Efalizumab, a Human Monoclonal Anti-CD11a Antibody, in the Treatment of Moderate to Severe Crohn’s Disease: An Open-Label Pilot Study
- 19 December 2010
- journal article
- research article
- Published by Springer Science and Business Media LLC in Digestive Diseases and Sciences
- Vol. 56 (6), 1806-1810
- https://doi.org/10.1007/s10620-010-1525-6
Abstract
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). 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. 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. 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.Keywords
This publication has 16 references indexed in Scilit:
- The Binding Specificity and Selective Antagonism of Vedolizumab, an Anti-α4β7Integrin Therapeutic Antibody in Development for Inflammatory Bowel DiseasesThe Journal of pharmacology and experimental therapeutics, 2009
- Blockade of CD11a by Efalizumab in Psoriasis Patients Induces a Unique State of T-Cell HyporesponsivenessJournal of Investigative Dermatology, 2008
- Adalimumab for Maintenance of Clinical Response and Remission in Patients With Crohn’s Disease: The CHARM TrialGastroenterology, 2007
- Progressive Multifocal Leukoencephalopathy Complicating Treatment with Natalizumab and Interferon Beta-1a for Multiple SclerosisThe New England Journal of Medicine, 2005
- Progressive Multifocal Leukoencephalopathy after Natalizumab Therapy for Crohn's DiseaseThe New England Journal of Medicine, 2005
- Extended efalizumab therapy improves chronic plaque psoriasis: Results from a randomized phase III trialJournal of the American Academy of Dermatology, 2005
- Development and validation of a new, simplified endoscopic activity score for Crohn's disease: the SES-CDGastrointestinal Endoscopy, 2004
- Alteration in Expression of β2 Integrins on Lamina Propria Lymphocytes in Ulcerative Colitis and Crohn's DiseaseClinical Immunology, 2002
- Maintenance infliximab for Crohn's disease: the ACCENT I randomised trialThe Lancet, 2002
- Lymphocyte function-associated antigen-1 (LFA-1) interaction with intercellular adhesion molecule-1 (ICAM-1) is one of at least three mechanisms for lymphocyte adhesion to cultured endothelial cells.The Journal of cell biology, 1988