title: Efalizumab, a human monoclonal anti-CD11a antibody, in the treatment of moderate to severe Crohn's Disease: an open-label pilot study.
abstract: OBJECTIVE
  Efalizumab is a monoclonal antibody targeting CD11a, an adhesion molecule involved in the activation and trafficking of T-lymphocytes. This agent has proven efficacy in the treatment of psoriasis. We performed an open-label study to evaluate the efficacy and safety of efalizumab in Crohn's disease (CD).
  
  
  METHODS
  Fifteen subjects with moderate to severe CD (Crohn's Disease Activity Index [CDAI] score 220-450) and who were refractory or intolerant to standard therapy, received a weekly 1 mg/kg subcutaneous injection of efalizumab for 8 weeks. The primary endpoint was clinical response (decrease in the CDAI score of at least 70 points) at week 8. Secondary endpoints included change in mean CDAI scores, the proportion of subjects who achieved clinical remission (CDAI score ≤ 150), change in the Inflammatory Bowel Disease Questionnaire (IBDQ) scores, and report of adverse events.
  
  
  RESULTS
  At 8 weeks, ten (67%) subjects had clinical response and six (40%) were in remission. The mean baseline and week 8 CDAI scores were 300 and 167 respectively (P < 0.001). Mean IBDQ scores at baseline and week 8 were 124 and 168 respectively (P < 0.001). One subject with Crohn's colitis had pre- and post-treatment colonoscopy that demonstrated mucosal healing. No serious adverse events occurred.
  
  
  CONCLUSIONS
  Efalizumab induced a clinical response in the majority of subjects with moderate to severe CD in this small, open-label pilot study. There were no serious adverse events reported during this short-term trial.
authors.affiliation: Division of Gastroenterology, Washington University School of Medicine, Saint Louis, MO, USA.
authors.forename: Dustin G
authors.initials: DG
authors.lastname: James
authors.forename: Da Hea
authors.initials: DH
authors.lastname: Seo
authors.forename: Jiajing
authors.initials: J
authors.lastname: Chen
authors.forename: Caroline
authors.initials: C
authors.lastname: Vemulapalli
authors.forename: Christian D
authors.initials: CD
authors.lastname: Stone
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D003424:Crohn Disease / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; C472181:efalizumab