The Polish multicentre observational (non-interventional) study aiming to collect data on the characteristic of patients with systemic lupus erythematosus and clinical outcomes of anifrolumab administered in the scope of routine clinical practice.

Start Date01 Jan 2025

Sponsor / Collaborator

AstraZeneca PLC

NCT06594068 / Not yet recruitingPhase 4

PRIMULA Lac (Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users): The AstraZeneca Lactation Study for Anifrolumab

Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users (PRIMULA Lac) is a Post Marketing Requirements (PMR) study designed to fulfill the FDA post-marketing requirements. The study will collect data about the presence of anifrolumab in human breast milk and serum (maternal and infant) among lactating individuals who receive anifrolumab therapeutically.

Start Date29 Nov 2024

Sponsor / Collaborator

AstraZeneca PLC

[+1]

NCT06659029 / Not yet recruitingNot Applicable

PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users): The AstraZeneca Pregnancy Study for Anifrolumab

PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users) is a prospective, observational cohort study designed to evaluate the association between anifrolumab exposure during pregnancy and subsequent adverse maternal, fetal, and infant outcomes. This study will fulfil an FDA post-marketing requirement.

Start Date29 Nov 2024

Sponsor / Collaborator

AstraZeneca PLC

[+1]

100 Clinical Results associated with Anifrolumab-FNIA

100 Translational Medicine associated with Anifrolumab-FNIA

100 Patents (Medical) associated with Anifrolumab-FNIA

227

Literatures (Medical) associated with Anifrolumab-FNIA

01 Dec 2025·Journal of Clinical Immunology

Normalized Interferon Signatures and Clinical Improvements by IFNAR1 Blocking Antibody (Anifrolumab) in Patients with Type I Interferonopathies

Article

Author: Horne, AnnaCarin ; Tan, Ziyang ; Mugabo, Constantin Habimana ; Wang, Jun ; Mikeš, Jaromír ; Goldbach-Mansky, Raphaela ; Lakshmikanth, Tadepally ; Alehashemi, Sara ; Kretzschmar, Genia ; Páez, Laura Piñero ; Gonzalez, Laura ; James, Anna ; Brodin, Petter ; Chen, Yang ; Johnsson, Anette ; Fischer, Marie ; Palmblad, Karin

AbstractPurposeA causal role of type-I interferons (IFN-I) in autoinflammatory type-I interferonopathies such as SAVI (STING–associated vasculopathy with onset in infancy) and CANDLE (chronic atypical neutrophilic dermatosis with lipodystrophy and elevated temperatures) is suggested by elevated expression of IFN-I stimulated genes (ISGs). Hitherto, the lack of specific inhibitors of IFN-I signaling has prevented the verification of a causal role for IFN-I in these conditions. Commonly used inhibitors of the JAK/STAT pathway exert broad effects on multiple signaling pathways leading to more general immunosuppression beyond IFN-I signaling.MethodsHere we show in four patients with SAVI and one patient with CANDLE syndrome that blockade of the IFNAR1 receptor (Anifrolumab) exerts an additive effect over JAK-inhibitor alone. In two patients with SAVI, monotherapy with Anifrolumab is sufficient to retain a suppressed IFN-I signature and clinical improvement.ResultsAnifrolumab normalizes IFN-I signature genes and relieves symptoms beyond what is typically achieved by a JAK-inhibitor (Baricitinib) alone in patients with type-I interferonopathies. In two patients Anifrolumab was used successfully as monotherapy. Addition of Anifrolumab enabled steroid tapering and cessation with reduced overall immunosuppression and lower risks of opportunistic infections and improved metabolic states and growth which is highly beneficial in these young patients.ConclusionThese results verify a causal role of IFN-I signaling in type-I Interferonopathies SAVI and CANDLE and suggests Anifrolumab as an important new treatment option in autoinflammatory diseases with elevated IFN-I induced gene expression.Genia Kretzschmar, Laura Piñero Páez, and Ziyang Tan are shared-first authors.Sara Alehashemi, AnnaCarin Horne, and Petter Brodin are co-senior author.

