Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- 1 day ago
- 3 min read
29/06/2026
Abbvie received positive CHMP opinion for upadacitinib for the treatment of adults and adolescents with Non-segmental Vitiligo (Ref)
AbbVie announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) had adopted a positive opinion recommending the approval of upadacitinib (RINVOQ®; JAK inhibitor) 15 mg once daily for the treatment of adult and adolescent patients with non-segmental vitiligo (NSV).
The CHMP positive opinion was supported by data from the ongoing Phase 3 Viti-Up study which evaluated the efficacy and safety of upadacitinib in adult and adolescent patients with NSV.
Upadacitinib 15 mg met both co-primary endpoints and key secondary endpoints, with significant improvements in total body and facial repigmentation.
The safety profile of upadacitinib 15 mg was consistent with that observed in approved indications, with no new safety signals.
The final European Commission decision was expected in the coming months.
Abbvie received positive CHMP opinion for upadacitinib for the treatment of adults and adolescents with severe alopecia areata (Ref)
AbbVie announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) had adopted a positive opinion recommending the approval of upadacitinib (RINVOQ®; JAK inhibitor) 15 mg and 30 mg once daily for the treatment of adult and adolescent patients with severe alopecia areata (AA).
The positive CHMP opinion was supported by data from the Phase 3 UP-AA study in which upadacitinib achieved the primary endpoint of Severity of Alopecia Tool (SALT) score ≤ 20 and key secondary endpoints, including improvements in eyebrows and eyelashes, at week 24.
The safety profile of upadacitinib 15 mg and 30 mg in period A was generally consistent with that observed in approved indications.
The final European Commission decision was expected in the coming months.
Zura Bio exceeded Phase 2 enrollment target for HS and SSc and expanded tibulizumab program (Ref)
Zura Bio announced several tibulizumab program updates.
The company completed enrollment of the Phase 2 TibuSHIELD trial of tibulizumab (Anti-IL-17 and anti-BAFF) in adults with Hidradenitis Suppurativa (HS) and exceeded the target enrollment, with 247 participants enrolled.
The company remains on track to complete enrollment of The Phase 2 TibuSURE trial of tibulizumab in adults with early diffuse cutaneous SSc exceeded its 80 participant enrollment target.
The company remained on track to completed enrollment of TibuSURE in earl July and topline data were expected in H1 2027.
Topline data from TibuSHIELD were expected in the Q4 of 2026.
Zura planned to initiate a Phase 2 study for tibulizumab in a third immune-mediated indication by year end 2026.
Dianthus Therapeutics announced the initiation of a Phase 3 trial of claseprubart in gMG (Ref)
Dianthus Therapeutics announced the initiation of the Phase 3 EMERGE/ NCT07647510 trial of claseprubart in patients with generalized Myasthenia Gravis (gMG).
EMERGE was a global, randomized, multicenter, placebo-controlled Phase 3 trial designed to evaluate claseprubart 300mg/2mL subcutaneous dosed Q2W and Q4W vs. placebo, with top-line results anticipated in 2H 2028.
Abivax announced ABETACT maintenance part 2 results for obefazimod in refractory UC (Ref)
Abivax announced positive topline results from ABTECT maintenance part 2, the supplemental portion of its Phase 3 Ulcerative Colitis maintenance program evaluating obefazimod (ABX464; an oral miR-124 enhancer) in adults with moderately to severely active Ulcerative Colitis (UC).
Part 2 evaluated a more refractory population than the registrational cohort, patients who did not achieve clinical response after induction, or who relapsed during the re-randomized maintenance Part 1.
37.2% of induction non-responders achieved clinical remission and 34.5% achieved endoscopic remission at Week 44 with continued obefazimod 50 mg.
Dose escalation to 50 mg recaptured clinical remission in 45.5% of patients who relapsed during ABTECT Maintenance Part 1, supporting dose escalation as a strategy to regain and maintain disease control.
No new safety signals emerged, and exposure-adjusted incidence rates for malignancies excluding non-melanoma skin cancer (NMSC) and for NMSC remained within expected UC
background ranges, expanding the cumulative long-term safety database ahead of filing.
Abivax said it remained on track to submit its NDA to US FDA for obefazimod in UC in the Q4 of 2026.
