Adalimumab Induces and Maintains Mucosal Healing in Patients With Crohns Disease: Data From the EXTEND Trial
Gastroenterology, 05/11/2012
Clinical Article
Rutgeerts P et al. – Following induction therapy with adalimumab, patients with moderately to severely active CD who continue to receive adalimumab are more likely to achieve mucosal healing than those given placebo.
Methods- A randomized, double–blind, placebo–controlled trial (extend the safety and efficacy of adalimumab through endoscopic healing [EXTEND]) evaluated adalimumab for induction and maintenance of mucosal healing in 135 adults with moderate to severe ileocolonic CD.
- The baseline degree of mucosal ulceration was documented by ileocolonoscopy.
- All patients received induction therapy (subcutaneous adalimumab 160/80 mg at weeks 0/2).
- At week 4, patients were randomly assigned to groups given 40 mg adalimumab or placebo every other week through week 52.
- Open–label adalimumab was given to patients with flares or no response, starting at week 8.
- Mucosal healing was reassessed by ileocolonoscopy at weeks 12 and 52.
- Twenty–seven percent of patients receiving adalimumab had mucosal healing at week 12 (the primary end point) versus 13% given placebo (P = .056).
- At week 52, rates of mucosal healing were 24% and 0, respectively (P < .001).
- Remission rates, based on the Crohn's Disease Endoscopic Index of Severity, were 52% for adalimumab and 28% for placebo at week 12 (P = .006) and 28% and 3%, respectively, at week 52 (P < .001).
- Rates of clinical remission based on the Crohn's Disease Activity Index were greater among patients given continuous adalimumab therapy versus placebo at weeks 12 (47% vs 28%; P = .021) and 52 (33% vs 9%; P = .001).
- Five serious (1 during induction and 4 during open–label therapy) and 3 opportunistic infections (1 in each group during double–blind therapy and 1 during open–label therapy) were reported (n = 135).
