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Randomized Controlled Trial
. 2025 Jan 17;74(2):197-205.
doi: 10.1136/gutjnl-2024-333281.

Top-down infliximab plus azathioprine versus azathioprine alone in patients with acute severe ulcerative colitis responsive to intravenous steroids: a parallel, open-label randomised controlled trial, the ACTIVE trial

Aurelien Amiot  1 , Philippe Seksik  2 , Antoine Meyer  3 , Carmen Stefanescu  4 , Pauline Wils  5 , Romain Altwegg  6 , Lucine Vuitton  7 , Laurianne Plastaras  8 , Adrien Nicolau  9 , Bruno Pereira  10 , Nicoals Duveau  11 , David Laharie  12 , Bassirou Mboup  13 , Medina Boualit  14 , Matthieu Allez  15 , Sylvie Rajca  16 , Elise Chanteloup  17 , Guillaume Bouguen  18   19 , Thomas Bazin  20 , Felix Goutorbe  21 , Nicolas Richard  22 , Driffa Moussata  23 , Eric Vicaut  24 , Laurent Peyrin-Biroulet  25   26
Affiliations
Randomized Controlled Trial

Top-down infliximab plus azathioprine versus azathioprine alone in patients with acute severe ulcerative colitis responsive to intravenous steroids: a parallel, open-label randomised controlled trial, the ACTIVE trial

Aurelien Amiot et al. Gut. .

Abstract

Background: It is unknown which maintenance therapy is the most effective option for patients admitted for an acute severe ulcerative colitis (ASUC) episode responding to intravenous steroids.

Methods: We conducted a multicentre, parallel-group, open-label randomised controlled trial among 23 French centres in thiopurine and biologics-naïve adults admitted for ASUC responding to intravenous steroids. Eligible patients were randomly assigned to receive infliximab (IFX) and azathioprine (AZA) with a 7-day steroid tapering scheme (IFX+AZA arm) or AZA and conventional standardised steroid tapering regimen (AZA arm). The primary composite endpoint was treatment failure at week 52, defined as the absence of steroid-free clinical remission, the absence of endoscopic response, the use of a prohibited treatment for relapse, severe adverse event leading to treatment interruption, colectomy or death. Multiple imputation for missing data was performed.

Findings: Among the 64 patients randomised (Lichtiger score 13.5±2.0; median age of 34.5 (P25-P75 26.3-50.3) years, median C reactive protein of 29.0 (12.8-96.8) mg/L at baseline): 32 were assigned to the IFX+AZA arm and 32 to the AZA arm. In the ITT population, treatment failure at week 52 was observed in 22/27 (81.5%) in the AZA arm and 16/30 (53.3%) in the IFX+AZA arm (risk ratio 3.85, 95% CI (1.15 to 12.88), p=0.03). 29 adverse events were severe, including 13 disease exacerbations, 6 severe infections without any difference between both arms.

Interpretation: Combination therapy with IFX+AZA was more effective at 1 year than AZA alone to avoid treatment failure in patients with ASUC responding to intravenous steroids.

Trial registration number: NCT02425852.

Keywords: AZATHIOPRINE; INFLIXIMAB; ULCERATIVE COLITIS.

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Conflict of interest statement

Competing interests: AA received consulting fees from Abbvie, Pfizer, Takeda, Tillotts Pharma, Janssen and Sandoz as well as lecture fees and travel accommodations from Abbvie, Janssen, Pfizer, Takeda, Biogen, Fresenius Kabi, Amgen and Celltrion. PS reports consulting fees from Pfizer, Astellas, Janssen, Fresenius Kabi, Takeda, Abbvie, Merck-MSD, Pilège, Lilly, Celltrion and Biocodex; and grants from Biocodex and Janssen. CS declare lecture and/or consulting fees from Abbvie, Amgen, Celltrion, Janssen, Lilly, Takeda, Tillots. PW received board membership, consultancy, or lecture fees from Abbvie, Amgen, Celltrion, Ferring, Janssen, and Takeda. LV received fees from Abbvie, Amgen, MSD, Ferring, Takeda, Pfizer, Celltrion, Janssen, Galapagos, Dr Falk. RA declares lecture fees from MSD, Abbvie, Pfizer, Takeda, and Janssen. GB received lecture fees from Abbvie, Ferring, Takeda and Pfizer and consultant fees from Takeda, Janssen, Lilly, Celltrion, Sandoz, Abbvie. MB has received lecture fees and travel accommodation from Abbvie, Fresenius Kabi, Janssen, Pfizer and Takeda. DL has received counseling, boards, transports and/or fees from Abbvie, Amgen, Biogen, Ferring, Galapagos, Janssen, Lilly, MSD, Novartis, Pfizer, Prometheus, Roche, Takeda, Tillots. MA has served as a speaker, consultant, and/or advisory board member for Abbvie, Amgen, Biogen, Boehringer-Ingelheim, Celgene, Celltrion, Ferring, Galapagos, Genentech, IQVIA, Janssen, Lilly, MSD, Pfizer, Roche, Takeda, Tillotts. FG declares counseling, boards, transports and lectures fees from Abbvie, Amgen, Biogen, Celltrion, Janssen, Lilly, MSD, Pfizer, Takeda. NR has received lecture fees from AbbVie and Takeda. LP-B received consulting fees from Merck, Abbvie, Janssen, Genentech, Ferring, Norgine, Tillots, Vifor, Shire, Therakos, Pharmacosmos, Pilège, BMS, UCB-Pharma, Hospira, Celltrion, Takeda, Biogaran, Boerhinger-Ingelheim, Lilly, Pfizer and HAC-Pharma. This author also received lecture fees from Merck, Abbvie, Takeda, Janssen Cilag, Ferring, Norgine, Tillots, Vifor, Therakos, HAC-Pharma and Mitsubishi. No conflicts of interest are claimed by the remaining authors.

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