Optimising Arthritis Strategies in Elderly patients (≥70 years) with rheumatoid arthritis in sustained low disease activity (the OASE study): A Prospective Target Trial Emulation Study Evaluating Tapering of Disease-Modifying Anti-Rheumatic Drugs vs. Usual Care Based on Patient Preference

Start Date01 Oct 2026

Sponsor / Collaborator

Aalborg University Hospital

NCT07704580

/ RecruitingPhase 1/2

A Randomized Open Label, Phase 1b/2 Study to Evaluate Intravenous Administration With Long Dosing Interval Regimens of Sarilumab in Adult Participants With Rheumatoid Arthritis

This is a Phase 1/Phase 2 study with:
* 5-arms design for Part A;
* and a single arm for Part B.
The purpose of this study is to measure PK parameters and safety with sarilumab intravenous (IV) with or without concomitant oral conventional synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) in male and female participants with moderately to severely active rheumatoid arthritis aged 18 years of age or older.
Study details include:
* The study duration will be up to 64 weeks.
* The treatment duration will be up to 6 months for each study phase.
* Part A has 10 visits, including a post-treatment end of study (EOS) follow-up visit.
* For participants entering the open label extension to receive the approved 200 mg sarilumab every two weeks (Q2W) dose, there will be 3 additional study visits.
* For the intra-study sarilumab 200 mg Q2W subcutaneous (SC) arm, participants will be evaluated over the course of 24 weeks plus post-treatment EOS follow-up visit following the schedule of activities (SoA) of Part A from Day -1 to Day 29 (total of 8 visits) and the SoA of Part B from Week 4 to Week 24 (total of 8 visits) and a post-treatment end of study (EOS) follow-up visit at Week 30 (Part B) for a total of 17 visits, including a post-treatment EOS follow-up visit.
* Part B has 13 visits, including a post-treatment EOS follow-up visit.

Start Date02 Jul 2026

Sponsor / Collaborator

Sanofi

[+1]

NCT07484113

/ Not yet recruitingPhase 1IIT

IL6-receptor Inhibitor in Combination With Belumosudil for the Treatment of Belumosudil-refractory Chronic Graft-versus-host Disease (cGVHD)

A single-center, Phase 1, open-label, investigator-initiated clinical trial evaluating the safety, tolerability, and preliminary efficacy of sarilumab (anti-IL-6R) monotherapy as a rescue in adult patients with belumosudil-refractory chronic graft-versus-host disease (cGVHD).

Start Date01 Jul 2026

Sponsor / Collaborator

Stanford University

100 Clinical Results associated with Sarilumab

100 Translational Medicine associated with Sarilumab

100 Patents (Medical) associated with Sarilumab

737

Literatures (Medical) associated with Sarilumab

01 Aug 2026·JOURNAL OF CRITICAL CARE

The association between interleukin-6 inhibitors as treatment for COVID-19 and mental health problems in ICU survivors

Article

Author: van den Boogaard, Mark ; van Gelder, Thomas G ; van Diem-Zaal, Irene J ; Zegers, Marieke ; Egberts, Toine C G ; Slooter, Arjen J C ; Lalmohamed, Arief

OBJECTIVE:

To assess whether exposure to interleukin-6 (IL-6) inhibitors as treatment for critically ill COVID-19 patients is associated with a lower prevalence of mental health problems one year after ICU admission.

DESIGN:

Retrospective cohort study using prospectively collected outcome data.

SETTING:

Two university medical centers in the Netherlands: University Medical Center Utrecht (UMCU) and Radboud University Medical Center (Radboudumc).

PATIENTS:

Adult ICU survivors admitted to the ICU for COVID-19 from September 1, 2020, to March 31, 2022, with available one-year follow-up data.

EXPOSURE:

IL-6 inhibitors (tocilizumab or sarilumab) as treatment for COVID-19.

MEASUREMENTS AND MAIN RESULTS:

Mental health problems were assessed using the Impact of Event Scale (IES-6 or IES-R) for post-traumatic stress disorder (PTSD) and the Hospital Anxiety and Depression Scale (HADS) for anxiety and depression. The primary outcome was a composite of PTSD, anxiety, and/or depression symptoms one year after ICU admission. Among 170 patients included in the primary analysis (119 exposed to IL-6 inhibitors, 51 unexposed), IL-6 inhibitor exposure was associated with a lower prevalence of mental health problems (adjusted odds ratio (aOR) 0.46, 95% confidence interval (CI) 0.22-0.93) and PTSD symptoms alone (aOR 0.45, 95% CI 0.20-0.97). No significant associations were found for anxiety (aOR 0.77, 95% CI 0.34-1.72) or depression (aOR 0.71, 95% CI 0.33-1.50) symptoms alone.