31 Dec 2024·Renal Failure

Effectiveness and safety of B cell-targeting biologics in the treatment of lupus nephritis: a systematic review and network meta‑analysis

Review

Author: Yang, Si-Qi ; Zhao, Xi ; Li, Man ; Wang, Yao-Guang

OBJECTIVESTo evaluate the effectiveness and safety of different B cell-targeting biological agents combining with standard of care in patients with lupus nephritis (LN).METHODSComprehensive literature searches were conducted using PubMed, Embase, Web of Science, and Central in the Cochran Library, spanning from inception to May 20th, 2024. Randomized control trials (RCTs) comparing rituximab (RTX), belimumab, ocrelizumab, obinutuzumab, and anifrolumab in LN were selected. The primary outcomes of interest were related to complete renal remission (CRR), and partial renal remission (PRR). Additionally, we delved into safety outcomes, examining the occurrence of serious adverse events (SAEs), infections, and the discontinuation rates due to adverse events.RESULTSA total of 6 RCTs with 1150 patients applying various B cell-targeting biological agents were included. Notably, ranking probability based on the surface under the cumulative ranking curve (SUCRA) indicated that obinutuzumab (SUCRA 85.2%) has the highest potential superiority in improving CRR, followed by belimumab, ocrelizumab. Regarding the improvement in PRR, obinutuzumab (SUCRA 83.0%) has the highest potential superiority. In terms of safety, with a focus on SAEs, infections, and the discontinuation rates due to adverse events, the results were: SUCRA-based ranking indicated that RTX (SUCRA 74.1%) had the highest probability of postponing SAEs, followed by belimumab and obinutuzumab. Concerning infection reduction, anifrolumab (SUCRA 78.7%) had the highest potential superiority. Safety events monitoring infection occurred better with RTX than with standard therapy (OR = 3.57, 95% CI 1.02, 12.66) and were statistically different. For the discontinuation rates due to adverse events, RTX (SUCRA 88.6%) demonstrated the highest potential superiority.CONCLUSIONSConcerning the effectiveness and safety outcomes, obinutuzumab, belimumab, and RTX plus standard of care may be superior to the current standard therapy as treatments for LN. This study protocol has been registered with PROSPERO, with a registration number of CRD42024548522.

01 Nov 2024·Lupus

Treatment of discoid lupus with lenalidomide and anifrolumab: Case report and review of the literature

Article

Author: Kang, Jun ; Centner, Connor S ; Timlin, Homa ; Sander, Inbal B ; Robertson, Nicole M

Discoid lupus erythematosus (DLE) is a devastating autoimmune disease with few therapies available. For patients with little to no symptom improvement with initial treatment, the literature surrounding further treatment options and their efficacy remains limited. Here we report a 46-year-old patient with lupus and refractory DLE, who failed numerous medications since her initial diagnosis in 2014. She had a robust response to lenalidomide with further improvement after adding anifrolumab (ANI), in conjunction with the standard of care hydroxychloroquine. Furthermore, she was able to taper off steroids without interval flares. The patient has not experienced any major infections since the initiation of treatment. No previous case reports describing outcomes of lenalidomide and ANI have been reported, yet the combinational approach has potential. Future clinical trials are needed to investigate the safety of the combination of lenalidomide and ANI in lupus patients with refractory DLE.

News (Medical) associated with Anifrolumab-FNIA

19 Nov 2024

·endpts.com

Biogen, UCB detail response rates in Phase 3 lupus trial after surprising success

