Adalimumab Induces and Maintains Mucosal Healing in Patients With Crohns Disease: Data From the EXTEND Trial
Gastroenterology,  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.

Results
  • 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).

Please login or register to follow this author.
► Click here to access PubMed, Publisher and related articles...
<< Previous Article | Next Article >>

    Currently, there are no available articles.

Your Unread Messages in Family Medicine

See All >> Messages include industry-sponsored communications and special communications from MDLinx

Most Popular Family Medicine Articles

Indexed Journals in Family Medicine: American Family Physician, Archives of Family Med, Annals of Family Medmore

Looking for a physician job? Let us help!

Register now for our free job placement service.
A career consultant will contact you soon.
Click Here for more information.

Get Started Now!

Free-of-charge, no obligation.

Terms and Conditions For M3 Career Consult

By registering with the M3 Career Consult service you authorize M3 USA Corporation to represent you in your job search. The following is a summary of the terms of our service and our mutual obligations to help you find a job:

  • You designate M3 to act as your agent and represent you in your job search;
  • You will not pay us for this service
  • You will advise us of any companies or positions to which you apply or have applied;
  • You will advise us if you believe you are not capable of performing a position for which we submit you, or for which you interview;
  • You will keep all information we provide you about companies or positions strictly confidential;
  • You will promptly provide us with information we request of you;
  • You will make yourself reasonably available for phone, video and in-person conversations and interviews;
  • You will be truthful in all of your communications with us; and
  • You will advise us if anything above changes.
 

The Top Read Articles of 2014 are Now Available

Scouring thousands of peer-reviewed journals and popular press, Our Editors just released the Top Read Articles of the Year. See the Top Read List