Journal
JOURNAL OF CROHNS & COLITIS
Volume 15, Issue 11, Pages 1920-1930Publisher
OXFORD UNIV PRESS
DOI: 10.1093/ecco-jcc/jjab081
Keywords
Ustekinumab; Crohn's disease; real-world; ICC Registry
Categories
Funding
- AbbVie
- Pfizer
- Takeda
- Celgene
- Janssen Pharmaceutica
- Teva Pharmaceutical Industries
- Cablon Medical
- Ferring pharmaceuticals
- Mundipharma
- Sandoz
- Tramedico
- Dr. Falk Pharma
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In Crohn's disease patients treated with ustekinumab, one-third achieved corticosteroid-free clinical remission after 104 weeks, with 64.3% and 54.8% remaining on treatment at 52 and 104 weeks, respectively.
Aims: Ustekinumab is a monoclonal antibody that selectively targets p40, a shared subunit of the cytokines interleukin [IL]-12 and IL-23. It is registered for the treatment of inflammatory bowel diseases. We assessed the 2-year effectiveness and safety of ustekinumab in a real world, prospective cohort of patients with Crohn's disease [CD]. Methods: Patients who started ustekinumab were prospectively enrolled in the nationwide Initiative on Crohn and Colitis [ICC] Registry. At weeks 0, 12, 24, 52 and 104, clinical remission Harvey Bradshaw Index <= 4 points], biochemical remission (faecal calprotectin <= 200 mu g/g and/or C-reactive protein <= 5 mg/L], perianal fistula remission, extra-intestinal manifestations, ustekinumab dosage and safety outcomes were determined. The primary outcome was corticosteroid-free clinical remission at week 104. Results; In total, 252 CD patients with at least 2 years of follow-up were included. Of all included patients, the proportion of patients in corticosteroid-free clinical remission was 32.3% [81/251], 41.4% [104/251], 39% [97/249] and 34.0% [84/247] at weeks 12, 24, 52 and 104, respectively. In patients with combined clinical and biochemical disease activity at baseline [n = 122], the corticosteroid-free clinical remission rates were 23.8% [29/122], 35.2% [43/122], 40.0% [48/120] and 32.8% [39/119] at weeks 12, 24, 52 and 104, respectively. The probability of remaining on ustekinumab treatment after 52 and 104 weeks in all patients was 64.3% and 54.8%, respectively. The main reason for discontinuing treatment after 52 weeks was loss of response [66.7%]. No new safety issues were observed. Conclusion: After 104 weeks of ustekinumab treatment, one-third of CD patients were in corticosteroid-free clinical remission.
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