Natalizumab Use in Patients with Crohnʼs Disease and Relapsing Multiple Sclerosis: Updated Utilization and Safety Results from the TOUCH,TM Prescribing Program, the Pregnancy Registry, and the INFORM and TYGRIS Studies

Abstract

Purpose: To report the most recent data on natalizumab utilization and safety in patients with Crohn's disease (CD) and relapsing multiple sclerosis (MS). Methods: Natalizumab was approved by the FDA for use in CD in 2008. The TYSABRI Outreach: Unified Commitment to Health (TOUCHTM) Prescribing Program, CD INFORM: Investigating Natalizumab through Further Observational Research and Monitoring, TYSABRI Global ObseRvation Program In Safety (TYGRIS), and pregnancy registry are ongoing risk management programs or studies designed to further evaluate the safety of natalizumab. TOUCHTM is a mandatory prescribing program for all patients, physicians, and infusion centers in the United States that ensures appropriate and informed use of natalizumab. The purpose of TOUCHTM is to monitor patients for serious opportunistic infections (OIs), including progressive multifocal leukoencephalopathy (PML). CD INFORM is a voluntary study in the United States collecting patient history, efficacy as assessed by the Harvey Bradshaw Index (HBI), Health Related Quality of Life outcomes, and serious adverse events (SAE) in CD patients. TYGRIS is a voluntary global observational study evaluating the long-term safety of natalizumab in MS. Post-marketing surveillance data from countries that do not participate in TOUCHTM or TYGRIS are also collected. This abstract provides updates on natalizumab utilization and safety data from these programs in both indications. Results: As of the end of March 2010, ˜67,700 patients have been exposed to natalizumab in the post-marketing setting, predominately for MS. As of 6 May 2010, 49 confirmed cases of PML had been reported in the post-marketing setting (all in MS patients). There were 11 deaths; 38 of the 49 (78%) natalizumab-treated patients who developed PML have survived and exhibit varying levels of disability. CD INFORM has enrolled 84 patients with an average HBI at time of entry of 8.3 as of 23 May 2010. Of the 51 CD patients with an HBI assessment following 6 months of natalizumab therapy, the average score was 4.7, a mean decrease of 2.8 points from baseline. The overall SAE incidence in CD INFORM was 16.7% (n=14), though only 2.4% (n=2) was considered treatment related. As of 23 February 2010, there were 198 women (including 1 woman with CD) enrolled prospectively in the pregnancy registry where the outcome of the pregnancy was unknown at time of enrollment. Follow-up was ongoing in 51 cases and 151 outcomes have been reported (4 patients with twins resulted in 2 outcomes for each pregnancy). The most current exposure and safety data from patients receiving natalizumab worldwide will be presented. Conclusion: Cumulative data from both indications suggest a safety profile consistent with the product labeling of natalizumab. Disclosure: Drs Anthony Pepio and Lori Taylor are employees of Elan Pharmaceuticals, Inc. Drs Mariska Kooijmans, Lynda M. Cristiano, and Carmen Bozic are employees of Biogen Idec, Inc. Dr Grainne Quinn is an employee of Elan Pharma International Ltd.