Adalimumab in active ulcerative colitis: A “real-life” observational study

Abstract

a b s t r a c tBackground and aims: The effectiveness of adalimumab in the treatment of ulcerative colitis is under debate. Although controlled trials have shown that adalimumab is significantly better than placebo, the absolute clinical benefit is modest. We report data on the effectiveness of adalimumab in a cohort of ulcerative colitis patients treated in 22 Italian centres. Methods: All patients with active disease treated with adalimumab were retrospectively reviewed. Coprimary endpoints were clinical remission at weeks 4, 12, 24 and 54. Secondary endpoints were sustained clinical remission, steroid discontinuation, endoscopic remission and need for colectomy. Results: Eighty-eight patients were included. Most patients had received previous infliximab treatment. Clinical remission rates were 17%, 28.4%, 36.4% and 43.2% at 4, 12, 24 and 54 weeks respectively. Twentytwo patients required colectomy. Clinical remission and low C-reactive protein at week 12 predicted clinical remission at week 54 (OR 4.17, 95% CI 2.36-19.44; OR 2.63, 95% CI 2.32-14.94, respectively). Previous immunosuppressant use was associated with a lower probability of clinical remission at week 54 (OR 0.67, and with a higher rate of colectomy (HR 9.7, 95% CI 1.46-9.07). Conclusion: In this large "real-life" experience adalimumab appears effective in patients with otherwise medically refractory ulcerative colitis. Patients achieving early remission can expect a better long-term outcome.

Adalimumab for Ulcerative Colitis: Results of a Brazilian Multicenter Observational Study

“…At week 52, all patients (15 cases) were in remission (29) , unlike the rates described in the literature and in the present study (1,2,28) . It was expected that clinical remission rates in this study could be lower as most of the sample comprised patients with previous IFX exposure and with extensive disease (pancolitis) (29) .…”

“…The rates were 17% and 28.4% at weeks 4 and 12, respectively (2) , lower than the rates at week 8 in our study, which was 41.7%. The induction dose in the Italian group was heterogeneous, 160/80 mg of ADA in 17 patients and 80/40 mg of ADA in 11 patients.…”

“…A second Italian multicenter study with a larger sample of patients reported lower rates of clinical remission (2) . The rates were 17% and 28.4% at weeks 4 and 12, respectively (2) , lower than the rates at week 8 in our study, which was 41.7%.…”

“…As all biological agents, IFX can be immunogenic, thus infusion reactions and secondary loss of response, related to antibodies to the drug may be a relevant problem (11) . ADA is a fully human monoclonal antibody and recombinant immunoglobulin G1 (IgG1) (2) . This drug was approved by regulatory agencies after proven efficacy in ULTRA I and II trials (19,20,23,25) .…”

“…Furthermore, it is enquired what the ideal dose of ADA in the management of UC would be needed (12) , showing the need of data from real life studies to better define the drug's role in treatment algorithms. There is scarce real world data on the use of ADA in UC reported in Brazil and Latin America, which motivated the present study (1,2,9,10,18,28,29) . The primary aim of this study was to analyze clinical remission rates in ADA induction and maintenance in UC treatment.…”