CONCLUSIONS:

Exposure to IL-6 inhibitors as treatment for critically ill COVID-19 patients was associated with a lower prevalence of mental health problems, primarily driven by a lower prevalence of PTSD symptoms, one year after ICU admission. These findings suggest a potential role for cytokine-targeted therapies in mitigating long-term mental health problems in ICU survivors, but further research is needed to establish causality.

KEY POINTS:

Question: Does treatment with interleukin-6 (IL-6) inhibitors during ICU admission for COVID-19 reduce the prevalence of mental health problems one year later?

FINDINGS:

In this multicenter cohort study of 170 COVID-19 ICU survivors, IL-6 inhibitor exposure was associated with a significantly lower prevalence of PTSD and of the composite outcome of PTSD, anxiety, or depression symptoms one year after ICU admission. Meaning: These findings suggest that IL-6 inhibition during critical illness may help mitigate long-term psychological burden in ICU survivors.

03 Jun 2026·RHEUMATOLOGY

Comparative effectiveness and safety of sarilumab vs JAK inhibitors in late- and younger-onset rheumatoid arthritis

Article

Author: Tomita, Daisuke ; Horita, Masahiro ; Itami, Tetsu ; Okano, Tadashi ; Nishida, Keiichiro ; Miyamoto, Toshiaki ; Kotani, Takuya ; Okano, Takaichi ; Hino, Shoichi ; Kinoshita, Koji ; Hatta, Kazunari ; Rai, Shinya ; Miyake, Hirofumi ; Yamada, Yutaro ; Wada, Yumiko ; Kishimoto, Kazuya ; Mamoto, Kenji ; Hidaka, Toshihiko ; Takeuchi, Tohru ; Saegusa, Jun ; Nozaki, Yuji

Abstract:

Objectives:

Glucocorticoid (GC)- and MTX-sparing strategies are clinically important in RA, yet comparative real-world evidence for sarilumab (SAR) vs Janus kinase inhibitors (JAKi) is limited. Whether treatment effects differ by age at onset—late-onset RA (LORA) vs young-onset RA (YORA)—also remains unclear. This study aimed to compare the effectiveness and safety of SAR and JAKi in patients with LORA and YORA.

Methods:

We conducted a multicentre real-world cohort study of adults with RA initiating SAR or a JAKi. Outcomes over 12 months included change from baseline in MTX dose (ΔMTX, mg/week) and GC dose (ΔGC, mg/day), cumulative treatment discontinuation and change in Clinical Disease Activity Index (CDAI). Analyses were performed within LORA and YORA strata, and propensity score matching (PSM) was applied separately in each stratum to balance baseline characteristics. Sensitivity analyses were conducted in the matched cohorts.

Results:

Both SAR and JAKi were associated with progressive tapering of concomitant MTX and GC during follow-up. SAR was associated with a higher frequency of MTX discontinuation compared with JAKi. In contrast, GC discontinuation and CDAI improvement were broadly similar between treatments across age strata and MTX subgroups. Findings were consistent after PSM and in sensitivity analyses within both LORA and YORA.

Conclusion:

In routine clinical practice, SAR and JAKi support de-escalation of concomitant therapy. SAR may permit earlier MTX withdrawal without loss of disease control, with comparable GC tapering and disease activity improvement in both LORA and YORA.

01 Jun 2026·JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

Modeling, Simulation, and Extrapolation to Optimize Pediatric Development Plan: Sarilumab Polyarticular-Course juvenile arthritis Application

Article

Author: Liu, Ying ; Abdallah, Hisham ; Meng, Zhaoling ; Xu, Christine ; De Benedetti, Fabrizio ; Zhang, Mei ; Kanamaluru, Vanaja ; Baret-Cormel, Lydie

Polyarticular-course juvenile idiopathic arthritis (pcJIA) is a chronic condition that manifests before the age of 16 years, with pathology similar to that of adult rheumatoid arthritis (RA). Sarilumab is an interleukin-6 receptor inhibitor approved for RA and pcJIA. To obtain the approval for pcJIA, a single-arm, multiple-dose phase 2 study was conducted to determine the sarilumab dose for pcJIA. The population pharmacokinetics analysis of the phase 2 dose-finding portion data showed comparable pharmacokinetics; exposure–response analyses demonstrated similar or greater efficacy (JIA-ACR30/50/70), and consistent safety (reduction in absolute neutrophil count) in patients with pcJIA compared with adult patients with RA at similar sarilumab exposure. Based on the adult-to-pediatric extrapolation concept and justifications using modeling and simulation, the phase 2 sample size was increased to generate sufficient efficacy and safety data and evidence at selected doses and the requirement for a randomized controlled study in patients with pcJIA was waived. This novel approach enabled the pcJIA dose proposal by aligning with adult RA exposures, streamlined clinical development by removing the control arm requirement and minimized children participation while ensuring robustness of sarilumab efficacy and safety evidence for approval.

