into: Psoriasis patient demographics Age, gender, ethnicity, marital status, children, employment status, income, location, insurance, and other health conditions Impact of psoriasis on quality of life Severity, impact on quality of life, symptoms experienced, and what patients wish others better understood Information-seeking behaviors Information sources used, plus topics of interest HCP engagement Primary HCP seen for condition, satisfaction with HCP, and discussion about brands aware of/not used Psoriasis treatment awareness and experiences Aided awareness of specific treatments, treatment experience, satisfaction with current treatments, perceived control with current treatment plan, and interest/participation in clinical trials Key questions answered in this report: To what extent do people say psoriasis impacts their overall quality of life? What's the average number of flares in the past year? What do patients wish others understood about psoriasis? What percentage of patients see a specialist for psoriasis treatment? What treatments have the highest aided brand awareness among patients? What percentage of patients use a biologic? How many patients feel their psoriasis is well-controlled on their current treatment plan? What percentage of patients are likely to switch or add new treatments in the next six months? What medications have patients discussed with their HCP? What are the top online resources people with psoriasis use to find information? What kinds of content and information do patients search for? What percentage of patients search for information on treatment options? Methodology Psoriasis in America consists of: A 20-minute online quantitative survey, covering demographics, comorbidities, quality of life/impact, HCP interactions, as well as treatment awareness, experiences, and discussions Qualitative patient insights from open-ended responses Additional details: Fielded: January 16, 2023 to April 14, 2023 Convenience sample of 490 respondents diagnosed with psoriasis Respondents are age 18+, living in the U.S., and are recruited from proprietary online health communities and recruiting partners Key Topics Covered: Respondent Demographics Research Highlights Condition Status and Quality of Life Severity and Exacerbations Symptoms Experienced Impact on Quality of Life Qualitative Patient Insights Information-Seeking Behaviors Resources Used to Manage Health Types of Content/Information Sought Treatment Awareness and Experiences Primary HCP Seen for Psoriasis Care Aided Brand Awareness of Treatments Treatment Usage Condition Control on Current Treatment and Clinical Trial Interest Treatment Discussions with HCP Appendix with All Data Charts and Distributions Brands and treatments mentioned in this report include: Topical corticosteroid (such as hydrocortisone) BRYHALIT (halobetasol propionate) lotion DesOwen (desonide) SERNIVOT (betamethasone dipropionate) SORILUXT Foam (calcipotriene) TACLONEX (calcipotriene and betamethasone) TAZORAC (tazarotene) VECTICAL (calcitriol) VTAMA (tapinarof) ZITHRANOLT-RR (anthralin) ZORYVET (roflumilast) Acitretin (SORIATANE) ARAVA (leflunomide) Azathioprine (such as IMURAN, AZASAN) Cyclosporine (such as Sandimmune, NEORAL, RESTASIS) Methotrexate (eg, Rheumatrex), also sometimes given as an injection OTEZLA (apremilast) PLAQUENIL (hydroxychloroquine) RINVOQ (upadacitinib) SOTYKTUT (deucravacitinib) Sulfasalazine (Azulfidine) XELJANZ/XELJANZ XR (tofacitinib citrate) AMJEVITAT (adalimumab-atto) Hide until launched in US AVSOLA (infliximab-axxq) CIMZIA (certolizumab) COSENTYX (secukinumab) CYLTEZO (adalimumab-adbm) Hide until launched in US ENBREL (etanercept) ERELZIT (etanercept-szzs) Hide until launched in US HULIO (adalimumab-fkjp) Hide until launched in US HUMIRA (adalimumab) HYRIMOZ (adalimumab-adaz) Hide until launched in US ILUMYAT (tildrakizumab-asmn) INFLECTRA (infliximab-dyyb) IXIFIT (infliximab-qbtx) Hide until launched in US ORENCIA (abatacept) REMICADE (infliximab) RENFLEXIST (infliximab-abda) SIMPONI (golimumab) SIMPONI ARIA (golimumab for infusion) SILIQT (brodalumab) SKYRIZI (risankizumab-rzaa) STELARA (ustekinumab) TALTZ (ixekizumab) TREMFYA (guselkumab) For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

