TOUCH™ Study Patient Outcomes: The Impact of Natalizumab on Common Measures of Quality of Life in CD patients

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 who agreed to study participation. Subjects completed online or phone surveys containing two validated measures of health-related quality of life (QOL), the Short-Inflammatory Bowel Disease Questionnaire (SIBDQ) and SF-12. The scales comprising the SIBDQ and their clinically meaningful differences (CMD) are bowel (5) and systemic (2.5) symptoms and social (2.5) and emotional function (6). The SF-12 is comprised of 8 scales; two summary scales (Physical Component Summary [PCS] and Mental Component Summary [MCS]) can be computed. The CMD of each SF-12 scale is 5 pts. The scales of the SIBDQ and SF-12 are converted to their more familiar IBDQ and SF-36 scores. Patients also completed global assessments of QOL and of the impact of CD on QOL. Data were collected at baseline and at month 3 of treatment. Results: Forty-nine patients have provided baseline data (females=59%, mean age=41 years, mean time from diagnosis=13 years). At baseline, the mean total IBDQ was 116; the SF-36 PCS was 30 and the MCS was 38 (US general population mean=50). A significant change of 39.2 points on the total IBDQ scale (p≤0.001) was noted among the 16 patients who completed the 3 month follow-up. Significant improvements in each of the four component scales were also seen (p≤0.006). The improvements on each of the IBDQ scales also were clinically meaningful. Significant improvement was also noted on the SF-36 PCS scale (mean change 7.7, p=0.003) and 5 of the 8 individual scales of the SF-36 (p<0.05). The mean change on each scale of the SF-36, including those not reaching statistical significance, was clinically meaningful. The patient global assessment of QOL over the last 2 weeks was significantly higher at follow-up (2.4 vs. 3.6 p<0.001) and similar results were observed regarding their assessment of the impact of CD on QOL (6.5 vs.4.0 p<0.001). Conclusion: Patients initiating NAT therapy have poor QOL that significantly improved after 3 months of therapy. This conclusion is supported by mean changes in IBDQ scale scores and the majority of SF-36 scales. The observed score changes were clinically meaningful. Two patient global assessments on QOL also indicated the NAT had a significant positive impact on the QOL of CD patients within a span of 3 months. Disclosure: Dr Panaccione reports serving as a consultant and an Advisory Committee/Board Member to Elan and Biogen Idec; Dr Kane reports having received Grant/Research Support and serving as 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 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 Hass, Ms. Nag and Mr Panjabi are employees of Elan and Ms. Debra Eisenberg is an employee of HealthCore, Inc. These studies were sponsored by Elan Pharmaceuticals, Inc. and Biogen Idec, Inc.