Biogen and UCB on Tuesday shared an expanded dataset for their Phase 3 lupus program, which they said two months ago succeeded in a pivotal trial. In the 321-patient study, dapirolizumab pegol achieved a 49.5% response rate after 48 weeks when combined with the standard of care, compared to a 34.6% response rate from the standard of care alone. The difference between the trial arms was statistically significant with a p-value of 0.0110, Biogen said. The drug also succeeded on several secondary endpoints, including the rates at which patients tapered off their corticosteroids. There were 156 patients whose steroid use was above 7.5 mg per day, and 72.4% who took dapirolizumab pegol reduced their steroid use by week 48 to at most 7.5 mg per day, compared to 52.9% in the standard of care arm. The nominal p-value was 0.0404. Additionally, there was a higher rate of serious side effects in the standard of care group — 9.9% of patients who took dapirolizumab pegol reported side effects, compared to 14.8% in the standard of care group. Coming off the surprising topline win in September, the results help establish the case for continuing the program after it failed a Phase 2 study in 2018. At the time, dapirolizumab pegol had only been slated for one Phase 3 study instead of the requisite two needed for FDA approval. But with the success this week, planning for another trial is already in progress. Most of the details remain a secret, Biogen immunology chief Diana Gallagher told Endpoints News , but the study is expected to start before the end of the year and will run for another 48 weeks. “It’ll have a lot of similarities to what we’ve done before,” she said. In the Phase 3 study, researchers evaluated patients’ responses using a composite lupus symptom score called British Isles Lupus Assessment Group-based Composite Lupus Assessment, or BICLA for short. A higher response rate is associated with improved symptoms across all affected organs from baseline measurements, Biogen said. The standard of care for lupus has remained largely static over many decades, with the two most commonly used treatments being steroids: hydroxychloroquine and prednisone, according to Duke University rheumatologist and the study’s principal investigator Megan Clowse. But the former is typically used in only the most severe cases to prevent death, while the latter comes with “terrible” side effects. “The real unmet need for patients living with lupus is, number one, being able to get away from chronic prednisone use,” Clowse said. There have been two approvals since 2011 in lupus — one for GSK’s Benlysta, and another for AstraZeneca’s Saphnelo. They have helped somewhat, but their impact is still limited, Clowse said. If dapirolizumab pegol gets past the finish line, it will continue to help patients control their inflammatory symptoms for longer periods of time and won’t “require six horse pills every day,” she said, referring to steroids. Much of the recent buzz around lupus R&D has dealt with CD19-targeting CAR-T. Dapirolizumab pegol takes a different approach, inhibiting CD40L signaling, according to Biogen. It’s hard to make a direct comparison to studies because the only published CAR-T data in lupus are in academic settings from a small number of extremely sick patients, according to Biogen’s Gallagher. But there will still be space for dapirolizumab pegol in the market, given that CD40L inhibition is not a currently available option for lupus patients, she added. “It’s pretty profound,” Gallagher said. “You really hit B cells, T cells. It really resets immunologically, but it’s well-tolerated based on our available data.”

Clinical ResultPhase 3Phase 2ImmunotherapyCell Therapy

07 Oct 2024

·www.prnewswire.com

The Positive Topline Results From Phase III Study of UCB/Biogen's Dapirolizumab Pegol Brings a Ray of Hope in Systemic Lupus Erythematosus Therapeutic Space | DelveInsight