06 Oct 2023

·www.prnewswire.com

FDA approves Novartis Cosentyx® as first intravenous (IV) formulation interleukin-17A antagonist for rheumatic diseases

First new intravenous (IV) treatment option in six years for adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA)1-6 Cosentyx® (secukinumab) administered via IV infusion offers healthcare providers choice and flexibility to tailor treatment to their patients' unique needs With both IV and subcutaneous formulations, Cosentyx can now help a broader range of PsA, AS and nr-axSpA patients manage their condition EAST HANOVER, N.J., Oct. 6, 2023 /PRNewswire/ -- Novartis, a global leader in immuno-dermatology and rheumatology, announced today that the US Food and Drug Administration (FDA) has approved an intravenous (IV) formulation of Cosentyx® (secukinumab) for the treatment of adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA). Cosentyx is the only treatment approved in an IV formulation that specifically targets and blocks interleukin-17A (IL-17A), and the only non-tumor necrosis factor alpha (TNF-α) IV option available in all these indications. The IV formulation of Cosentyx offers patients a monthly 30-minute, weight-based dosing option, requiring no pre-medication and no lab monitoring.1 The new IV administration option will be available in Q4 of 2023. "A significant portion of the millions of PsA, AS and nr-axSpA patients in the US require treatment through IV infusions for a variety of reasons, including not being comfortable with self-injections or simply preferring to have treatments administered in their healthcare provider's office," said Philip J. Mease, M.D., Clinical Professor at the University of Washington School of Medicine and Director of Rheumatology Research at the Swedish Medical Center in Seattle, WA. "The approval of Cosentyx as an IV formulation is an important milestone for patients because it expands the treatment options available to them with a different mechanism of action than existing biologic IV therapies, along with the comfort and familiarity of an established treatment." "At Novartis, we are committed to ensuring healthcare providers and patients have treatment options available to meet their unique needs. With this approval of Cosentyx as an IV formulation, along with the subcutaneous formulation, we can broaden the use of Cosentyx to help more patients manage their condition with a medicine backed by more than a decade of clinical research and eight years of real-world experience," said Christy Siegel, Vice President and Head of Immunology, Novartis US. About Cosentyx ® (secukinumab) Cosentyx is a fully human biologic that specifically targets and blocks interleukin-17A (IL-17A), an important cytokine involved in the inflammation of psoriatic arthritis (PsA), moderate to severe plaque psoriasis, ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).7,8 Cosentyx is a proven medicine and has been studied clinically for more than 14 years. The medicine is backed by robust evidence, including 8 years of real-world data in adults and 5 years of long-term safety and efficacy in adults with moderate to severe plaque psoriasis, PsA and AS.1,9-15 These data strengthen the position of Cosentyx as a treatment across AS, nr-axSpA, PsA, moderate to severe plaque psoriasis (adult and pediatric) and two subtypes of juvenile idiopathic arthritis (JIA), enthesitis-related arthritis and juvenile psoriatic arthritis.1 More than 1 million patients have been treated with Cosentyx worldwide since its launch in 2015.16 Cosentyx is approved in more than 100 countries, most recently gaining approval for JIA and hidradenitis suppurativa in Europe.17-20 INDICATIONS COSENTYX® (secukinumab) is a prescription medicine used to treat: people 6 years of age and older with moderate to severe plaque psoriasis (PsO) that involves large areas or many areas of the body, and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light alone or with systemic therapy) people 2 years of age and older with active psoriatic arthritis (PsA) adults with active ankylosing spondylitis (AS) adults with active non-radiographic axial spondyloarthritis (nr-axSpA) and objective signs of inflammation people 4 years of age and older with active enthesitis-related arthritis (ERA) IMPORTANT SAFETY INFORMATION Do not use COSENTYX if you have had a severe allergic reaction to secukinumab or any of the other ingredients in COSENTYX. See the Medication Guide for a complete list of ingredients. What is the most important information I should know about COSENTYX? COSENTYX is a medicine that affects your immune system. COSENTYX may increase your risk of having serious side effects such as: Infections COSENTYX may lower the ability of your immune system to fight infections and may increase your risk of infections. Some people have died from these infections. Your doctor should check you for tuberculosis (TB) before starting treatment with COSENTYX. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with COSENTYX and during treatment with COSENTYX. Your doctor should watch you closely watch for signs and symptoms of TB during treatment with COSENTYX. Do not take COSENTYX if you have an active TB infection. Before starting COSENTYX, tell your doctor if you: are being treated for an infection have an infection that does not go away or that keeps coming back have TB or have been in close contact with someone with TB think you have an infection or have symptoms of an infection such as: fevers, sweats, or chills; muscle aches; cough; shortness of breath; blood in your phlegm; weight loss; warm, red, or painful skin or sores on your body; diarrhea or stomach pain; burning when you urinate or urinate more often than normal After starting COSENTYX, call your doctor right away if you have any signs of infection listed above. Do not use COSENTYX if you have any signs of