Brepocitinib Improves Cutaneous Sarcoidosis by Week 4: Aaron Mangold, MD

Brepocitinib (Lisraya), an oral selective tyrosine kinase 2 (TYK2)/Janus kinase 1 (JAK1) inhibitor, produced rapid, dose-dependent reductions in cutaneous sarcoidosis disease activity versus placebo in the phase 2 portion of the BEACON trial.1 Aaron R. Mangold, MD, professor of dermatology and medical director of the Office of Clinical Trials at Mayo Clinic in Arizona, discussed the findings with HCPLive.

Mangold presented the prespecified interim analysis at the European Academy of Dermatology and Venereology (EADV) Congress 2026 in Vienna, Austria. BEACON (NCT06978725) is an ongoing phase 2/3 trial randomizing adults with biopsy-proven active disease and a Cutaneous Sarcoidosis Activity and Morphology Instrument-Activity (CSAMI-A) score of 10 or greater to once-daily brepocitinib 45 mg (n = 13), brepocitinib 15 mg (n = 11), or placebo (n = 7), with any oral corticosteroids tapered off by week 8.1,2 The agent, already approved for adults with dermatomyositis, is the first targeted therapy with randomized, placebo-controlled efficacy data in the disease.1

"What you see specifically in the highest dose of brepocitinib is essentially all patients, 100% of them, say, 'I'm better on therapy,' which I think really, number one, aligns with the clinical assessments showing really dramatic improvement. But number two gets really critically as to why do we treat people, and it is to make them feel better," Mangold said.

At week 16, mean CSAMI-A reduction was 22.3 points with brepocitinib 45 mg versus 0.7 points with placebo (P < .0001), with separation from placebo evident by week 4.1 The 45 mg dose also yielded higher rates of Cutaneous Sarcoidosis Activity–Investigator Global Assessment clear or almost clear (9/13 [69%] vs 0/7 [0%]; P = .0047), 50% or greater CSAMI-A improvement (10/13 [77%] vs 0/7 [0%]; P = .0031), and CSAMI-A below 5 (8/13 [62%] vs 0/7 [0%]; P = .0147).

Mean Skindex-16 scores improved by 24 points in the 45 mg arm versus a 9-point worsening with placebo (P = .0027).1 All 13 patients receiving 45 mg reported improvement on the Patient Global Impression of Change, compared with 2/7 (29%) placebo recipients (P = .0014).

No deaths, serious adverse events, malignancies, major adverse cardiovascular events, venous thromboembolic events, or viral reactivations occurred.¹ Mangold noted the 31-patient study was not designed to characterize overall safety, pointing instead to the larger brepocitinib exposure across other indications, including dermatomyositis. The 45 mg dose is advancing into the phase 3 portion of BEACON; these data come from a congress abstract and have not been peer reviewed.

Relevant disclosures for Mangold include arGEN-X, Bristol Myers Squibb, Boehringer Ingelheim, Clarivate, Incyte, Priovant, and Sun Pharma.

References

1. Rosenbach M, Shields B, Coates M, et al. Efficacy and safety of brepocitinib in cutaneous sarcoidosis: results from the phase II portion of the randomized, double-blind, placebo-controlled BEACON trial. Abstract 145. Presented at: EADV Congress 2026; September 30–October 3, 2026; Vienna, Austria.

2. A study of brepocitinib in adults with cutaneous sarcoidosis (BEACON). ClinicalTrials.gov identifier: NCT06978725. Updated August 25, 2026. Accessed October 9, 2026. https://clinicaltrials.gov/study/NCT06978725