UCB and Biogen reported encouraging topline findings from the Phase III PHOENYCS GO trial, which assessed dapirolizumab pegol, a novel Fc-free anti-CD40L drug candidate, in individuals with moderate-to-severe SLE. The promising outcomes with dapirolizumab pegol signify significant advancements in creating treatments that can enhance the quality of life for individuals with lupus, a condition that continues to have considerable unmet medical needs, particularly impacting women. LAS VEGAS, Oct. 7, 2024 /PRNewswire/ -- Systemic lupus erythematosus is a long-lasting autoimmune disorder that can impact various areas of the body. Lupus arises when the immune system, typically responsible for defending against infections and illnesses, mistakenly targets the body's own tissues. This misguided response leads to inflammation and, in some instances, lasting damage to tissues, potentially affecting a wide range of organs including the skin, joints, heart, lungs, kidneys, blood cells, and brain. As per the estimates, the prevalence of systemic lupus erythematosus in the United States is approximately 500K cases in 2023. In females, prevalence rates are observed to be much greater than that of males, constituting more than 90% of the total prevalent cases in the US. In 2023, among the treated SLE patients, nearly 40% of patients became relapsed or refractory after the first line of therapy. The main goals of SLE treatment are to alleviate symptoms, prevent or reduce organ damage and disease flare-ups, minimize drug toxicity, and improve the patient's overall quality of life. The SLE treatment plan primarily includes antimalarial medications (like hydroxychloroquine), glucocorticoids (such as prednisone or similar), immunosuppressive drugs (including methotrexate, azathioprine, or mycophenolate), and biologics, in addition to nonsteroidal anti-inflammatory drugs (NSAIDs) for managing inflammation and pain. Biologics are specifically used for patients who do not respond to standard treatments or for those with severe, organ-threatening diseases. Currently, the biologics approved by the US FDA as adjunct therapies for SLE patients are BENLYSTA and SAPHNELO. In contrast, the use of rituximab for treating SLE is considered off-label. Learn more about the FDA-approved SLE drugs @ Drugs for Systemic Lupus Erythematosus Treatment BENLYSTA (belimumab) is a fully human monoclonal antibody that targets and inhibits BLyS (B-lymphocyte stimulator), a protein found at elevated levels in patients with systemic autoimmune diseases such as systemic lupus erythematosus and lupus nephritis. By binding to soluble BLyS, BENLYSTA prevents the prolonged survival of B cells, including autoreactive B cells, and reduces their differentiation into plasma cells that produce immunoglobulins. However, BENLYSTA does not directly bind to B cells. First approved by the US FDA in 2011, it is the only biologic therapy approved for the treatment of active SLE and LN in more than 50 years, including for pediatric patients. SAPHNELO (anifrolumab) is a fully human monoclonal antibody and the first of its kind, targeting subunit 1 of the type I interferon (IFN) receptor to inhibit type I IFN activity. Type I IFNs, including IFN-alpha, IFN-beta, and IFN-kappa, are cytokines that play a role in the inflammatory pathways associated with systemic lupus erythematosus. Most adults with SLE exhibit increased type I IFN signaling, which correlates with greater disease activity and severity. SAPHNELO has been approved for the treatment of SLE in over 60 countries, including the US, EU, and Japan, with ongoing reviews in additional regions. To know more about SLE treatment options, visit @ New Treatment for Systemic Lupus Erythematosus SLE pipeline possesses some drugs in mid and late-stage developments to be approved in the near future. The emerging landscape holds a diverse range of therapeutic alternatives for treatment, including Litifilimab (Biogen), Ianalumab (Novartis), Cenerimod (Idorsia/Viatris), Dapirolizumab pegol (UCB/Biogen), Telitacicept (RC18) (RemeGen), and others in different lines of treatment. The expected launch of these therapies shall further create a positive impact on the market. Discover which therapies are expected to grab major SLE market share @ Systemic Lupus Erythematosus Market Report Dapirolizumab pegol is a novel investigational treatment, consisting of a humanized, Fc-free antigen-binding (Fab') fragment conjugated with polyethylene glycol (PEG). It works by inhibiting CD40L signaling, which has been shown to reduce B cell activation, decrease autoantibody production, limit type 1 interferon (IFN) secretion, and suppress the activation of T cells and antigen-presenting cells (APCs). In September 2024, UCB and Biogen announced that the Phase III PHOENYCS GO trial achieved its primary goal, showing clinical improvements in patients with moderate-to-severe systemic lupus erythematosus. Additionally, key