259

News (Medical) associated with Sarilumab

22 Jun 2026

·www.biospace.com

Cemdisiran Regulatory Submissions Accepted for Review by FDA and EMA for the Treatment of Generalized Myasthenia Gravis (gMG)

Cemdisiran could be the first siRNA approved for the treatment of gMG and only therapy to be offered subcutaneously with four times a year dosing FDA accepted NDA under Priority Review with a target action date in November 2026; European Commission decision anticipated in the second half of 2027 TARRYTOWN, N.Y., June 22, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted the regulatory applications for cemdisiran to treat adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive. The FDA will review the New Drug Application (NDA) under Priority Review with a target action date in November 2026, following use of a Priority Review Voucher. A decision from the European Commission is anticipated in the second half of 2027. The submissions are supported by data from the Phase 3 NIMBLE trial evaluating cemdisiran, dosed subcutaneously every 12 weeks, in adults with symptomatic gMG who may be receiving standard of care immunosuppressants based on the investigator’s discretion. Full data from NIMBLE, which is one of the largest global, interventional gMG trials conducted to date, were simultaneously published in The Lancet and presented at the American Academy of Neurology (AAN) Annual Meeting in April 2026 . A regulatory filing in Japan is also planned for early 2027. MG is a rare and chronic autoimmune disease where abnormal anti-AChR antibodies activate the complement system including C5, disrupting communication between nerves and muscles that results in debilitating and potentially life-threatening muscle weakness. Worldwide, an estimated 150 to 200 out of every million people have MG. In the U.S., the disease impacts approximately 85,000 people. Initial manifestations are usually ocular, but approximately 85% of MG patients experience progression to additional disease manifestations, which is then categorized as generalized MG. For these patients, the disease affects muscles throughout the body, resulting in extreme fatigue and difficulties with facial expression, speech, swallowing and mobility. For patients living with gMG, many continue to experience challenges with disease management including treatments that only address symptoms, long-term burden of immunosuppressants, lack of responsiveness as well as waning effectiveness, which can all affect their quality of life. The safety and efficacy of cemdisiran, as well as its potential use for the treatment of gMG, are investigational and have not been fully evaluated or approved by any regulatory authority. Regeneron is solely responsible for the development, manufacturing, and commercialization of cemdisiran as a monotherapy and in combination with C5 antibodies through a worldwide licensing agreement with Alnylam. About Regeneron's VelocImmune Technology Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite ® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved or authorized fully human monoclonal antibodies. This includes REGEN-COV ® (casirivimab and imdevimab), Dupixent ® (dupilumab), Libtayo ® (cemiplimab-rwlc), Praluent ® (alirocumab), Kevzara ® (sarilumab), Evkeeza ® (evinacumab-dgnb), Inmazeb ® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz ® (pozelimab). About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite ® , which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center ® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases. For more information, please visit or follow Regeneron on LinkedIn , Instagram , Facebook or X . Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation cemdisiran (an investigational siRNA therapeutic targeting C5); the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, including cemdisiran for the treatment of adults with generalized myasthenia gravis in the United States and/or European Union as discussed in this press release as well as cemdisiran as a monotherapy or in combination with pozelimab (a C5 antibody) for the treatment of other complement-mediated disorders (including paroxysmal nocturnal hemoglobinuria and/or geographic atrophy secondary to age-related macular degeneration); uncertainty of the utilization, market acceptance, and/or commercial success of Regeneron’s Products and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron’s Products and Regeneron’s Product Candidates (such as cemdisiran and pozelimab); the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; safety issues resulting from the administration of Regeneron’s Products and Regeneron’s Product Candidates (such as cemdisiran and pozelimab) in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement or copay assistance for Regeneron’s Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes to drug pricing regulations and requirements and Regeneron’s pricing strategy, including in connection with Regeneron’s April 2026 agreements with the U.S. government; other changes in laws, regulations, and policies affecting the healthcare industry; competing products and product candidates (including biosimilar products) that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron's business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2025 and its Form 10-Q for the quarterly period ended March 31, 2026. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website ( ) and its LinkedIn page ( ). Contacts: Media Relations Tammy Allen Tel: +1 914-306-2698 tammy.allen@regeneron.com Investor Relations Mark Hudson Tel: +1 914-847-3482 mark.hudson@regeneron.com

