TOUCH™ Study Patient Outcomes: The Impact of Natalizumab on Utilization of Healthcare Resources by the Patients and Their Associated Treatment Satisfaction

Abstract

Purpose: Natalizumab (NAT) is approved for the treatment of moderate to severe Crohn's disease (CD) in patients who have had an inadequate response to or are unable to tolerate conventional and anti-TNF therapies. In this naturalistic treatment experience study, the impact of NAT on a variety of outcomes is evaluated. Methods: The study sample was comprised of patients enrolled in the Tysabri Outreach: Unified Commitment to Health (TOUCH™) prescribing program that were appraised of the project and agreed to study participation. Subjects completed online or phone surveys regarding their prior biologic history, steroid use, complications over the past 3 months and healthcare utilization. Patients also completed the Treatment Satisfaction Questionnaire for Medicines (TSQM) which measures their satisfaction with treatment effectiveness, side-effects and convenience, and global treatment satisfaction. Data were collected prior to the initiation of NAT therapy and at month 3 of treatment. Results: To date, forty-nine patients have provided baseline data. Females comprised 59% of the sample, and they had a mean age of 41 years and mean time from diagnosis of 13 years. Ninety-four percent of the patients reported prior biologic use, 88% had used infliximab; 65% had used adalimumab and 20% had used certolizumab. Overall, 24% of patients had used one anti-TNF, while 59% had used 2 anti-TNFs and 10% had used all 3 anti-TNFs. Sixty-nine percent of patients reported steroid use in the past 3 months, while the mean number of hospital admissions, days in hospital, and emergency room (ER) visits due to CD and days of total parenteral nutrition during the same time period were 0.8, 6.6, 1.4 and 5.8, respectively. Among the 16 patients providing month 3 data, there was a significant decrease in the number of CD-related ER visits (1.4 vs. 0.6 p=0.032) and the percent of patients with CD-related complications (abscess, fistula, ostomy, obstruction (56.2% vs. 31.2% p=0.041). Significant improvements were observed in each of the four scales of the TSQM at follow-up (Effectiveness Scale 26.0 vs. 65.6 p<0.001; Side-effects Scale 56.8 vs. 87.5 p=0.002, Convenience Scale 61.8 vs. 71.9 p=0.032; Global Satisfaction Scale 35.9 vs. 69.8 p<0.001). Conclusion: NAT therapy was found to be associated with significant improvements in treatment satisfaction compared to previous therapy. Healthcare utilization during the 3 months prior to study start was high. Patients reported significantly lower complications and ER visits while they were on NAT therapy. Disclosure: Dr Kane reports having received Grant/Research Support and serving as an Advisory Committee/Board Member to Elan and Biogen Idec; Dr Panaccione reports serving as a consultant and an Advisory Committee/Board Member to Elan and Biogen Idec; Dr Colombel reports serving as a consultant and an Advisory Committee/Board Member to Elan and Biogen Idec; Dr Sands reports serving as a consultant and an Advisory Committee /Board Member to Elan and Biogen Idec; Dr Rubin reports serving as a consultant and an Advisory Committee/Board Member to Elan and Biogen Idec; Dr Lewis reports serving as a consultant and an Advisory Committee/Board Member to Elan and Biogen Idec; Dr Hass, Ms. Nag and Mr. Panjabi are employees of Elan. These studies are supported by Elan Pharmaceuticals, Inc. and Biogen Idec, Inc.