infection unless you are instructed to by your doctor. What are the possible side effects of COSENTYX? COSENTYX may cause serious side effects, including: Inflammatory bowel disease New cases of inflammatory bowel disease or "flare-ups" can happen with COSENTYX and can sometimes be serious. If you have inflammatory bowel disease (ulcerative colitis or Crohn's disease), tell your doctor if you have worsening disease symptoms during treatment with COSENTYX or develop new symptoms of stomach pain or diarrhea. Serious allergic reactions Serious allergic reactions can occur. Get emergency medical help right away if you get any of the following symptoms: feeling faint; swelling of your face, eyelids, lips, mouth, tongue, or throat; trouble breathing or throat tightness; chest tightness; skin rash or hives (red, itchy bumps). If you have a severe allergic reaction, do not give another injection of COSENTYX. Severe skin reactions that look like eczema can happen during treatment with COSENTYX from days to months after your first dose and can sometimes lead to hospitalization. Your healthcare provider may temporarily stop treatment with COSENTYX if you develop severe skin reactions. Tell your healthcare provider if you have any of the following signs or symptoms: redness or rash, itching, small bumps or patches, your skin is dry or feels like leather, blisters on the hands or feet that ooze or become crusty and skin peeling. The most common side effects of COSENTYX include: cold symptoms, diarrhea, and upper respiratory infections. These are not all of the possible side effects of COSENTYX. Call your doctor for medical advice about side effects. Before using COSENTYX, tell your doctor if you: have any of the conditions or symptoms listed above for infections. have inflammatory bowel disease (Crohn's disease or ulcerative colitis). are allergic to latex. The needle cap on the COSENTYX Sensoready® pen, and 150 mg/mL and 75 mg/0.5 mL prefilled syringes contains latex. have recently received or are scheduled to receive an immunization (vaccine). People who take COSENTYX should not receive live vaccines. Children should be brought up to date with all vaccines before starting COSENTYX. have any other medical conditions and all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. are pregnant or plan to become pregnant. It is not known if COSENTYX can harm your unborn baby. You and your doctor should decide if you will use COSENTYX. are breastfeeding or plan to breastfeed. It is not known if COSENTYX passes into your breast milk. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Please click here for Cosentyx full Prescribing Information. Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About Novartis Novartis is a focused innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. Reimagine medicine with us: Visit us at and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. References Cosentyx Prescribing Information. East Handover, NJ: Novartis Pharmaceuticals Corp; October 2023. Taltz Prescribing Information. Indianapolis, IN: Eli Lilly and Company; September 2022. Siliq Prescribing Information. Bridgewater, NJ: Bausch Health US, LLC; April 2020. Remicade Prescribing Information. Horsham, PA: Janssen Biotech, Inc; October 2021. Orencia Prescribing Information. Princeton, NJ: Bristol Meyers Squibb Company; December 2021. Simponi Aria Prescribing Information. Horsham, PA: Janssen Biotech, Inc; February 2021. Girolomoni G, Mrowietz U and Paul C. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol. 2012;167:717-24. McGonagle DG, McInnes IB, Kirkham BW, et al. The role of IL-17A in axial spondyloarthritis and psoriatic arthritis: recent advances and controversies. Annals Rheum Dis. 2019;78:1167-1178. Baraliakos X, Braun J, Deodhar A, et al. Long-term efficacy and safety of secukinumab 150 mg in ankylosing spondylitis: 5-year results from the phase III MEASURE 1 extension study. RMD Open. 2019;5:e001005. Bissonnette R, Luger T, Thaçi D, et al. Secukinumab demonstrates high sustained efficacy and a favourable safety profile in patients with moderate-to-severe psoriasis through 5 years of treatment (SCULPTURE Extension Study). J Eur Acad Dermatol Venereol. 2018;32:1507-1514. Mease PJ, Kavanaugh A, Reimold A, et al. Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Psoriatic Arthritis: Final 5-year Results from the Phase 3 FUTURE 1 Study. ACR Open Rheumatol. 2020;2:18-25. Data on file. CAIN457F2310 (MEASURE 1 and 2): Pooled Safety Data. Novartis Pharmaceuticals Corp; July 23, 2018. Data on file. CAIN457F2310 and CAIN457F2305 summary of 5-year clinical safety in (ankylosing spondylitis). Novartis Pharmaceuticals Corp; May 2019. Data on file. CAIN457F2312 Data Analysis Report. Novartis Pharmaceuticals Corp; November 2008. McInnes IB, Mease PJ, Kirkham B, et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 2015;386:1137-46. Data on file. COSENTYX Access. Novartis Pharmaceuticals Corp; January 2023. Gottlieb AB, Deodhar A, Mcinnes IB, et al. Long-term Safety of Secukinumab Over Five Years in Patients with Moderate-to-severe Plaque Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis: Update on Integrated Pooled Clinical Trial and Post-marketing Surveillance Data. Acta Derm Venereol. 2022;102:adv00698. Novartis AG. 2021. Novartis Cosentyx® receives FDA approval for the treatment of children and adolescents with enthesitis-related arthritis and psoriatic arthritis. [Press release]. Available at: [Last accessed: February 2023]. Novartis AG. 2022. Novartis Cosentyx® (secukinumab) receives positive CHMP opinion for expanded use in childhood arthritic conditions. [Press release]. Available at: [Last accessed: February 2023]. Novartis Europharm Limited. Cosentyx® (secukinumab): Summary of Product Characteristics. Available at: [Last accessed: September 2023]. # # # SOURCE Novartis Pharmaceuticals Corporation