License out/inPriority ReviewPhase 3NDADrug Approval

04 Jun 2026

·www.biospace.com

Novartis Cosentyx® PMR data in New England Journal of Medicine showed sustained remission vs placebo in twice as many patients

Clinically meaningful, statistically significant efficacy achieved in primary and all secondary endpoints, including reduced steroid use; safety consistent with established Cosentyx profile 1,2 Polymyalgia rheumatica (PMR) is an inflammatory rheumatic disease primarily affecting people over 50; extended steroid use associated with poor outcomes with limited advanced treatments 3 - 7 Data have been submitted for health authority review in US, EU and Japan; additional country filings to follow throughout 2026 Basel, June 3, 2026 – Novartis presented today new Cosentyx® (secukinumab) data in polymyalgia rheumatica (PMR) demonstrating a statistically significant, clinically meaningful difference in sustained remission rates vs placebo and significant steroid sparing 8 . Published in the New England Journal of Medicine and simultaneously presented at the 2026 European Alliance of Associations for Rheumatology (EULAR) Congress, Phase III REPLENISH data showed that the effect of Cosentyx treatment was sustained through week 52 in this investigational use 8 . “PMR is an inflammatory rheumatic disease, characterized by disabling pain and stiffness in shoulders and pelvic girdle. There is an unmet need for a treatment that keeps symptoms under control over time with fewer relapses —while also reducing reliance on steroids,” said Prof Christian Dejaco, Director, Dept of Rheumatology, South Tyrol Health Trust, Bruneck, Italy. “I am encouraged by the REPLENISH trial results which showed that Cosentyx, with its known safety profile, can reduce flares in the longer term while lowering patients’ steroid exposure.” All primary and secondary endpoints of the REPLENISH trial were met across both Cosentyx 300mg and 150mg treatment arms, including complete sustained remission and time until patients needed additional treatment through week 52 8 . No new safety signals were identified in PMR patients receiving Cosentyx 8 . "The publication of the REPLENISH data in the New England Journal of Medicine reflects the importance of these findings for patients with polymyalgia rheumatica (PMR), a disease with very limited advanced treatment options,” said Prof John Stone, MD, MPH, Professor of Medicine, Harvard Medical School, Massachusetts General Hospital, Boston, global principal investigator for the REPLENISH trial and lead author of the New England Journal of Medicine article. “The Phase III results showed a higher proportion of PMR patients achieved sustained remission with Cosentyx and further support IL-17A inhibition as a promising therapeutic approach in this disease.” “Today’s results demonstrate that Cosentyx fills an unmet need by providing relief and renewed hope for people living with polymyalgia rheumatica (PMR) through improvement in disease control while reducing steroid use,” said Angelika Jahreis, Global Head, Immunology Development, Novartis. “We look forward to working with health authorities globally to expand the use of Cosentyx supported by the new REPLENISH data.” Key efficacy results at week 52 8 Endpoint Cosentyx 300mg Cosentyx 150mg Placebo Sustained remission 41.2% * 40.6% * 20.4% Mean adjusted annual cumulative glucocorticoid dose 1604 mg * 1683 mg # 2093 mg * P-value < 0.001; adjusted for multiple testing # P-value = 0.0015; adjusted for multiple testing Novartis has submitted Cosentyx for polymyalgia rheumatica for health authority review in the US, EU and Japan. Regulatory submissions in additional countries are expected to follow throughout 2026. About Cosentyx Cosentyx is a fully human biologic that directly inhibits interleukin-17A, an important cytokine involved in the inflammation underlying multiple immune-mediated inflammatory diseases. It is approved for use in adults with psoriatic arthritis (PsA), moderate to severe plaque psoriasis (PsO), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), and hidradenitis suppurativa (HS) 9-11 . Cosentyx is also approved for use in pediatric patients, including those with PsO, juvenile idiopathic arthritis subtypes such as