Anifrolumab pdufa. - Mechanism of Action & Protocol.

Anifrolumab pdufa Anifrolumab is a monoclonal antibody that targets the type I IFN receptor subunit 1. Extensive real-world use is now going to generate data required to gain experience on the type of patients who benefit the most from the drug, and the exact positioning of anifroluma … A BLA for anifrolumab was submitted to the FDA for the treatment of SLE in November 2020, and the PDUFA action date is 5 July 2021. There are many unmet needs in the treatment of SLE. Methods Multicenter retrospective study involving 9 Italian SLE referral centers participating in a compassionate use program for the use of ANI in active adult SLE patients in whom all the available treatment choices failed, were not tolerated or contraindicated. Anifrolumab was 1 of 3 anti-type-1 interferon agents under investigation as a potential treatment for systemic lupus erythematosus (SLE). Jul 19, 2025 · Anifrolumab for refractory lupus erythematosus panniculitis in systemic lupus erythematosus Case series of anifrolumab for treatment of cutaneous lupus erythematosus and lupus-related mucocutaneous manifestations in patients with SLE Sep 23, 2024 · Understanding the precise mechanisms of monogenic autoinflammatory diseases provides crucial insights into the complex pathophysiology of more common multifactorial diseases, while treatments developed for these prevalent conditions hold promising potential to tackle rare genetic disorders. , November 1, 2021 – New subgroup analyses from the TULIP Phase III clinical trial program showed SAPHNELO (anifrolumab), a first-in-class type I interferon antagonist, in addition to standard therapy, resulted in a greater reduction in systemic lupus erythematosus (SLE) disease activity regardless of disease duration, standard therapy type and prior treatment, compared to Mar 21, 2024 · SAPHNELO (anifrolumab) is a first-in-class, fully human monoclonal antibody that binds to subunit 1 of the type I interferon (IFN) receptor, blocking the activity of type I IFN. Saphnelo is also referred to by its drug name, anifrolumab-fnia. Anifrolumab-fnia is likely to be prescribed by rheumatologists familiar Dec 16, 2021 · Saphnelo is given to patients who have antibodies against their own cells (autoantibodies) and whose disease is still moderate to severe despite standard treatment. This web site is intended to help healthcare professionals practicing in the US and AstraZeneca authorized persons find scientifically Learn about SAPHNELO® (anifrolumab-fnia), a treatment for adults with moderate to severe SLE on other lupus medicines. The PDUFA date for anifrolumab is September 30, 2021, according to the Antibody Society. The increased risk for potentially fatal infections and hypersensitivity and infusion related reactions are similar to another approved targeted immunosuppressive therapy for SLE. Oct 10, 2024 · Anifrolumab (Saphnelo) is used for moderate to severe systemic lupus erythematosus (SLE). Conclusion: Anifrolumab effectively suppressed the IFN-1 signature/score in all patients, including in SAVI pts; this was associated with improved serum CRP and ESR in the context of tapering doses of baricitinib and corticosteroids. Sesen Bio and Qilu Pharmaceuticals are developing oportuzumab monatox, a recombinant Saphnelo (anifrolumab-fnia) is proven for the treatment of moderate to severe systemic lupus erythematosus (SLE) when all of the following criteria are met: For initial therapy, all of the following: Diagnosis of moderate to severe systemic lupus erythematosus, without severe active central nervous system lupus or severe active lupus nephritis; and 3 days ago · After being all-but written off a year ago, AstraZeneca’s anifrolumab has been reborn with new data that suggest it could help to end a drought in treatments for autoimmune disease systemic Aug 2, 2021 · Additionally, subcutaneous anifrolumab is being evaluated in a Phase III trial in SLE. 9% sodium chloride infusion solution (9 mg/ml), Saphnelo is given as an infusion over 30 minutes using an infusion tubing containing a sterile 0. We aimed to Jan 16, 2025 · In recent years, the development of novel therapeutics for systemic lupus erythematosus (SLE) has grown due to significant advances in research. Anifrolumab is a fully human immunoglobulin G1 kappa monoclonal antibody that inhibits the signalling of type I interferon receptor subunit 1, thereby inhibiting the activity of all type I interferons. AstraZeneca will continue to explore Saphnelo for other indications including trials in lupus nephritis (LN) and cutaneous lupus erythematosus (CLE), myositis and pediatric patients with SLE. It could antagonize