secondary endpoints, assessing disease activity and flare-ups, also demonstrated clinical improvements. Following the positive results from the PHOENYCS GO study, UCB and Biogen are launching a second Phase 3 trial of dapirolizumab pegol in 2024, named PHOENYCS FLY. Participants from the PHOENYCS GO study will continue to be monitored in a long-term open-label extension. Biogen is working on developing Litifilimab (BIIB059), an experimental humanized monoclonal antibody. This antibody specifically targets and binds to blood dendritic cell antigen 2 (BDCA2), a receptor found on plasmacytoid dendritic cells (pDCs). When BDCA2 is engaged, it inhibits the production of type I interferons (IFN-I) and other inflammatory molecules. BDCA2 is exclusively expressed on the surface of human pDCs. Litifilimab acts as an inhibitor of B-cell lymphocyte stimulator. Currently, Biogen is conducting Phase III clinical trials to evaluate its use for treating SLE. Ianalumab, developed by Novartis, is an antibody aimed at the B-cell activating factor receptor (BAFF-R). It is designed to inhibit BAFF-R signaling and deplete B cells through antibody-dependent cellular cytotoxicity. The drug is currently undergoing a Phase III clinical trial for systemic lupus erythematosus, with the company expecting to submit it for approval by 2027, according to a recent presentation. Cenerimod is an oral, once-daily tablet that acts as a highly selective modulator of the sphingosine-1-phosphate receptor 1 (S1P1). Although the exact cause of systemic lupus erythematosus is not fully understood, T and B lymphocytes are believed to be the primary immune cells involved in the disease's progression. These cells express the S1P1 receptor on their surface. In February 2024, Idorsia Pharmaceuticals formed a major global research and development partnership with Viatris to advance and commercialize two Phase III assets, selatogrel and cenerimod, on a global scale. Discover more about drugs for SLE in development @ Systemic Lupus Erythematosus Clinical Trials The anticipated launch of these emerging therapies for SLE are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the SLE market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for SLE is expected to grow from USD 3.2 billion in 2023 with a significant CAGR by 2034. This growth is mainly driven by ongoing clinical research and better diagnostic tools that might improve the prognosis of the disease. DelveInsight's latest published market report titled as Systemic Lupus Erythematosus Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the SLE country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The SLE market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total SLE Diagnosed Prevalent Cases Total SLE Diagnosed Prevalent Cases by Gender Total SLE Diagnosed Prevalent Cases by Age SLE Severity-Based Diagnosed Prevalent Cases Total SLE Treated Cases The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM SLE market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this SLE market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the SLE market. Also, stay abreast of the mitigating factors to improve your market position in the SLE therapeutic space. Related Reports Systemic Lupus Erythematosus Pipeline Systemic Lupus Erythematosus Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key myasthenia gravis companies, including Yake Biotechnology, UCB, Sorrento Therapeutics, SinoMab Bioscience Ltd, Shanghai Junshi Biosciences, Sareum, Sanofi, Roche, Rheos Medicine, Resolve, Provention Bio, Pfizer, Novartis, Neovacs, Merck, Medsenic, Landos Biopharma, Kezar Life Sciences, Kangpu Biopharmaceuticals, Janssen Research & Development, Janssen, InnoCare, ImmuPharma, I-MAB Biopharma, ILTOO, Idorsia Pharmaceuticals, Horizon Therapeutics, Genovax, Exinda Thearapeutics, Equillium, Eli Lilly and Company, Eisai, Daiichi Sankyo Company, Corestem, Corbus Pharmaceuticals, Citryll BV, Chipscreen Biosciences, Carna Bioscience, Bristol-Myers Squibb, Brickell Biotech, Boston Pharmaceuticals, Biogen, Athos Therapeutics, Asahi Kasei Pharma, Aria Pharmaceuticals, Antengene Therapeutics, Amgen, Alpine Immune Sciences, Akeso Biopharma, AbbVie, among others. Systemic Lupus Erythematosus Epidemiology Systemic Lupus Erythematosus Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted SLE epidemiology in the 7MM. Lupus Nephritis Market Lupus Nephritis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key lupus nephritis companies, including NOVARTIS, MORPHOSYS, ASTRAZENECA, ROCHE, KEZAR LIFE SCIENCES, ALEXION PHARMACEUTICALS, NOVARTIS, CABALETTA BIO, among others. Lupus Nephritis Pipeline Lupus Nephritis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key lupus nephritis companies, including Inflection Biosciences, Equillium, Roche, Horizon Therapeutics, BeiGene, Janssen Research & Development, ImmPACT Bio, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Drug Approval