juvenile psoriatic arthritis (JPsA) and enthesitis-related arthritis (ERA), and in the U.S. for pediatric patients aged 12 years and older with moderate to severe HS and juvenile AS 9-16 . About REPLENISH trial The REPLENISH trial (NCT05767034) is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted across 27 countries, evaluating the efficacy and safety of Cosentyx in patients with polymyalgia rheumatica (PMR). Patients were randomized into three treatment arms: Cosentyx 300mg, Cosentyx 150mg, or placebo, all in combination with a 24-week steroid taper regimen. The primary endpoint of the trial was to assess whether Cosentyx 300mg s.c. plus a 24-week steroid taper is superior to placebo plus a 24-week steroid taper in achieving sustained remission at week 52. Key secondary endpoints included the proportion of patients achieving complete sustained remission at week 52, the adjusted annual cumulative steroid dose, and the time to first use of escape or rescue treatment through week 52 17 . About polymyalgia rheumatica (PMR) Polymyalgia rheumatica (PMR) is a common inflammatory rheumatic disease in adults aged 50 years and older, typically characterized by acute pain and stiffness in the shoulders, neck, and hips 3 . Relapses are frequent, affecting up to 40% of patients in the first year 5 , and long-term steroid use, the standard of care, carries significant risks including osteoporosis and diabetes 1 8 . Beyond physical complications, PMR substantially impairs quality of life through pain, fatigue, restricted mobility, and fear of relapse 5,19,20 . About Novartis Immunology At Novartis, we’re advancing bold science with the goal of bringing relief and a renewed sense of hope to people living with autoimmune diseases. Building on our legacy of first-in-class innovation across rheumatology, dermatology and allergy, and a diverse industry-leading pipeline, we’re committed to shaping what’s next in Immunology. 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 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 an 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 300 million people worldwide. Reimagine medicine with us: Visit us at and connect with us on LinkedIn , Facebook , X/Twitter and Instagram . References Stone J, et al [abstract]. IVW 2026 Sun R, et al. Dermatol Ther (Heidelb). 2024;14(3):729-743; Espígol-Frigolé G, et al. Lancet. 2023;402(10411):1459–72. Gabriel SE, et al. Arthritis Rheum. 1997;40(10):1873–8. Floris A, et al. Clin Rheumatol. 2022;41(1):19-31 Kevzara US PI. Available at: Kevzara Label (fda) Accessed: 20 Jan 2025 Kevzara: EPAR - Product Information. Available at: Kevzara. INN-sarilumab . Accessed: 20 Jan 2025 Dejaco C, et al. Oral Presentation #OP0116. EULAR 2026 Novartis Europharm Limited. Cosentyx® (secukinumab): Summary of Product Characteristics. Available at: Cosentyx, INN-secukinumab [Last accessed: May 2026]. Girolomoni G, Mrowietz U and Paul C. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol 2012; 167: 717-724. Novartis Cosentyx shows clinically meaningful symptom improvements in patients with hidradenitis suppurativa. [Press release]. Available at: [Last accessed: May 2026]. Novartis Cosentyx receives FDA approval for treatment of children and adolescents with moderate to severe plaque psoriasis [Press release]. Available at: [Last accessed: May 2026]. 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: May 2026]. Novartis Cosentyx receives positive CHMP opinion for expanded use in childhood arthritic conditions. [Press release]. Available at: [Last accessed: May 2026]. Novartis Cosentyx® receives FDA approval for pediatric patients aged 12+ with moderate to severe hidradenitis suppurativa. [Press release]. Available at: [Last accessed: May 2026]. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp. ClinicalTrials.gov. NCT05767034.[Last accessed: May2026] Mazzantini M, et al. J Rheumatol. 2012 Mar;39(3):552-7. Hutchings A, et al. Arthritis Rheum. 2007;57(5):803–9 Mackie S.L, et al. Rheumatol Adv Pract. 2025 Dec 2;10(1):rkaf140. doi: 10.1093/rap/rkaf140 # # # Novartis Media Relations E-mail: media.relations@novartis.com Novartis Investor Relations Central investor relations line: +41 61 324 7944 E-mail: investor.relations@novartis.com