the activity Dec 23, 2024 · A prospective single-centre study 12 of anifrolumab in refractory SLE and a case series of four patients 13 with CLE and non-specific mucocutaneous manifestations of SLE study provide real-world insights into the use of anifrolumab in different refractory CLE subtypes and SLE-associated dermatological manifestations. At baseline, at 1, 3, 6, 9 and 12 months of Medscape - Systemic lupus erythematosus dosing for Saphnelo, anifrolumab-fnia (anifrolumab), frequency-based adverse effects, comprehensive interactions, contraindications, pregnancy & lactation schedules, and cost information. Jun 10, 2021 · A BLA for anifrolumab was submitted to the FDA for the treatment of SLE in November 2020, and the PDUFA action date is 5 July 2021. SLE is the most common form of lupus. Methods: Patients received intravenous anifrolumab 900 mg for the first 3 doses followed by Abstract Background: In the TULIP-1 and TULIP-2 phase 3 trials, anifrolumab treatment was associated with clinical efficacy and clinically meaningful improvements in multiple patient-reported outcomes over 52 weeks in patients with moderate-to-severe systemic lupus erythematosus (SLE). We evaluated the safety and tolerability of anifrolumab using data pooled Anifrolumab substantially reduced disease activity compared with placebo across multiple clinical end points in the patients with moderate-to-severe SLE. Saphnelo is the first biologic for SLE approved in Europe with an indication that is not restricted to patients with a high degree of Feb 4, 2020 · The TULIP-2 trial of anifrolumab, a monoclonal antibody against type I interferon receptor (IFNAR), in active systemic lupus erythematosus (SLE) has met its primary end point. - Mechanism of Action & Protocol. The purpose of this work is assessing the efficacy of Anifrolumab in active non-renal SLE, focusing on cutaneous and musculoskeletal This is a Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of anifrolumab versus placebo as added to SOC (consisting of MMF and glucocorticoids) in adults with active proliferative Class III or Class IV LN (both with or without concomitant Class V). Methods Patients with moderate to severe Apr 8, 2025 · In line with the clinical profile of anifrolumab in the TULIP-2 study, the efficacy of anifrolumab was shown in Japanese SLE patients with serological manifestations achieving a BICLA response, and with tapered GC dose or sustained GC doses of ≤7. 2 or 0. The findings offer critical safety information for clinicians prescribing anifrolumab for the treatment of SLE, aiding in the optimization of patient management and treatment decision-making. Information for patients and caregivers about Anifrolumab-fnia (Saphnelo), such as usages, common dosages, safety tips, and possible side effects. Aug 17, 2023 · The recently approved type I interferon receptor antagonist anifrolumab is a new treatment option for this historically underserved patient population. 48 next » Visible columns Record category Entry ID Status check date INN Drug code (s) Brand name MAb sequence source General Molecular Category Format, general category Format details Target (s) Isotype (Fc) Light chain isotype Linker Ave. Anifrolumab is a fully human immunoglobulin G1 κ monoclonal antibody specific for subunit 1 of the type I interferon (IFN) α receptor. Aug 27, 2025 · Warnings Before taking Dosage Side effects Interactions FAQ What is Saphnelo? Saphnelo (anifrolumab) is a prescription medicine used for moderate to severe systemic lupus erythematosus (SLE or lupus) as an add-on treatment to other lupus medicines. 22 micrometer in-line filter with low protein binding. Anifrolumab is indicated for treating adult patients with moderate to severe systemic lupus erythematosus receiving standard therapy. DAR Conjugated moiety Description Discovery method Anticipated events Most advanced stage of development Status Start of clinical phase Start of first Aug 23, 2023 · NCT02547922. Anifrolumab (anifrolumab-fnia; Saphnelo^™) is a monoclonal antibody antagonist of the type 1 interferon receptor (IFNAR). Nov 11, 2019 · Type I interferons are involved in systemic lupus erythematosus (SLE) pathogenesis. Consider the risks and benefits of administering anifrolumab-fnia in patients who have chronic infections or are at high risk for developing infections before starting therapy. The molecular weight is approximately 148 kDa. It is used to treat systemic lupus erythematosus (SLE). It works by slowing down an overactive immune system, which reduces inflammation and other symptoms of lupus. Anifrolumab is being developed by AstraZeneca (under license from Medarex, now Bristol-Myers Squibb) for the treatment