Efficacy and Safety of Natalizumab in Crohn’s Disease Patients Treated at 6 Boston Academic Hospitals

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.; Yajnik, Vijay (2013). Efficacy and Safety of Natalizumab in Crohn’s Disease Patients Treated at 6 Boston Academic Hospitals. Inflammatory bowel diseases, 19(11), pp. 2457-2463. Lippincott Williams & Wilkins 10.1097/MIB.0b013e3182a32a0d

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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 & 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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Gastro-intestinal, Liver and Lung Disorders (DMLL) > Clinic of Visceral Surgery and Medicine > Gastroenterology

UniBE Contributor:

Juillerat, Pascal

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1078-0998

Publisher:

Lippincott Williams & Wilkins

Language:

English

Submitter:

Lilian Karin Smith-Wirth

Date Deposited:

13 Jun 2014 11:30

Last Modified:

06 Nov 2015 09:57

Publisher DOI:

10.1097/MIB.0b013e3182a32a0d

Uncontrolled Keywords:

Crohn's disease, inflammatory bowel disease, natalizumab, safety, efficacy, clinical practice

BORIS DOI:

10.7892/boris.53060

URI:

https://boris.unibe.ch/id/eprint/53060

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