26 Sep 2024

·www.fiercepharma.com

Roche looks to grow Gazyva's reach with phase 3 lupus nephritis win

Lupus nephritis is a potentially life-threatening kidney disease manifestation of systemic lupus erythematosus. After collecting a handful of oncology approvals since its first leukemia nod in 2013, Roche’s Biogen-partnered Rituxan successor, Gazyva, is chasing new horizons in active lupus nephritis.In a phase 3 study called REGENCY, a statistically higher proportion of lupus nephritis patients treated with biannual intravenous Gazyva doses and standard autoimmune disease therapy achieved complete renal responses at 76 weeks compared to those treated with standard therapy alone, Genentech reported Thursday. The trial enrolled a total of 271 participants.Lupus nephritis, a kidney disease-related manifestation of the most common lupus type, systemic lupus erythematosus (SLE), has no cure. Up to one-third of patients (currently some 1.7 million worldwide) will develop end-stage kidney disease within ten years, with dialysis and kidney transplants serving as their only available treatment options, according to Genentech. The potentially life-threatening disease primarily affects women, specifically women of color and women who are of “childbearing” age.“Since dialysis or transplants are often required for patients with advanced kidney disease, these findings could represent an important step forward for people living with this devastating disease,” Roche's chief medical officer and head of global development, Levi Garraway, M.D., Ph.D., said in a company release.The drug met certain secondary endpoints that looked at the proportion of patients who achieved complete renal responses with a successful reduction in corticosteroid use, plus proteinuric responses. But it fell short on secondary responses that looked at patients' mean change in estimated glomerular filtration rates, death or renal-related events and overall renal responses. Roche is sharing the data with regulatory agencies with a goal of making the potential new treatment available “as soon as possible,” the company said in its release. Gazyva is also being studied in children and adolescents with lupus nephritis and patients with membranous nephropathy, childhood-onset idiopathic nephrotic syndrome and SLE.The SLE market is currently populated by GSK’s blockbuster Benlysta and AstraZeneca’s newer offering Saphnelo. According to a recent report from Spherix Global Insights, the treatment landscape is poised for evolution with newer biologics angling to get in the field, including Biogen’s litifilimab, AbbVie’s Rinvoq and Bristol Myers Squibb’s Sotyktu. Gazyva works by attaching to CD20, a protein found on certain types of B cells. As lupus nephiritis is a B cell driven disease, targeting the disease-causing cells could protect the kidneys from further damage and potentially slow or prevent progression to end-stage kidney disease, according to Roche.Roche's Genentech and Biogen have a U.S. partnership for the drug, which scored its first approval in 2013 for chronic lymphocytic leukemia. Outside of its Gazyva collab, Biogen is working with UCB on another SLE candidate, dapirolizumab pegol.Biogen and UCB this week reported a successful phase 3 study for that prospect and are now set to begin a second phase 3 trial to support a potential approval.

Phase 3Clinical ResultDrug Approval

100 Deals associated with Anifrolumab-FNIA

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KEGG	Wiki	ATC	Drug Bank
D11082	Anifrolumab-FNIA	L04AA	DB11976

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Lupus Nephritis	AU	AstraZeneca Pty Ltd.	29 Mar 2022
Lupus Vasculitis, Central Nervous System	AU	AstraZeneca Pty Ltd.	29 Mar 2022
Systemic Lupus Erythematosus	US	AstraZeneca AB	30 Jul 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Systemic Lupus Erythematosus	Phase 3	CL	AstraZeneca PLC	09 Jun 2015
Systemic Lupus Erythematosus	Phase 3	KR	AstraZeneca PLC	09 Jun 2015
Systemic Lupus Erythematosus	Phase 3	CO	AstraZeneca PLC	09 Jun 2015
Systemic Lupus Erythematosus	Phase 3	GB	AstraZeneca PLC	09 Jun 2015
Systemic Lupus Erythematosus	Phase 3	BR	AstraZeneca PLC	09 Jun 2015
Systemic Lupus Erythematosus	Phase 3	AR	AstraZeneca PLC	09 Jun 2015
Systemic Lupus Erythematosus	Phase 3	TW	AstraZeneca PLC	09 Jun 2015
Systemic Lupus Erythematosus	Phase 3	PE	AstraZeneca PLC	09 Jun 2015
Systemic Lupus Erythematosus	Preclinical	IL	AstraZeneca PLC	09 Jun 2015
Systemic Lupus Erythematosus	Preclinical	NZ	AstraZeneca PLC	09 Jun 2015