of autoimmune disorders, including SLE and lupus nephritis. May 21, 2025 · PV248 / #665 Poster Topic: AS24 - SLE-Treatment Background/Purpose Anifrolumab (ANI), a human monoclonal antibody targeting the type I interferon receptor subunit 1 (IFNAR1), blocks the activity of this interferon and has shown efficacy in reducing disease activity in systemic lupus erythematosus (SLE). Adjunctive anifrolumab-fnia therapy may be useful for improving global, skin, and joint symptoms, glucocorticoid-sparing effects, and reducing flares in patients with active, moderate to severe SLE despite standard therapy, excluding patients who have severe lupus nephritis or central nervous system disease. The May 21, 2025 · PV279 / #686 Poster Topic: AS24 - SLE-Treatment Background/Purpose Anifrolumab (ANI), an anti-type 1 interferon-alpha receptor antibody, has recently been approved for SLE treatment, following the positive results in 2 phase III randomized controlled trials. “This is the first May 6, 2023 · The type I interferon (IFN) signaling pathway is implicated in the pathogenesis of systemic lupus erythematosus (SLE). [5][7] It binds to the type I interferon receptor, blocking the activity of type I interferons such as interferon-α and interferon-β. 1,2 A few case reports have suggested an efficacy of anifrolumab in refractory CLE. 1 The approval by the Food and Drug Administration (FDA) was based on efficacy and safety data from the Saphnelo clinical development programme, including two TULIP Phase III trials and the SAPHNELO® (anifrolumab-fnia) injection, for intravenous use, is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy. What is Anifrolumab? Anifrolumab is a type of medicine called a biological disease-modifying antirheumatic drug (bDMARD). Aug 7, 2024 · Anifrolumab-fnia is a type I interferon (IFN) receptor antagonist, immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that is produced in mouse myeloma cells (NS0) by recombinant DNA technology To investigate long‐term safety and tolerability of anifrolumab, a human monoclonal antibody to the type I interferon (IFN) receptor subunit 1, in patients with moderate‐to‐severe systemic lupus erythematosus (SLE). Initial in vivo studies observed higher levels of serum interferon (IFN) in patients with autoimmune disease as opposed to those of healthy controls. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for anifrolumab-fnia and any potential adverse effects on the breast-fed child from anifrolumab-fnia or from the underlying maternal condition. Anifrolumab is a human monoclonal antibody to the type I IFN receptor subunit 1, which blocks the action of type I IFNs. S. If approved, anifrolumab would be the first treatment for SLE to Spotlight on anifrolumab and its potential for the treatment of moderate-to-severe systemic lupus erythematosus: evidence to date Anifrolumab (anifrolumab-fnia; SaphneloTM) is an immunoglobulin gamma 1 kappa (IgG1κ) monoclonal anti-body antagonist of the type 1 IFN receptor (IFNAR) [3]. License No. 3 However, its real Abstract Chronic activation of the type I interferon (IFN) pathway plays a critical role in systemic lupus erythematosus (SLE) pathogenesis. “I think this drug approval for lupus represents an important milestone,” says Mary K. 18,19 Type I IFNs, such as IFN-alpha, IFN-beta and IFN-kappa, are cytokines involved in regulating the inflammatory pathways implicated in SLE. It is a monoclonal antibody. In a few subgroups, small sample sizes limited conclusions from being drawn regarding the treatment benefit with anifrolumab. How Saphnelo® Works: Real-time biotech investing insights including FDA Calendar, PDUFA Calendar, Biotech earnings calendar, biotech hedge fund and much more. Anifrolumab is a type I interferon (IFN) receptor antagonist, a human monoclonal antibody. [medical citation needed] Dec 18, 2019 · Anifrolumab, a human monoclonal antibody to type I interferon receptor subunit 1 investigated for the treatment of systemic lupus erythematosus (SLE), did not have a significant effect on the prima This study evaluates the efficacy and safety of subcutaneous anifrolumab in adults with moderate-to-severe systemic lupus erythematosus despite standard therapy. Clinical trials have shown that anifrolumab is effective in cutaneous lupus erythematosus (CLE) associated with SLE. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting, after receiving this medicine. Aug 2, 2021 · AstraZeneca’s Saphnelo (anifrolumab-fnia) has been approved in the US for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy. Jan 26, 2023 · Saphnelo® (anifrolumab-fnia) is a monoclonal antibody used for the treatment of systemic lupus erythematosus (SLE)in adults who are receiving standard therapy. Objective: To characterise the safety and efficacy of anifrolumab in active lupus nephritis (LN) through year 2 of the phase II randomised, double-blind Treatment of Uncontrolled Lupus via the Interferon Pathway (TULIP)-LN trial (NCT02547922) of 2 anifrolumab dosing regimens versus placebo. 