American College of Gastroenterology | Annual Scientific Meeting | 2026

AbbVie Reports New Skyrizi Intestinal Healing Results From Phase 3 AFFIRM Trial

AbbVie has announced additional Phase 3 AFFIRM findings showing higher rates of intestinal healing with subcutaneous Skyrizi (risankizumab) than with placebo in adults with moderately to severely active Crohn’s disease.

Higher Healing Rates at Weeks 12 and 24

The latest analysis assessed endoscopic remission and ulcer-free endoscopy. Endoscopic remission measures intestinal inflammation according to the study’s criteria, while ulcer-free endoscopy evaluates the absence of ulcers.

	Skyrizi	Placebo
Week 12 endoscopic remission	27.7%	10.2%
Week 12 ulcer-free endoscopy	26.2%	10.2%
Week 24 endoscopic remission	35.8%	9.1%
Week 24 ulcer-free endoscopy	36.6%	9.1%

In the overall study population, both outcomes occurred more frequently with Skyrizi than with placebo, with higher Skyrizi response rates at week 24 than at week 12.

Outcomes Varied by Previous Treatment

Patients who had not previously received advanced therapy recorded the highest response rates among the reported subgroups. At week 24, 45.1% achieved endoscopic remission and 49.0% achieved ulcer-free endoscopy with Skyrizi. Placebo rates were 6.7% for both measures.

Among patients with an inadequate response to previous advanced therapy, week-24 endoscopic remission reached 30.1% with Skyrizi versus 10.3% with placebo. Ulcer-free endoscopy occurred in 28.9% and 10.3%, respectively.

Tremfya Shows Fistula Remission Across Crohn’s Disease Subgroups in Phase 3 Study

Johnson & Johnson has reported new Phase 3 subgroup findings showing higher rates of combined fistula remission with Tremfya (guselkumab) than with placebo in adults with Crohn’s disease and perianal fistulas.

Week-24 Remission Results

In the overall population, combined fistula remission at week 24 was achieved by 28% of patients receiving Tremfya 100 mg every eight weeks and 27% receiving 200 mg every four weeks, compared with 10% receiving placebo.

	Tremfya 100 mg every 8 weeks	Tremfya 200 mg every 4 weeks	Placebo
Higher baseline intestinal disease activity, CDAI ≥220	30%	21%	0%
Previous biologic exposure	21%	29%	5%
Proctitis at baseline	26%	27%	12%
No proctitis at baseline	29%	27%	10%

Findings in Previously Treated Patients

Among patients previously exposed to biologic therapies, remission rates were 21% with the 100 mg schedule and 29% with the 200 mg schedule, versus 5% with placebo.

Higher rates were also observed with Tremfya regardless of whether patients had proctitis at baseline. These results broaden the overall findings to patients with differing treatment histories and disease characteristics.