Efficacy and safety of natalizumab in Crohn's disease patients treated at 6 Boston academic hospitals
Department of Medicine, Division of Gastroenterology
Medical Subject Headings
Adult; Antibodies, Monoclonal, Humanized; Boston; Crohn Disease; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Integrin alpha4; Male; Prognosis; Remission Induction; Retrospective Studies; Safety
Digestive System Diseases | Gastroenterology
BACKGROUND: Despite trials demonstrating its efficacy, many physicians harbor concerns regarding the use of natalizumab in the treatment of patients with refractory Crohn's disease (CD). The purpose of this study was to perform a descriptive analysis of a series of CD patients not currently enrolled in a clinical trial.
METHODS: A retrospective case review of patients treated with natalizumab at 6 sites in Massachusetts: Boston Medical Center, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Lahey Clinic, Massachusetts General Hospital, and UMass Medical Center.
RESULTS: Data on 69 CD patients on natalizumab were collected. At the start of treatment, patients' disease duration was 12 years. A high proportion of patients were women (68%), presented with perianal disease (65%) and upper gastrointestinal tract involvement (14%). Prior nonbiologic therapies were steroids (96%), thiopurines (94%), antibiotics (74%), methotrexate (58%), and at least two anti-tumor necrosis factor agent failures (81%). Sixty-nine percent (44 of 64 patients) with available medical evaluation had a partial or complete clinical response. Loss of response was 13% after an average of 1 year of treatment. Adverse events were infusion reactions, headaches, fever, and infections. No case of progressive multifocal leukoencephalopathy was observed.
CONCLUSIONS: In our clinical experience outside the context of a clinical trial, natalizumab is largely reserved for CD patients with extensive ileocolonic disease who have failed conventional immunosuppressants and of at least 2 anti-tumor necrosis factor agents. This drug is, however, well tolerated and offers significant clinical improvement for more than a year in one-third of these difficult-to-treat CD patients.
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Citation: Inflamm Bowel Dis. 2013 Oct;19(11):2457-63. doi: 10.1097/MIB.0b013e3182a32a0d. Link to article on publisher's site
Juillerat, Pascal; Wasan, Sharmeel K.; Fowler, Sharyle A.; Friedman, Sonia; Pabby, Vikas K.; Coukas, Jennifer A.; Barto, Amy E.; Pellish, Randall; Germansky, Katharine A.; Cheifetz, Adam S.; Korzenik, Joshua R.; Farraye, Francis A.; and Yajnik, Vijay, "Efficacy and safety of natalizumab in Crohn's disease patients treated at 6 Boston academic hospitals" (2013). University of Massachusetts Medical School Faculty Publications. 765.