Clinical ResultPhase 3Drug Approval

03 Jun 2026

·www.novartis.com

Novartis Cosentyx® PMR data in New England Journal of Medicine showed sustained remission vs placebo in twice as many patients

Clinically meaningful, statistically significant efficacy achieved in primary and all secondary endpoints, including reduced steroid use; safety consistent with established Cosentyx profile1,2 Polymyalgia rheumatica (PMR) is an inflammatory rheumatic disease primarily affecting people over 50; extended steroid use associated with poor outcomes with limited advanced treatments3-7 Data have been submitted for health authority review in US, EU and Japan; additional country filings to follow throughout 2026 Basel, June 3, 2026 – Novartis presented today new Cosentyx® (secukinumab) data in polymyalgia rheumatica (PMR) demonstrating a statistically significant, clinically meaningful difference in sustained remission rates vs placebo and significant steroid sparing8. Published in the New England Journal of Medicine and simultaneously presented at the 2026 European Alliance of Associations for Rheumatology (EULAR) Congress, Phase III REPLENISH data showed that the effect of Cosentyx treatment was sustained through week 52 in this investigational use8. “PMR is an inflammatory rheumatic disease, characterized by disabling pain and stiffness in shoulders and pelvic girdle. There is an unmet need for a treatment that keeps symptoms under control over time with fewer relapses —while also reducing reliance on steroids,” said Prof Christian Dejaco, Director, Dept of Rheumatology, South Tyrol Health Trust, Bruneck, Italy. “I am encouraged by the REPLENISH trial results which showed that Cosentyx, with its known safety profile, can reduce flares in the longer term while lowering patients’ steroid exposure.” All primary and secondary endpoints of the REPLENISH trial were met across both Cosentyx 300mg and 150mg treatment arms, including complete sustained remission and time until patients needed additional treatment through week 528. No new safety signals were identified in PMR patients receiving Cosentyx8. "The publication of the REPLENISH data in the New England Journal of Medicine reflects the importance of these findings for patients with polymyalgia rheumatica (PMR), a disease with very limited advanced treatment options,” said Prof John Stone, MD, MPH, Professor of Medicine, Harvard Medical School, Massachusetts General Hospital, Boston, global principal investigator for the REPLENISH trial and lead author of the New England Journal of Medicine article. “The Phase III results showed a higher proportion of PMR patients achieved sustained remission with Cosentyx and further support IL-17A inhibition as a promising therapeutic approach in this disease.” “Today’s results demonstrate that Cosentyx fills an unmet need by providing relief and renewed hope for people living with polymyalgia rheumatica (PMR) through improvement in disease control while reducing steroid use,” said Angelika Jahreis, Global Head, Immunology Development, Novartis. “We look forward to working with health authorities globally to expand the use of Cosentyx supported by the new REPLENISH data.” Key efficacy results at week 528 Endpoint Cosentyx 300mg Cosentyx 150mg Placebo Sustained remission 41.2%* 40.6%* 20.4% Mean adjusted annual cumulative glucocorticoid dose 1604 mg* 1683 mg# 2093 mg * P-value < 0.001; adjusted for multiple testing# P-value = 0.0015; adjusted for multiple testing Novartis has submitted Cosentyx for polymyalgia rheumatica for health authority review in the US, EU and Japan. Regulatory submissions in additional countries are expected to follow throughout 2026. About CosentyxCosentyx is a fully human biologic that directly inhibits interleukin-17A, an important cytokine involved in the inflammation underlying multiple immune-mediated inflammatory diseases. It is approved for use in adults with psoriatic arthritis (PsA), moderate to severe plaque psoriasis (PsO), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), and hidradenitis suppurativa (HS)9-11. Cosentyx is also approved for use in pediatric patients, including those with PsO, juvenile idiopathic arthritis subtypes such as juvenile psoriatic arthritis (JPsA) and enthesitis-related arthritis (ERA), and in the U.S. for pediatric patients aged 12 years and older with moderate to severe HS and juvenile AS9-16. About REPLENISH trial The REPLENISH trial (NCT05767034) is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted across 27 countries, evaluating the efficacy and safety of Cosentyx in patients with polymyalgia rheumatica (PMR). Patients