Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- 2 days ago
- 3 min read
Updated: 2 days ago
02/03/2026
Lynk Pharmaceuticals announced positive Phase 3 data for zemprocitinib in moderate-to-severe atopic dermatitis (Ref)
Lynk Pharmaceuticals announced positive topline results from its Phase 3 trial that evaluated zemprocitinib (a JAK1 inhibitor) in patients with moderate-to-severe atopic dermatitis (AD)
The study met all co-primary and key secondary endpoints, with both dose groups demonstrating highly and statistically significant improvements Vs placebo (p < 0.0001)
EASI-75 differences were 38.1% (12 mg) and 46.4% (24 mg) (p < 0.0001) Vs placebo
vIGA-AD 0/1 improvement were 30.3% (12 mg) and 31.0% (24 mg) (p < 0.0001) over placebo
WI-NRS4 response rates were 31.3% (12 mg) and 31.0% (24 mg) higher than placebo at Week 16 (p < 0.0001)
Zemprocitinib demonstrated a favorable overall safety and tolerability profile
Abbive announced topline results form a Phase 3 study that evaluated resankizumab subcutaneous induction in patients with CD (Ref)
Abbive announced positive topline results from its Phase 3, AFFIRM/ NCT06063967 study which evaluated Skyrizi (risankizumab; IL-23 inhibitor) subcutaneous induction treatment in patients with moderately to severely active Crohn's disease (CD)
The AFFIRM study results demonstrated significantly greater proportion of patients treated with risankizumab SC induction achieved the co-primary endpoints at week 12 compared to placebo:
CDAI clinical remission: 55% vs 30%; p<0.0001
Endoscopic response: 44% vs 14%; p<0.0001
Among patients with clinical response after 12 weeks of risankizumab SC induction treatment followed by 12 weeks of maintenance:
CDAI clinical remission: 67% at week 24
Endoscopic response: 57% at week 24
During the 12 week study, the safety profile of risankizumab SC was consistent with the safety profile observed in CD with no new safety risks observed
Full results of the study were to be published in an upcoming medical journal and shared at future medical congresses
Roche announced positive results from a Phase 3 study that evaluated fenebrutinib in patients with RMS (Ref)
Roche announced findings from its pivotal phase 3, FENhance 1/ NCT04586010 study of fenebrutinib (BTK inhibitor) in patients with relapsing multiple sclerosis (RMS)
The study met its primary endpoint showing a significantly reduced relapses by 51% compared to teriflunomide in RMS, consistent with FENhance 2/ NCT04586023 results which had shown a 59% reduction
Secondary endpoints in both RMS studies showed statistically significant and clinically meaningful reductions in brain lesions
FENhance 1 was the final study readout of the fenebrutinib pivotal clinical development programme in MS following positive results for FENhance 2 in RMS and for FENtrepid/ NCT04544449 in primary progressive multiple sclerosis (PPMS)
Full data from the FENhance 1 and 2 studies were to be shared at the American Academy of Neurology (AAN) Annual Meeting 2026
Totality of data from all three Phase 3 fenebrutinib studies were to be submitted to regulatory authorities
Sanofi's rilzabrutinib earned orphan drug designation in Japan for IgG4-related disease (Ref)
The Ministry of Health Labour and Welfare (MHLW) in Japan granted orphan drug designation to rilzabrutinib (BTK inhibitor) for patients with IgG4-related disease (IgG4-RD)
The designation was based on positive data from the Phase 2/ NCT04520451 study of rilzabrutinib in IgG4-RD
The phase 2 study evaluated rilzabrutinib in patients with IgG4-RD, in this study rilzabrutinib was administered for 52 weeks and led to a reduction in disease flares and other disease markers and minimized the need for treatment with glucocorticoids
The safety profile of rilzabrutinib in the study was consistent with previous studies in other indications, with no new safety signals observed
