Premium
Systematic review: infliximab therapy in ulcerative colitis
Author(s) -
GISBERT J. P.,
GONZÁLEZLAMA Y.,
MATÉ J.
Publication year - 2007
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.2006.03131.x
Subject(s) - infliximab , medicine , ulcerative colitis , placebo , number needed to treat , adverse effect , randomized controlled trial , odds ratio , number needed to harm , gastroenterology , meta analysis , surgery , relative risk , confidence interval , tumor necrosis factor alpha , pathology , alternative medicine , disease
Summary Aim To perform a systematic review and meta‐analysis on the efficacy and tolerance of infliximab in ulcerative colitis. Methods Selection of studies : evaluating efficacy of infliximab in ulcerative colitis. For the meta‐analysis, randomized clinical trials comparing infliximab vs. placebo/steroids. Search strategy : electronic and manual. Study quality : independently assessed by two reviewers. Data synthesis : meta‐analysis combining the odds ratios (OR). Results Thirty‐four studies (896 patients) evaluated infliximab therapy in UC, with heterogeneous results. Mean short‐term (2.3 weeks) response and remission with infliximab was 68% (95% CI 65–71%) and 40% (36–44%). Mean long‐term (8.9 months) response and remission was 53% (49–56%) and 39% (35–42%). Five randomized double‐blind studies compared infliximab with placebo, the meta‐analysis showing an advantage ( P < 0.001) of infliximab in all endpoints (short‐/long‐term response/remission): ORs from 2.7 to 4.6, and number‐needed‐to‐treat (NNT) from 3 to 5. Similar infliximab response was calculated independently of the indication (steroid‐refractory/non‐steroid‐refractory) or the dose (5/10 mg/kg). Adverse effects were reported in 83% and 75% of the infliximab and placebo‐treated patients (OR = 1.52; 95% CI 1.03–2.24; number‐needed‐to‐harm (NNH) was 14). Conclusion Infliximab is more effective than placebo, with an NNT from 3 to 5, for the treatment of moderate‐to‐severe UC, achieving clinical remission in 40% of the patients at approximately 9 months of follow‐up. Further studies are necessary to confirm the long‐term efficacy of infliximab in ulcerative colitis.