What question did this study set out to answer?

Evaluate the real-world efficacy of upadacitinib in patients with perianal Crohn’s disease.

January 23, 2026

P0785One-Year Efficacy of Upadacitinib in Perianal Crohn’s Disease: A Multicenter Cohort Study.

Key Points

Evaluate the real-world efficacy of upadacitinib in patients with perianal Crohn’s disease.
Retrospective cohort study across 13 French centers
Included patients with active perianal Crohn's disease treated with upadacitinib
Assessed clinical remission, clinical response, MRI response, and treatment failure
Achieved clinical remission in approximately 26% of patients with fistulizing perianal CD at 12 months
63% showed clinical response at 3 months, decreasing to 30% at 12 months
MRI response was observed in 64% and MRI remission in 7% after 12 months
16% of patients underwent perianal drainage surgery
27% discontinued upadacitinib due to lack of efficacy

Abstract

Abstract Background Upadacitinib has demonstrated efficacy for induction and maintenance therapy in luminal Crohn’s disease (CD) (1). According to a post-hoc analysis of a phase 3 randomized controlled trial, upadacitinib also showed benefit in the treatment of fistulizing perianal CD (2). However, its real-world effectiveness in this specific phenotype has not yet been evaluated. Methods All consecutive patients with active perianal CD (primary and/or secondary lesions) treated with upadacitinib across 13 French centres between September 2022 and August 2025 were included in a retrospective cohort study. Clinical remission was defined as the absence of draining pus including with pressure and healing of anal ulcers and/or fissures, without the addition of new dedicated treatment for perianal lesions (antibiotics and/or topics). Clinical response was defined as improvement of at least 50% of fistulas and/or ulcers by physician’s assessment. MRI-based response and remission were also assessed. Treatment failure was defined as upadacitinib discontinuation, initiation of a new advanced therapy, or need for additional perianal surgery. Patients lost to follow-up were considered as treatment failures. Results Fifty-nine patients were included: 43/59 (73%) with fistulizing perianal CD and 16/59 (27%) with isolated primary anal ulcerations. Median age was 38 years (interquartile range 29–47); 29 (49%) were male and 11 (19%) were active smokers. All patients had previously been exposed to at least two biologics (median 4 3–5), and 40 (68%) had a history of perianal surgery, including 34/43 (79%) in the fistulizing subgroup. Among patients with fistulizing perianal CD, clinical remission was achieved in 5/43 (12%), 11/43 (26%), and 11/43 (26%) patients at 3, 6, and 12 months, respectively, while clinical response was observed in 27/43 (63%), 21/43 (49%), and 13/43 (30%) patients (Figure 1). At 12 months, MRI response was documented in 9/14 (64%) and MRI remission in 1/14 (7%) patients with fistulizing perianal CD. Among those with isolated anal ulcerations, complete ulcer healing was observed in 4/16 (25%) at 12 months (Figure 1). No clinical or demographic factors were associated with clinical remission at 12 months in univariate analysis. Sixteen adverse events (AEs) were reported in 14 patients (27%), including three (5%) serious AEs corresponding to CD exacerbations. At 12 months, 10 patients (17%) underwent perianal drainage surgery, and 16 (27%) discontinued upadacitinib, all due to lack of efficacy. Conclusion In this real-world multicentre cohort of patients with refractory perianal CD, treatment with upadacitinib achieved clinical remission in approximately one-quarter of patients at one year. References: (1) Loftus EV, Panés J, Lacerda AP, et al. Upadacitinib Induction and Maintenance Therapy for Crohn’s Disease. N Engl J Med. 2023;388(21):1966-1980. (2) Colombel JF, Lacerda AP, Irving PM, et al. Efficacy and Safety of Upadacitinib for Perianal Fistulizing Crohn’s Disease: A Post Hoc Analysis of 3 Phase 3 Trials. Clin Gastroenterol Hepatol. 2024;0(0). Conflict of interest: Dr. Richard, Nicolas: Lecture/consultant fees from AbbVie, Amgen, Celltrion, Ferring, Janssen, Lilly, Sandoz and Takeda. Seksik, Philippe: I received personal fees from Takeda, Janssen, Merck MSD, Biocodex, Ferring, Fresenius Kabi, Astellas, Amgen, Pfizer, Pilege and Abbvie Altwegg, Romain: Advisory boards from Abbvie, Takeda, Johnson and Johnson, Lilly, Alphasigma, Celltrion, Pfizer, Amgen, Biogen, Sandoz, Ferring Nachury, Maria: Abbvie, Alfa Sigma, Biosynex, Celltrion, Galapagos, Janssen, Lilly, MSD, Pfizer, Takeda Laharie, David: Personal Fees: Board, consulting and lecture fees from Abbvie, Alfasigma, Amgen, Biocon, Celltrion, Ferring, Fresenius-Kabi, Johnson & Johnson, Lilly, MSD, Pfizer, Sandoz and Takeda Nancey, Stéphane: board membership and lecturing fees from Abbvie, Takeda, Celltrion Healthcare, Pfizer, Galapagos, Johnson & Jonshon, Lilly, Fresenius, Amgen, Medac, MSD. Coffin, Benoît: No conflict of interest Pelletier, Anne-Laure: •ALP has received lecture/consultant fees from Janssen, Pfizer, and Novartis. Uzzan, Mathieu: Grant: ECCO-IOIBD, Fondation pour la Recherche Medicale (FRM), SNFGE Personal Fees: Abbvie, Takeda, Celltrion, Janssen, Amgen, Alfasigma, Pfizer Amiot, Aurelien: Personal Fees: Abbvie, Fresenius-Kabi, Adacyte, Tillotts pharma, Janssen, Pfizer, Biogen, AMgen, Sandoz, Takeda, Galapagos, Eli Lilly Amil, Morgane: No conflict of interest Vuitton, Lucine: •LV has received fees for lectures and/or consulting fees from Abbvie, Amgen, Johnson & Johnson, Celltrion, Takeda, Pfizer, Lilly, Ferring, MSD, Dr Falk Pharma, Nordic Pharma, Alpha sigma. Fumery, Mathurin: •M.F. has received lecture/consultant fees from AbbVie, Ferring, Tillotts, MSD, Biogen, Amgen, Fresenius, Hospira, Sandoz, Pfizer, Celgene, Gilead, Boehringer, Galapagos, Janssen, and Takeda. N.R. has received lecture/consultant fees from AbbVie, Janssen and Takeda. Bozon, Anne: No conflict of interest

Mark Helpful

Bookmark

Relay