Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- 2 days ago
- 2 min read
Updated: 1 day ago
05/05/2026
J&J announced Phase 2b data from two studies in IBD (Ref)
Johnson & Johnson announced data from two Phase 2b studies, DUET-UC/ NCT05242484 and DUET-CD/ NCT05242471, which evaluated JNJ-4804 (IL-23 and TNF-α) in patients with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD) with disease refractory to systemic therapies.
JNJ-4804 demonstrated the highest rate of clinical and endoscopic outcomes compared with golimumab and guselkumab in patients with UC or CD who had inadequate response to two or more systemic therapy.
DUET-CD study:
JNJ-4804 demonstrated higher clinical remission rates (50.8% Vs 25.4%) and endoscopic response rates (38.1% Vs 19.8%) versus golimumab at Week 48.
DUET-UC study:
JNJ-4804 demonstrated superior clinical remission rates (41.0% Vs 11.5%) compared to golimumab, at week 48.
In both studies safety findings were generally consistent with the known profiles of the component monotherapies.
J&J announced Phase 3 results for guselkumab in CD (Ref)
Johnson & Johnson announced results from the two Phase 3, FUZION CD/ NCT05347095 study, which evaluated TREMFYA® (guselkumab; IL-23) in adult patients with active perianal fistulizing Crohn’s disease (CD).
The study met its primary endpoint of combined fistula remission at Week 24, Combined fistula remission was achieved by 28.3% of patients receiving TREMFYA 100 mg Q8W and 27.0% of patients receiving TREMFYA 200 mg Q4W compared with 10.3% for placebo.
The treatment differences versus placebo were statistically significant for both the 100 mg Q8W and 200 mg Q4W dosing regimens (p=0.007 and p=0.013, respectively).
Adverse events through 24 weeks were consistent with the known safety profile of TREMFYA in CD.
Avalo Therapeutics announced positive Phase 2 results for abdakibart in HS (Ref)
Avalo Therapeutics announced positive topline results from its Phase 2, LOTUS/ NCT06603077, study which evaluated the efficacy and safety of abdakibart (IgG4) in adults with moderate to severe hidradenitis suppurativa (HS).
The LOTUS trial met its primary endpoint at both doses150 mg (p=0.018), 300mg (p=0.015) and combined (p=0.004), demonstrating a 42.2% and 42.9% absolute improvement in HiSCR75 response rates at Week 16.
Abdakibart regimens also demonstrated statistically significant benefit across the key secondary endpoints of HiSCR50 response, change in IHS4 and change in draining tunnel count.
Based on these data, the company planned to advance abdakibart into a registrational Phase 3 program.
Abdakibart was well tolerated throughout the study.
Avalo expected to present full results from the LOTUS trial at an upcoming medical congress.
