Lisraya (brepocitinib) / Pfizer, Priovant Therap - LARVOL DELTA

Efficacy and Safety of Brepocitinib in Cutaneous Sarcoidosis: Results from the Randomized, Double-Blind, Multicenter, Placebo-Controlled, Phase II (BEACON) Trial (ACR Convergence 2026) - P2/3 | "BEACON represents the first positive, randomized, placebo-controlled trial of a targeted therapeutic in CS. Oral brepocitinib 45 mg achieved rapid, significant, and clinically meaningful improvements in disease activity and PROs with an acceptable safety profile. A global Phase 3 trial of brepocitinib for the treatment of CS will be initiated in 2026.[1] Noe MH, et al."

Clinical • P2 data • Immunology • Infectious Disease • Inflammation • Sarcoidosis • JAK1 • TYK2

Brepocitinib Improves Patient-Reported Physical Disability, Pain, and Fatigue in Dermatomyositis Patients at One Year (ACR Convergence 2026) - No abstract available

Clinical • Dermatomyositis • Fatigue • Immunology • Myositis • Pain

Brepocitinib Demonstrates Consistent Clinical Responses Along With Reduced Oral Corticosteroid Use in Dermatomyositis Patients With Interstitial Lung Disease: Results From the Phase 3 VALOR Trial (ACR Convergence 2026) - No abstract available

Clinical • P3 data • Dermatomyositis • Immunology • Interstitial Lung Disease • Myositis • Pulmonary Disease • Respiratory Diseases

Brepocitinib Demonstrates Consistent Benefit on Combined Measures of Clinical Response and Sustained Corticosteroid Tapering in Dermatomyositis Patients at One Year (ACR Convergence 2026) - No abstract available

Clinical • Dermatomyositis • Immunology • Myositis

Brepocitinib Achieves Rapid and Sustained Control of Cutaneous Disease Activity, Itch, and Skin-Related Quality of Life in Dermatomyositis: Results From the Phase 3 VALOR Trial (ACR Convergence 2026) - No abstract available

HEOR • P3 data • Dermatomyositis • Immunology • Myositis

Achievement of Low Disease Activity and Remission in Dermatomyositis Patients Treated with Brepocitinib: Analyses from the Phase 3 VALOR Trial (ACR Convergence 2026) - "LDA was defined as PtGA-VAS < 4, PhGA-VAS < 4, and OCS dose ≤ 5 mg/d prednisone-equivalent, reflecting clinically meaningful disease control with low background OCS exposure. Brepocitinib 30 mg was associated with clinically meaningful benefits on global disease activity, corticosteroid tapering, and functional disability. These findings support the potential for brepocitinib to induce proposed states of LDA and clinical remission and may inform future remission-oriented treatment strategies in DM."

Clinical • P3 data • Dermatomyositis • Immunology • Myositis • TYK2

Precision Over Prednisone: Mechanism-Based Therapy for Dermatomyositis in the Modern Era (ACR Convergence 2026) - "Learning Objectives: • Using a case-based approach, Explain the rationale for use of immunoglobulin therapy in myositis, with special emphasis in conditions where clinical trial data is available to guide its implementation • Identify practical scenarios where IVIG therapy is indicated and potential pitfalls commonly encountered with IVIG therapy, to aid clinicians in optimizing treatment of patients • Explain critical pathways in the pathogenesis of dermatomyositis, with an emphasis on insights derived from targeted inhibition of interferon-beta and type I interferon more broadly, as well as signaling through TYK2/JAK1 • Critically assess potential future approaches targeting autoantibodies, specifically reviewing clinical trials involving FcRn inhibitors for myositis as well as other immune-mediated diseases Idiopathic inflammatory myopathies (IIM) are a group of complex and heterogeneous disease entities, and clinicians face significant challenges in managing these..."

Dermatomyositis • Immunology • Myositis • TYK2

VALOR: A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis (clinicaltrials.gov) - P3 | N=241 | Completed | Sponsor: Priovant Therapeutics, Inc. | Active, not recruiting ➔ Completed

Trial completion • Dermatomyositis • Immunology • Myositis

Brepocitinib in Dermatomyositis Delivers Significant Clinical Results (EMJ Reviews) - "Cutaneous dermatomyositis manifestations improved rapidly, with statistically significant reductions in skin disease activity observed by week 4. By week 52, 44 percent of patients with moderate-to-severe baseline skin disease achieved complete clinical remission on the Cutaneous Dermatomyositis Disease Area and Severity Index. Treated individuals also recorded substantial improvements in physical functioning and disability index scores. Overall adverse event incidence remained comparable across study arms, though serious infections occurred more frequently with the 30 mg dose than with placebo. These infectious events resolved with standard medical care, and no study-related deaths occurred, establishing a favorable benefit-risk profile for this targeted oral intervention."