Phase 3Drug ApprovalClinical ResultImmunotherapy

100 Deals associated with Brodalumab

External Link

KEGG	Wiki	ATC	Drug Bank
D10061	Brodalumab	L04AC12	DB11776

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Ankylosing Spondylitis	Japan	Kyowa Kirin Co., Ltd.	27 Nov 2020
Spondylarthritis	Japan	Kyowa Kirin Co., Ltd.	27 Nov 2020
Arthritis, Psoriatic	Japan	Kyowa Kirin Co., Ltd.	04 Jul 2016
Plaque psoriasis	Japan	Kyowa Kirin Co., Ltd.	04 Jul 2016
Psoriasis	Japan	Kyowa Kirin Co., Ltd.	04 Jul 2016

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pustulosis of Palms and Soles	Phase 3	Japan	Kyowa Kirin Co., Ltd.	10 Aug 2019
CREST Syndrome	Phase 3	Japan	Kyowa Kirin Co., Ltd.	23 May 2019
Scleroderma, Systemic	Phase 3	Japan	Kyowa Kirin Co., Ltd.	23 May 2019
Axial Spondyloarthritis	Phase 3	Japan	Kyowa Kirin Co., Ltd.	07 Mar 2017
Axial Spondyloarthritis	Phase 3	South Korea	Kyowa Kirin Co., Ltd.	07 Mar 2017
Axial Spondyloarthritis	Phase 3	Taiwan Province	Kyowa Kirin Co., Ltd.	07 Mar 2017
Psoriasis vulgaris	Phase 3	Japan	Kyowa Kirin Co., Ltd.	01 Feb 2014
Erythrodermic psoriasis	Phase 3	Japan	Kyowa Kirin Co., Ltd.	01 Feb 2013
Generalized Pustular Psoriasis	Phase 3	Japan	Kyowa Kirin Co., Ltd.	01 Feb 2013
Crohn Disease	Phase 2	United States	Amgen, Inc.	09 Nov 2010

