Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- 6 days ago
- 3 min read
28/03/2026
Biogen announced Phase 2 results for litifilimab for CLE (Ref)
Biogen announced positive results from part A of its Phase2/3 AMETHYST/ NCT05531565 study, which evaluated litifilimab (BDCA2) for the treatment of patients with cutaneous lupus erythematosus (CLE)
Part A of AMETHYST evaluated the efficacy and safety of litifilimab through week 24, with reductions in skin disease activity reported across several measures
AMETHYST Part A met its primary endpoint with litifilimab demonstrating a statistically significant 11.8% higher reduction in disease activity in people living with CLE (p < 0.05) as measured by CLA-IGA-R erythema score of 0-1 at Week 16, compared to placebo (14.7% vs. 2.9%)
Secondary endpoints were not adjusted for multiplicity in Part A and therefore statistical significance could not be demonstrated
Litifilimab was generally well tolerated in Part A of the AMETHYST study
Results from Sanofi’s Phase 3 studies in AD were presented AAD (Ref)
Sanofi presented positive results from its three Phase 3 studies COAST 1/ NCT06130566, COAST 2/ NCT06181435, SHORE/ NCT06224348, which evaluated amlitelimab (OX40L) in moderate-to-severe atopic dermatitis (AD) as a monotherapy and in combination with topical therapies at the 2026 AAD Annual meeting
In the COAST 1 and COAST 2 studies, amlitelimab met the primary endpoint
Key secondary endpoints:
In COAST 1, the proportion of patients achieving vIGA-AD 0/1 with BPE, EASI-75 and PP-NRS ≥4 PP-NRS were statistically significant
In COAST 2, EASI-75 and PP-NRS≥4 reached nominal significance; vIGA-AD 0/1 with BPE did not reach statistical significance
In the SHORE study, amlitelimab in combination with topical therapies with or without topical calcineurin inhibitors dosed at both Q4W and Q12W demonstrated significant improvements in AD clinical signs and symptoms versus placebo as measured across primary and key secondary endpoints at Week 24
Across the three trials the safety profile of amlitelimab was consistent with previously reported data
Alumis announced Phase 3 data for envudeucitinib for plaque psoriasis (Ref)
Alumis announced new data from its Phase 3 ONWARD1/ NCT06586112 and ONWARD2/ NCT06588738 studies which evaluated envudeucitinib (a TYK2 inhibitor) for the treatment of patients with moderate-to-severe plaque psoriasis, the data were presented in a late-breaking oral session at the 2026 AAD Annual Meeting
Envudeucitinib achieved robust PASI responses by Week 16 with significant continued improvements by Week 24 in PASI 90 (68.0%, 62.1%) and PASI 100 (41.0%, 39.5%)
Envudeucitinib demonstrated a favorable safety and tolerability profile consistent with the Phase 2 program
The company planned to submit a New Drug Application to the US FDA in H2 2026
Incyte announced Phase 3 data for povorcitinib for HS (Ref)
Incyte announced data from its Phase 3 STOP-HS/ NCT06212999 trial which evaluated the safety and efficacy of povorcitinib (INCB54707; JAK1 inhibitor) for the treatment of adult patients with moderate-to-severe hidradenitis suppurativa (HS)
The STOP-HS data demonstrated substantial and durable clinical efficacy through Week 54 in patients with moderate to severe HS
Through Week 54 clinically meaningful and durable responses were observed across all groups in both STOP-HS1/ NCT05620823 and STOP-HS2/ NCT05620836
71.4% of patients achieved HiSCR50
57% of participants achieved HiSCR75
29% of participants achieved HiSCR100
The overall safety profile of povorcitinib through 54 weeks was consistent with previously reported data, and both doses were well tolerated