P3 data • Dermatomyositis • Immunology

Priovant Therapeutics…announced that the U.S. Food and Drug Administration (FDA) has approved LISRAYA (brepocitinib) 30 mg for the treatment of adults with dermatomyositis (DM) (GlobeNewswire) - "LISRAYA is a pill taken once daily....LISRAYA’s approval follows the landmark Phase 3 VALOR trial, the largest DM trial ever conducted....Priovant is committed to helping patients access LISRAYA as quickly as possible. LISRAYA is available through a limited distribution network of specialty pharmacies."

FDA approval • Launch US • Dermatomyositis

Transforming the treatment of autoimmune skin diseases: a journey through biologic therapies. (PubMed, Expert Opin Biol Ther) - "In dermatomyositis, CDASI-based evidence is strongest for IVIg, with anti-IFNβ therapy and the TYK2/JAK1 inhibitor brepocitinib (positive in a phase 3 trial) showing cutaneous benefit; other biologics show limited trial signals. Biologic/targeted therapies should be positioned by disease phenotype and evidence strength, prioritizing steroid-sparing strategies in pemphigus and BP and using CLASI/CDASI-anchored outcomes to interpret lupus and dermatomyositis data. Evidence for rare AIBDs remains mostly case-level and should be framed accordingly."

Journal • Review • Bullous Pemphigoid • Cutaneous Lupus Erythematosus • Dermatology • Dermatomyositis • Dermatopathology • Immunology • Inflammatory Arthritis • Lupus • Myositis • Rheumatology • Systemic Lupus Erythematosus • IFNB1 • IL13 • IL4 • TYK2

BEACON: A Phase 2/3 Study of Brepocitinib in Adults With Cutaneous Sarcoidosis (clinicaltrials.gov) - P2/3 | N=168 | Recruiting | Sponsor: Priovant Therapeutics, Inc. | Phase classification: P2 ➔ P2/3 | N=28 ➔ 168 | Trial completion date: Dec 2026 ➔ Dec 2029 | Trial primary completion date: Dec 2026 ➔ Dec 2028

Enrollment change • Phase classification • Trial completion date • Trial primary completion date • Immunology • Sarcoidosis

Safety and Efficacy of Brepocitinib, a TYK2/JAK1 Inhibitor, in Active Noninfectious Uveitis: A 52-Week Phase 2 Study (NEPTUNE) (AAO 2024) - "Adverse event rate was similar in both arms. Conclusion Brepocitinib demonstrated dose-dependent, clinically meaningful efficacy and was well tolerated, with a safety profile consistent with prior brepocitinib studies and pharmacologic class."

Clinical • P2 data • Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis • TYK2

Skin-Specific Outcomes of Brepocitinib in Patients With Dermatomyositis: Secondary Analysis of a Phase 3 Randomized Clinical Trial. (PubMed, JAMA Dermatol) - P3 | "In this secondary analysis of a randomized clinical trial in dermatomyositis, once-daily brepocitinib, 30 mg, resulted in rapid, durable, and remission-level control of skin disease with an acceptable safety profile. ClinicalTrials.gov Identifier: NCT05437263."

Clinical • Journal • P3 data • Dermatology • Dermatomyositis • Immunology • Myositis • Pruritus • TYK2

Orsini to Serve as Specialty Pharmacy Partner for Priovant's LISRAYA (brepocitinib) (PRNewswire)

Commercial • Dermatomyositis • Immunology

JAMA Dermatology Publishes Skin-Specific Outcomes from Phase 3 VALOR Trial Of Brepocitinib in Dermatomyositis (GlobeNewswire) - "In patients with at least moderate itch at baseline, clinically meaningful improvements were observed as early as Week 4 in 54% of brepocitinib 30 mg patients versus 10% with placebo, increasing to 74% versus 33%, respectively, by Week 52...Improvements in skin disease occurred alongside reductions in oral corticosteroid (OCS) use. Among patients receiving OCS at baseline, 61.7% of patients treated with brepocitinib 30 mg tapered to 2.5 mg/day (prednisone-equivalent) or less by Week 52 compared to 34.4% receiving placebo, while 41.7% discontinued OCS altogether compared with 23.4% receiving placebo."

P3 data • Dermatomyositis • Immunology

In non-infectious uveitis (NIU), the Phase 3 CLARITY trial is anticipated to read out later this year. (Yahoo Finance)

P3 data • Immunology • Uveitis

In dermatomyositis (DM), brepocitinib’s NDA is currently under Priority Review with FDA with a PDUFA date later this quarter, following the positive Phase 3 VALOR readout. (Yahoo Finance) - "...product launch in DM expected by the end of September 2026."

FDA approval • Launch US • Dermatomyositis • Immunology

Priovant Announces First Patients Enrolled in Phase 3 Study (BEACON+) of Brepocitinib in Cutaneous Sarcoidosis (CS) (Yahoo Finance) - "The Phase 3 study (BEACON+) will be conducted as a Part B to the positive Phase 2 BEACON trial. BEACON+ will enroll approximately 140 patients with cutaneous sarcoidosis across approximately 70 sites globally. Patients will be randomized 3:2 between brepocitinib 45mg once daily and placebo...Topline data from the BEACON+ study is expected in calendar year 2028."