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04061252 (Pubmed) Manual	Phase 3	Pustulosis of Palms and Soles interleukin-17 pathway activation	126	Brodalumab 210 mg	kpnrscrbei(yiamtedngf) = rpzdxgmbzd cubkrlfpdj (qahppygepc, 10.91 - 16.56) View more	Positive	02 Jul 2024
NCT04061252 (Pubmed) Manual	Phase 3		126	Placebo	kpnrscrbei(yiamtedngf) = rntkweduin cubkrlfpdj (qahppygepc, 5.76 - 11.13) View more	Positive	02 Jul 2024
NCT04305327 (EMBRACE 1, CTgov)	Phase 3	Plaque psoriasis \| Chronic large plaque psoriasis	12	Brodalumab (Brodalumab)	cykkiksrah = hmatjhqgen gvyxivswyf (wxfbhmwfqy, xdtbhqfrsv - qngyjoqnga) View more	-	28 Feb 2024
NCT04305327 (EMBRACE 1, CTgov)	Phase 3	Plaque psoriasis \| Chronic large plaque psoriasis	12	ustekinumab (Ustekinumab)	hmamoocazv = ozdvpxeseo myqylugnjn (sfqiogpeyl, fbwzdgvrca - mgzudmxizx) View more	-	28 Feb 2024
NCT04533737 (COBRA, Pubmed) Manual	Phase 4	Psoriasis	113	Brodalumab 210 mg	pacdidogac(azauicgwoj) = hdizvwsuzc pxpurzkrfi (xdnygtljby )	Positive	01 Feb 2024
NCT04533737 (COBRA, Pubmed) Manual	Phase 4	Psoriasis	113	Guselkumab 100 mg	pacdidogac(azauicgwoj) = dlpudztewi pxpurzkrfi (xdnygtljby )	Positive	01 Feb 2024
NCT04533737 (COBRA, CTgov)	Phase 4	Plaque psoriasis \| Psoriasis vulgaris	113	Placebo+Brodalumab (Arm 1 (Brodalumab + Dummy 1))	kurwycwvfs(soldmdmwcn) = hxbmafnpks iiedzpznmh (lsfphazqux, ljilrfliws - tbnunixegj) View more	-	09 Jan 2024
NCT04533737 (COBRA, CTgov)	Phase 4	Plaque psoriasis \| Psoriasis vulgaris	113	Placebo+Guselkumab (Arm 2 (Guselkumab + Dummy 2))	kurwycwvfs(soldmdmwcn) = vjtruehppe iiedzpznmh (lsfphazqux, eqdwerfvyb - pqrtyxkqwf) View more	-	09 Jan 2024
JPRN-jRCTs041190114 (ESPRIT, EADV2023)	Not Applicable	Psoriasis IL17C \| IL1A \| IL36B ... View more	40	Brodalumab 210 mg	fxamakjfqj(hglmravjtd) = IL17C was decreased by 85% as early as week 4 uatlfoihbe (ktggkshrmm )	Positive	11 Oct 2023
ODIN (EADV2023)	Not Applicable	-	87	Brodalumab	osjlcsmzri(wwsazcninv) = kuhtveepje splipapiok (jkmzmesdzw ) View more	Positive	11 Oct 2023
LIBERO VISIBLE (EADV2023)	Not Applicable	Visible Lesion	490	Brodalumab 210 mg	mrsvjbkcsb(mznslswaqn) = zttxnrvefq hlzmqeggwt (dbffqcqzfi )	-	11 Oct 2023
ReSOLVE study (EADV2023)	Not Applicable	Plaque psoriasis	90	Brodalumab	mdccnimhdi(yrffgpaiva) = rhoxgljzxi kzvuplylnq (eqgmnpzsdz ) View more	Positive	11 Oct 2023
EADV2023	Not Applicable	Psoriasis	-	Brodalumab	izvpwevqyp(wojmdkfqnp) = arkbumrawb zimhimkuxs (nimvxdvraa )	Positive	11 Oct 2023
BROACTIVE Study (EADV2023)	Not Applicable	Plaque psoriasis	172	Brodalumab	bumehgerpw(xchlyocorw) = jndcfwlsbd rxbufxjlmn (dimtupxbsb )	Positive	11 Oct 2023

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