761123Orig1s000 MULTI-DISCIPLINE REVIEW Summary Review Office Director Cross Discipline Team Leader Review Clinical Review Non-Clinical Review Statistical Review Clinical Pharmacology Review BLA 761123 Multi-disciplinary Review and Evaluation Saphnelo (anifrolumab-fnia) for adults with SLE (anifrolumab-fnia) InjectionThe information provided on this site is intended for use by healthcare professionals practicing in the US. Feb 1, 2025 · Anifrolumab-fnia may cause infusion reactions, which can be life-threatening and require immediate medical attention. Anifrolumab Adult Medication This information from Lexicomp ® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider. We investigated the mechanistic and pharmacological properties of anifrolumab, a fully human, effector-null, anti-type I interferon (IFN) alpha receptor 1 (IFNAR1) monoclonal antibody in development for SLE. In a phase II trial with a Japanese cohort, 100, 300, or 1,000 mg of the drug was used in patients every 4 weeks, and nonlinear pharmacokinetics was observed (Morehouse et al. Includes Anifrolumab side effects, indications, MOA, reviews, and more. Monitor closely and consider interrupting anifrolumab-fnia in patients who develop new infections while appropriate anti-infective therapy is administered. In a phase IIb study of adults with moderate to severe SLE, anifrolumab treatment demonstrated substantial Feb 2, 2024 · Among patients with at least six swollen joints, more patients in the anifrolumab group than in the placebo group had a 50% or more reduction from baseline to week 52 in swollen joint count (99 [57%] of 174 vs 92 [46%] of 200), but the difference between groups was not significant for 50% or more reduction in tender joint count. Jul 1, 2025 · A guide to prescribing anifrolumab-fnia in adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy. Jul 21, 2025 · This study provides valuable safety data on the real-world application of anifrolumab, confirming known AEs and revealing additional potential risks. Saphnelo is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), receiving Jan 30, 2025 · Learn about the efficacy and clinical study results of SAPHNELO® (anifrolumab-fnia) intravenous injection in patients with moderate-to-severe SLE who are receiving standard therapy. See how SAPHNELO works. The safety profile of anifrolumab was similar across subgroups. After dilution with 0. Anifrolumab is a promising therapeutic option for patients with SLE, currently authorized for moderate-to-severe SLE. This case report The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User Fee Act of 2022 (PDUFA VII), authorizes FDA to assess and collect fees for prescription drug Apr 5, 2018 · Objective We investigated the mechanistic and pharmacological properties of anifrolumab, a fully human, effector-null, anti-type I interferon (IFN) alpha receptor 1 (IFNAR1) monoclonal antibody in development for SLE. Crow, MD, Benjamin M. [1] Jan 30, 2025 · Learn about SAPHNELO® (anifrolumab-fnia) dosing and administration recommendations, and instructions for preparation and administration. Methods IFNAR1 surface expression and internalisation on human monocytes before and after exposure to anifrolumab were assessed using confocal microscopy and flow cytometry. The efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Two phase 3 studies (TULIP-1 and TULIP-2) and a phase 2b study (MUSE) provide substantial evidence for the efficacy and safety of Detailed description This is a Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of anifrolumab versus placebo as added to SOC (consisting of MMF and glucocorticoids) in adults with active proliferative Class III or Class IV LN (both with or without concomitant Class V). Anifrolumab, sold under the brand name Saphnelo, is a monoclonal antibody used for the treatment of systemic lupus erythematosus. SAPHNELO (anifrolumab-fnia) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow, solution for intravenous use. Saphnelo helps reduce the body's overactive immune and inflammatory response, which improves FAQs Do you have questions about SAPHNELO? Remember, your healthcare provider is always your first and best option to answer any treatment questions you may have, but you can read through some common questions about SAPHNELO here on this page. 20-25 The majority of Anifrolumab