Enrollment open • P3 data: top line • Immunology • Sarcoidosis

Emerging synthetic drugs for the management of Hidradenitis Suppurativa: a comprehensive update. (PubMed, Expert Opin Pharmacother) - "Currently, only three biologic agents - adalimumab, secukinumab, and bimekizumab - hold regulatory approval for moderate-to-severe HS...Mechanistic classes discussed include Janus kinase (JAK) inhibitors (povorcitinib, upadacitinib, ruxolitinib), TYK2 inhibitors (brepocitinib, ropsacitinib, deucravacitinib), PDE-4 inhibitors (apremilast, orismilast, roflumilast), BTK/SYK inhibitors (remibrutinib, fostamatinib), IRAK-4 inhibitors (zimlovisertib), and HSP-90 inhibitors (RGRN-305)...The emergence of topical JAK inhibitors (ruxolitinib cream) for milder HS and the progression of BTK inhibitors (remibrutinib) to Phase 3 trials signal a broadening treatment landscape. Personalized selection of synthetic drugs versus biologics - informed by patient comorbidities, disease phenotype, and biomarkers - will be involved in next-generation HS management."

Journal • Review • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • IRAK4 • JAK1 • SYK • TYK2

Efficacy and Safety of Brepocitinib in Patients with Cutaneous Sarcoidosis: Results from a Randomized, Double-Blind, Multicenter, Placebo-Controlled, Phase II (BEACON) Trial (WASOG 2026) - No abstract available

Clinical • P2 data • Immunology • Sarcoidosis

Comparative efficacy of Janus kinase inhibitors in severe alopecia areata: a network meta-analysis based on randomized controlled trials. (PubMed, Postgrad Med J) - "The efficacy of JAK inhibitors in the treatment of severe AA is definitive, and all possess a dose-dependent effect. This study provides valuable insights for clinicians in selecting appropriate pharmacological interventions for severe AA. Key messages What is already known on this topic: Alopecia areata is an autoimmune disorder characterized by patchy hair loss on the scalp. Previous studies have demonstrated that JAK inhibitors can effectively treat alopecia areata, but research comparing the efficacy of different JAK inhibitors is lacking. What this study adds: This study established a ranking of efficacy for different JAK inhibitors in treating severe alopecia areata, providing a reference for selecting clinical treatment regimens. How this study might affect research, practice, or policy: Future studies are needed to directly compare the efficacy of different JAK inhibitors in treating alopecia areata. This will provide more reliable evidence for formulating..."

Journal • Retrospective data • Alopecia • Immunology

Large-scale meta-analysis of infection risk with JAK-STAT inhibitors in 29,000 patients. (PubMed, J Eur Acad Dermatol Venereol) - "This meta-analysis provides a comprehensive assessment of the risk of infection associated with JAK-STAT inhibitors in IMIDs of the skin. Although overall safety is acceptable, clinicians should be aware of the higher infection risk of influenza and herpes zoster and should consider vaccination and preventive strategies for high-risk patients with atopic dermatitis. The main limitation is that the included studies involved highly selected populations with few comorbidities and short follow-up."

Journal • Retrospective data • Review • Alopecia • Atopic Dermatitis • Dermatitis • Dermatology • Herpes Zoster • Immunology • Infectious Disease • Inflammation • Influenza • Pulmonary Disease • Respiratory Diseases • Varicella Zoster • Vitiligo

Brepocitinib Demonstrates Consistent Benefit on Combined Measures of Clinical Response and Sustained Corticosteroid Tapering in Dermatomyositis Patients at One Year (EULAR 2026) - "For participants receiving OCS at baseline, tapering to 5 mg/day of prednisone-equivalent dosing was required unless clinical worsening occurred; tapering below 5 mg/day was encouraged at investigator discretion. These results highlight the potential for brepocitinib to deliver clinically meaningful efficacy while simultaneously reducing corticosteroid dependence. Taken together, this combined benefit supports brepocitinib as a steroid-sparing, potential therapy for patients with DM."

Clinical • Dermatomyositis • Immunology • Myositis • JAK1 • TYK2

Rapid, Clinically Meaningful Improvement in Skin Disease with Brepocitinib in Dermatomyositis: Results from the Phase 3 VALOR Trial (EULAR 2026) - P2, P3 | "In both trials, clinically meaningful efficacy was observed by Week 4 and increasing benefit was observed through Week 12. Together, these results demonstrate rapid, meaningful benefits of brepocitinib 30 mg on skin disease activity and support brepocitinib as a targeted, potential therapy for patients with DM."

Clinical • P3 data • Dermatology • Dermatomyositis • Immunology • Myositis • JAK1 • TYK2