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02794285 (TULIP-LTE, Pubmed \| Mod Rheumatol) Manual	Phase 3	Systemic Lupus Erythematosus	-	Anifrolumab 300 mg	(adbdyngkqr) = obygneysds ongcmlxjqq (lksesknsbn ) View more	Positive	06 Jul 2024
				Placebo	(adbdyngkqr) = cbgjcqusrg ongcmlxjqq (lksesknsbn ) View more
NCT02794285 (EULAR2024) Manual	Phase 3	Systemic Lupus Erythematosus	536	Anifrolumab 300mg	(qvgadwqbrk) = yktjzncshi gudhvuktry (rgjxlnxdlt ) View more	Positive	05 Jun 2024
				Placebo	(qvgadwqbrk) = ozjgadzceu gudhvuktry (rgjxlnxdlt ) View more
EULAR2024	Not Applicable	Systemic Lupus Erythematosus anti-double-stranded DNA antibodies \| anti-phospholipid syndrome \| anti-nuclear antibodies	14	Anifrolumab	qmkawvfwlo(ihzgthuejf) = a decrease in CRP levels ebhuqykauz (vbzlfjfgag ) View more	Positive	05 Jun 2024
EULAR2024	Not Applicable	Systemic Lupus Erythematosus type I interferon (IFN) receptor	13	Anifrolumab	(kuxqxokijd) = urauiiuwma ktbnclxjoa (dzfzgkxsnk, 2.0 - 2.5) View more	Positive	05 Jun 2024
NCT02794285 (TULIP-1/-2/-LTE, EULAR2024)	Phase 3	Systemic Lupus Erythematosus	369	Anifrolumab 300 mg	tifxdfswrt(lquugrybmm) = vqzhpdvqix jehcmtegqh (tzjxuhqggq )	Positive	05 Jun 2024
				Placebo	tifxdfswrt(lquugrybmm) = ltkadudamy jehcmtegqh (tzjxuhqggq )
NCT01438489 \| NCT02446912 \| NCT02446899 (MUSE \| TULIP-1 \| TULIP-2, EULAR2024)	Phase 2/3	Systemic Lupus Erythematosus	438	Anifrolumab	tllcbntsdq(xgkrbcqxaf) = krkhgstztp ryeatwinsc (ravjhrcblf )	Positive	05 Jun 2024
EULAR2024	Not Applicable	Systemic Lupus Erythematosus	65	Anifrolumab	pjwtucoarr(xzondeutcs) = The incidence of adverse events were fewer in the anifrolumab group (p=0.0012), especially in infections (p=0.0169) ilrrpyuiyx (fuprtmhqwp )	Positive	05 Jun 2024
				Anifrolumab (Standard of Care (SoC))
ISN WCN2024	Not Applicable	APOL-1 gene	11	Anifrolumab 300 mg	lnswffcgex(jffnpwuiwy) = UP/Cr was significantly reduced (P<0.05) for both nephrotic and non-nephrotic patients. Both APOL-1 negative patients and those with a single at-risk allele demonstrated a reduction in UP/Cr tuuzfmoejh (nfyjohqfzo ) View more	Positive	01 Apr 2024
ACR2023	Not Applicable	Systemic Lupus Erythematosus	-	Anifrolumab	jamnfynxbs(wtrtlpvbch) = gnvhokezcr rsuommagfr (xeeufkitei )	-	13 Nov 2023
TULIP-1/TULIP-2 (EULAR2023)	Phase 3	-	369	Anifrolumab 300 mg	gepzizfvvj(jabpzqacfw) = bmgxuuzzfo hztcvlpeaz (ezjrveykke )	Positive	31 May 2023
				Placebo	gepzizfvvj(jabpzqacfw) = jdkhwqmnlt hztcvlpeaz (ezjrveykke )

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