from AstraZeneca, which would be a first-in-class type I interferon inhibitor, is one of the most promising investigational drugs for treating systemic lupus erythematosus (SLE). Anifrolumab Also an anti-cytokine therapy drug, anifrolumab is an anti IFN type 1α receptor antibody. Food and Drug Administration approved anifrolumab (Saphnelo) in early August — the first new drug approved for SLE in 10 years. The dissemination of this information may be subject to different medical and regulatory requirements in other countries. Feb 16, 2022 · AstraZeneca’s Saphnelo (anifrolumab) has been approved in the European Union as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite receiving standard therapy. A Study to evaluate the PK, PD, efficacy, and safety of Anifrolumab in children with moderate to severe active SLE The purpose of this multicenter, randomized, placebo-controlled and double-blind study is to evaluate the efficacy and safety of subcutaneous anifrolumab compared with placebo on the overall disease activity in participants with moderate to severe Idiopathic Inflammatory Myopathies (IIM) [polymyositis (PM) or dermatomyositis (DM)] while receiving standard of care (SoC) treatment. It is currently in phase II efficacy and safety studies to evaluate its long-term safety. To assess the efficacy and safety of anifrolumab, a type I interferon (IFN) receptor antagonist, in a phase IIb, randomized, double‐blind, placebo‐controlled study of adults with moderate‐to‐severe systemic lupus erythematosus (SLE). Use of SAPHNELO is not recommended in these Jan 30, 2025 · Find out how SAPHNELO® (anifrolumab-fnia) affects IFN-1 activity. . Nov 1, 2021 · WILMINGTON, Del. We previously reported the first description of off-label use of anifrolumab for DM in a patient with recalcitrant cutaneous juvenile DM, finding 78% improvement in the Cutaneous Dermatomyositis Area and Severity Index activity (CDASI-A) score within 2 months of anifrolumab In phase II and III trials, anifrolumab, a human monoclonal antibody that binds type I interferon receptor subunit 1, has shown efficacy in adults with moderate to severe SLE. Here, we investigated the immunomodulatory mechanisms of anifrolumab using longitudinal transcriptomic and proteomic analyses of the 52-week, randomised, phase 3 TULIP-1 and TULIP-2 trials. Anifrolumab blocks the activity of type I interferon. Anifrolumab can be used in systemic lupus erythematosus (SLE) research. Saphnelo is believed to work by dampening immune system signaling that can cause inflammation. Jan 30, 2025 · SAPHNELO® (anifrolumab-fnia) intravenous infusion is a treatment for adults with moderate to severe systemic lupus erythematosus who are receiving standard lupus treatment. The entirety of the anifrolumab pharmacokinetics and pharmacodynamics data combined with the low immunogenicity has demonstrated that, overall, the approved anifrolumab 300 mg IV every four weeks regimen provides sufficient drug exposure to maximize benefit, while maintaining a tolerable safety profile in SLE patients who are receiving standard Mar 3, 2023 · Anifrolumab, which is a human monoclonal antibody that binds type I interferon receptor subunit 1,1 has been approved for the treatment of systemic lupus erythematosus (SLE). Rosen Chair in Immunology and Inflammation Research We would like to show you a description here but the site won’t allow us. As an interferon (IFN) receptor antagonist, Saphnelo® blocks type I interferon signaling, a key driver of inflammation and immune dysfunction in lupus. Anifrolumab Injection What is this medication? ANIFROLUMAB (an i frol ue mab) treats certain types of lupus. Despite recent advances, remission and low disease activity By Jill Tyrer People living with systemic lupus erythematosus (SLE) have a new drug option. Saphnelo is a type of biologic treatment known as a type 1 interferon receptor antagonist. Anifrolumab 300 mg monthly was then begun (and intravenous immunoglobulin discontinued), chosen based on its rapid effect when used for cutaneous lupus, 2 and its promising safety data—including malignancy rate comparable to placebo—as described in a long-term extension safety study. If approved, anifrolumab would be the first treatment for SLE to Oct 20, 2016 · Anifrolumab is a monoclonal antibody that inhibits type 1 interferon receptors, indicated in the treatment of moderate to severe systemic lupus erythematosus. How do I take it? We have approved your BLA for Saphnelo (anifrolumab-fnia) effective this date. The U. Anifrolumab is approved in several countries for patients with moderate to severe SLE receiving standard therapy. Jun 24, 2024 · Objective To report the real-world experience