were randomized into three treatment arms: Cosentyx 300mg, Cosentyx 150mg, or placebo, all in combination with a 24-week steroid taper regimen. The primary endpoint of the trial was to assess whether Cosentyx 300mg s.c. plus a 24-week steroid taper is superior to placebo plus a 24-week steroid taper in achieving sustained remission at week 52. Key secondary endpoints included the proportion of patients achieving complete sustained remission at week 52, the adjusted annual cumulative steroid dose, and the time to first use of escape or rescue treatment through week 5217. About polymyalgia rheumatica (PMR) Polymyalgia rheumatica (PMR) is a common inflammatory rheumatic disease in adults aged 50 years and older, typically characterized by acute pain and stiffness in the shoulders, neck, and hips3. Relapses are frequent, affecting up to 40% of patients in the first year5, and long-term steroid use, the standard of care, carries significant risks including osteoporosis and diabetes18. Beyond physical complications, PMR substantially impairs quality of life through pain, fatigue, restricted mobility, and fear of relapse5,19,20. About Novartis Immunology At Novartis, we’re advancing bold science with the goal of bringing relief and a renewed sense of hope to people living with autoimmune diseases. Building on our legacy of first-in-class innovation across rheumatology, dermatology and allergy, and a diverse industry-leading pipeline, we’re committed to shaping what’s next in Immunology. 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 an 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 300 million people worldwide. Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. References Stone J, et al [abstract]. IVW 2026 Sun R, et al. Dermatol Ther (Heidelb). 2024;14(3):729-743; Espígol-Frigolé G, et al. Lancet. 2023;402(10411):1459–72. Gabriel SE, et al. Arthritis Rheum. 1997;40(10):1873–8. Floris A, et al. Clin Rheumatol. 2022;41(1):19-31 Kevzara US PI. Available at: Kevzara Label (fda) Accessed: 20 Jan 2025 Kevzara: EPAR - Product Information. Available at: Kevzara. INN-sarilumab. Accessed: 20 Jan 2025 Dejaco C, et al. Oral Presentation #OP0116. EULAR 2026 Novartis Europharm Limited. Cosentyx® (secukinumab): Summary of Product Characteristics. Available at: Cosentyx, INN-secukinumab [Last accessed: May 2026]. Girolomoni G, Mrowietz U and Paul C. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol 2012; 167: 717-724. Novartis Cosentyx shows clinically meaningful symptom improvements in patients with hidradenitis suppurativa. [Press release]. Available at: https://www.novartis.com/news/media-releases/novartis-cosentyx-shows-clinically-meaningful-symptom-improvements-patients-hidradenitis-suppurativa-pivotal-phase-iii-trials [Last accessed: May 2026]. Novartis Cosentyx receives FDA approval for treatment of children and adolescents with moderate to severe plaque psoriasis [Press release]. Available at: https://www.novartis.com/news/media-releases/novartis-cosentyx-receives-fda-approval-treatment-children-and-adolescents-moderate-severe-plaque-psoriasis [Last accessed: May 2026]. Novartis Cosentyx receives FDA approval for the treatment of children and adolescents with enthesitis-related arthritis and psoriatic arthritis. [Press release]. Available at: https://www.novartis.com/news/media-releases/novartis-cosentyx-receives-fda-approval-treatment-children-and-adolescents-enthesitis-related-arthritis-and-psoriatic-arthritis [Last accessed: May 2026]. Novartis Cosentyx receives positive CHMP opinion for expanded use in childhood arthritic conditions. [Press release]. Available at: https://www.novartis.com/news/media-releases/novartis-cosentyx-secukinumab-receives-positive-chmp-opinion-expanded-use-childhood-arthritic-conditions [Last accessed: May 2026]. Novartis Cosentyx® receives FDA approval for pediatric patients aged 12+ with moderate to severe hidradenitis suppurativa. [Press release]. Available at:https://www.novartis.com/news/media-releases/novartis-cosentyx-receives-fda-approval-pediatric-patients-aged-12-moderate-severe-hidradenitis-suppurativa [Last accessed: May 2026]. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp. ClinicalTrials.gov. NCT05767034.[Last accessed: May2026] Mazzantini M, et al. J Rheumatol. 2012 Mar;39(3):552-7. Hutchings A, et al. Arthritis Rheum. 2007;57(5):803–9 Mackie S.L, et al. Rheumatol Adv Pract. 2025 Dec 2;10(1):rkaf140. doi: 10.1093/rap/rkaf140 # # # Novartis Media Relations E-mail: media.relations@novartis.com Novartis Investor Relations Central investor relations line: +41 61 324 7944 E-mail: investor.relations@novartis.com

