Natalizumab use in patients with Crohn's disease and relapsing multiple sclerosis: Updated utilization and safety results from the touch™ prescribing program, the pregnancy registry, and the inform and TYGRIS studies

Purpose: To report the most recent data on natalizumab utilization and safety in patients with Crohn's disease (CD) and relapsing multiple sclerosis (MS). Background: Natalizumab, an alpha-4-integrin receptor antagonist, was approved by the FDA for use in CD in January 2008. The TYSABRI Outreach: Unified Commitment to Health (TOUCH™) Prescribing Program, CD INFORM: Investigating Natalizumab through Further Observational Research and Monitoring, TYSABRI Global ObseRvation Program In Safety (TYGRIS), and pregnancy registry are all ongoing risk management programs and studies designed to further evaluate the safety and efficacy of natalizumab. TOUCH™ is a mandatory prescribing program for all patients, physicians, and infusion centers in the United States (US) that ensures appropriate and informed use of natalizumab. The purpose of TOUCH™ is to monitor patients for signs and symptoms of progressive multifocal leukoencephalopathy (PML), and to assess the incidence of serious opportunistic infections (OIs) associated with natalizumab. CD INFORM is a voluntary observational study in the US collecting patient history, efficacy as assessed by the Harvey Bradshaw Index, Health Related Quality of Life outcomes, and serious adverse events in CD patients. TYGRIS is a voluntary global observational study evaluating the longterm safety of natalizumab in MS. Post-marketing surveillance data is also collected from all countries where natalizumab is approved. This abstract provides updates on natalizumab utilization and safety data from these programs in both indications. Results: As of the end of September 2009, approximately 60,700 patients have been exposed to natalizumab in clinical study and post-marketing settings (∼95% were MS patients), constituting 74,800 patient-years of exposure. Additionally, more than 34,000 patients have received at least 1 year, and more than 13,000 have received more than 2 years, of therapy. In the postmarketing setting, additional cases of PML have been reported in MS patients who were receiving no concomitant immunomodulatory therapy. In patients treated with natalizumab, the risk of developing PML increases with longer treatment duration, and for patients treated for 24 to 36 months is generally similar to the rates seen in clinical trials. There have been 424 reports of pregnancy and 185 women enrolled in the registry as of the end of August 2009. The most current exposure and safety data from patients receiving natalizumab worldwide will be presented. Conclusions: Cumulative data from both indications and associated registries and studies suggest a safety profile similar to that observed in clinical studies of natalizumab.