on the use of ANI in refractory SLE. SAPHNELO® (anifrolumab-fnia) infusion is a treatment for adults with moderate to severe systemic lupus erythematosus who are receiving standard lupus medications. The approved dosing regimen of anifrolumab is a 300-mg dose administered Jan 2, 2021 · Anifrolumab mode of action, pharmacodynamics, and pharmacokinetics Anifrolumab (previously MEDI-546) is a fully human IgG1κ monoclonal antibody that blocks the action of all type I IFNs by binding to subunit 1 of the type I IFNAR (IFNAR1) with high affinity and specificity [31]. If approved, anifrolumab would be the first treatment for SLE to be approved by the FDA since its 2011 approval of the BLyS-specific mAb belimumab (Benlysta; GlaxoSmithKline). 2059. Anifrolumab is not recommended in patients with severe active lupus nephritis or severe active central nervous system lupus, as the drug's efficacy has not been evaluated in these patient populations. Biological therapies such as belimumab and anifrolumab have gained prominence and are recommended by international guidelines for managing moderate to severe SLE, particularly in patients unresponsive to conventional therapies and in severe cutaneous We would like to show you a description here but the site won’t allow us. You are hereby authorized to introduce or deliver for introduction into interstate commerce, Saphnelo under your existing Department of Health and Human Services U. Anifrolumab is indicated as add-on treatment for moderate to severe active systemic lupus erythematosus. Systemic lupus erythematosus (SLE) is a chronic autoimmune disease, and type I interferon plays an important role in its pathogenesis. It is being developed by AstraZeneca (under license from Medarex, now Bristol-Myers Squibb) for the treatment of autoimmune disorders, including systemic lupus erythema … Jun 30, 2024 · PharmaDepthPDUFA Dates Introduction Anifrolumab is a type I interferon (IFN) receptor 1 (IFNAR1) blocking antibody approved for treating patients with systemic lupus erythematosus (SLE). Saphnelo contains the active substance anifrolumab. The Division of Risk Management (DRM) has determined that a REMS is not needed to ensure the benefits of anifrolumab-fnia outweigh its risks. SAPHNELO contains anifrolumab-fnia at a concentration of 150 mg/mL in a single-dose vial. , 2014). Apr 12, 2025 · Anifrolumab is intended for intravenous use. Here, we sought to confirm the efficacy of anifrolumab versus placebo in a phase 3 trial of adult patients with SLE and Anifrolumab is a prescription medication used for the treatment of moderate-to-severe systemic lupus erythematosus (SLE). Real-world evidence is critical to understanding its utilization and outcomes. We would like to show you a description here but the site won’t allow us. In phase 3 trials, a higher percentage of patients on anifrolumab achieved remission, as defined by the Definition Of Remission In SLE (DORIS), and LLDAS compared with placebo. In a phase 2 trial, anifrolumab, a human monoclonal antibody to type I interferon receptor subunit 1, suppressed interferon gene signatures and substantially reduced SLE disease activity. Conclusions: Overall, this study supports the consistent efficacy and safety of anifrolumab across a range of patients with moderate-to-severe SLE. Dermatomyositis (DM) and antisynthetase syndrome are rare autoimmune disorders within the spectrum of inflammatory myopathies, typically characterized by cutaneous and muscular inflammation along with systemic manifestations. Aug 12, 2024 · Anifrolumab is a type I interferon (IFN) receptor antagonist approved for the treatment of systemic lupus erythematosus. Anifrolumab is a new strategy for the treatment of systemic lupus erythematosus. Patients Aug 23, 2023 · The recently approved type I interferon receptor antagonist anifrolumab is a new treatment option for this historically underserved patient population. 3 Anifrolumab administration resulted in marked skin Nov 1, 2024 · The article by Tani et al, “Anifrolumab in Refractory Systemic Lupus Erythematosus: A Real-World, Multicenter Study,”1 evaluates the efficacy of anifrolumab (ANI) in patients with systemic lupus erythematosus (SLE) who failed to respond to other treatments, including biologics. IFNAR1 surface expression and A BLA for anifrolumab was submitted to the FDA for the treatment of SLE in November 2020, and the PDUFA action date is 5 July 2021. This 3‐year, multinational, A BLA for anifrolumab was submitted to the FDA for the treatment of SLE in November 2020, and the PDUFA action date is 5 July 2021. 5 mg/day. auwqh mcxmqlz kuej qvbt vnujef sptsez cfqs iaji ixiue teptt lbab bqond yytpa qzkkvmg urpqg