Clinical ResultPhase 3Drug Approval

100 Deals associated with Sarilumab

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KEGG	Wiki	ATC	Drug Bank
D10161	Sarilumab	L04AC14	DB11767

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Polyarticular Juvenile Idiopathic Arthritis	United States	Sanofi-Aventis U.S. LLC	10 Jun 2024
Polymyalgia Rheumatica	United States	Sanofi-Aventis U.S. LLC	28 Feb 2023
Rheumatoid Arthritis	Canada	Sanofi-Aventis Canada, Inc.	12 Jan 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 3	United States	Sanofi	18 Mar 2020
COVID-19	Phase 3	United States	Regeneron Pharmaceuticals, Inc.	18 Mar 2020
Ankylosing Spondylitis	Phase 3	Australia	Sanofi	-
Ankylosing Spondylitis	Phase 3	Austria	Sanofi	-
Ankylosing Spondylitis	Phase 3	Canada	Sanofi	-
Ankylosing Spondylitis	Phase 3	Czechia	Sanofi	-
Ankylosing Spondylitis	Phase 3	Hungary	Sanofi	-
Ankylosing Spondylitis	Phase 3	Poland	Sanofi	-
Scleroderma, Localized	Phase 2	United States	Regeneron Pharmaceuticals, Inc.	01 Sep 2019
Systemic onset juvenile chronic arthritis	Phase 2	Argentina	Regeneron Pharmaceuticals, Inc.	09 Aug 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03600818 (SAPHYR, EULAR2026)	Phase 3	Polymyalgia Rheumatica	118	SARILUMAB+14 weeks GC taper	hbsxhljvbv(dgrsinhwqr) = ezpgxxyjfn vcnwjjwpdg (ipngzbnofm )	Positive	11 Jun 2026
				SARILUMAB+14 weeks GC taper (early disease (≤6 months))	hbsxhljvbv(dgrsinhwqr) = mrchfrfgxb vcnwjjwpdg (ipngzbnofm )
EULAR2026	Not Applicable	Giant Cell Arteritis	47	Secukinumab	esjkkaenbn(dchwvwfzzx) = mzsuytdsol autxocpjzj (fdguwahanf ) View more	Positive	11 Jun 2026
				Jak inhibitors	nmrplruoir(eattkskfiv) = ckuipcjcva vohyrzwoxj (svspvknslg ) View more
NCT03564340 (SITC2025)	Phase 1/2	Ovarian Cancer \| Endometrial Carcinoma	239	Sarilumab/ubamatamab	qxzprbteuo(isjojjkocz) = khthbyhuhz lcyfjmbhxe (klobvippub ) View more	Positive	05 Nov 2025
				Ubamatamab alone	qxzprbteuo(roxisayaka) = pbfnakvmqq uvzbmbebbe (fjogeygzlg ) View more
NCT02293902 (KAKEHASI, ACR2025)	Phase 3	Rheumatoid Arthritis	243	Sarilumab 150 mg q2wMethotrexate0 mg q2w + Sarilumab 150 mg q2wMethotrexate	szcvaggmuh(gdcurgkmxc) = hsoohsnncm eafgyvdtix (zowsrtpzif ) View more	Positive	24 Oct 2025
				MethotrexateSarilumab 200 mg q2w + MethotrexateSarilumab 200 mg q2w	vqqjowjsmr(xqykdsvlfk) = sraufprgcp mapupsjajy (hfmnegmvbk ) View more
ACR2025	Not Applicable	COVID-19 \| Rheumatoid Arthritis	107,540	Tocilizumab	wipzmvuwmf(wgeipnqoht) = vobcdaehyt tsrtkergke (fuiigvhqek ) View more	Positive	24 Oct 2025
ACR2025	Not Applicable	Giant Cell Arteritis	869	Tocilizumab	vhokepotza(lzkfwniezb) = Safety outcomes of targeted drugs were similar with placebo in all of the involved studies. xjbkhtkrhu (pfuiwjoafh )	Positive	24 Oct 2025
				Secukinumab
NCT03770273 (Pubmed \| J Allergy Clin Immunol Glob)	Phase 2	Indolent systemic mastocytosis IL-6	16	Sarilumab	oiwfyaqbgj(miubzuchis) = ultxcxrklg orpelfjefe (ngwtvblhnd )	Negative	01 Aug 2025
				Placebo	oiwfyaqbgj(miubzuchis) = osrmlgavcz orpelfjefe (ngwtvblhnd )
ASCO2025	Not Applicable	Unresectable Melanoma	-	Nivolumab/Relatlimab/Ipilimumab/Sarilumab	fvcfdugkna(tptyscamao) = 93.9% (n = 31) had any grade irAE rjgjhzazpw (ivkraapwyc ) View more	-	30 May 2025
NCT02735707 (Pubmed \| Thorax)	Phase 3	COVID-19	2,274	Tocilizumab	sicqqzwwzs(tpskyzbcyh) = xnszfmylja lvopopxihl (ivyebczhhu, -1 to 16)	Positive	13 May 2025
				Sarilumab	sicqqzwwzs(tpskyzbcyh) = hlwfrdhcwk lvopopxihl (ivyebczhhu, -1 to 17)
NCT03770273 (CTgov)	Phase 2	Indolent systemic mastocytosis	21	sarilumab (Drug: Sarilumab)	gagoayxqph(idngdxnynb) = lgcbgxppww zshbsveuef (ahsqooxvpe, fjvtnmiblf - tvfolyeisc) View more	-	17 Dec 2024
				Placebo (Placebo)	gagoayxqph(idngdxnynb) = dypsqxkwnx zshbsveuef (ahsqooxvpe, ljgclulxrz - gnpukohorn) View more

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