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

Abstract

Natalizumab (NAT) is an integrin receptor antagonist indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn's disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-α. The study sample was comprised of patients enrolled in the TYSABRI Outreach: Unified Commitment to Health (TOUCH®) prescribing program that agreed to study participation. Patients 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; 2 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. Sixty-one patients have provided baseline data (females = 61%, mean age = 42 years, mean time from diagnosis = 13 years). At baseline, the mean total IBDQ was 112; the SF-36 PCS was 29 and the MCS was 37 (US general population mean = 50). A significant change of 32 points on the total IBDQ scale (p≤0.001) was noted among the 24 patients who completed the 3-month followup. Significant improvements in each of the four component scales were also seen (p≤0.01). Improvements on each of the IBDQ scales were clinically meaningful. Significant improvement was noted on the SF-36 PCS scale (mean change 7.0, P = 0.001) 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 (3.4 vs. 2.4, P < 0.006) and similar results were observed regarding their assessment of the impact of CD on QOL (6.2 vs.4.3, P < 0.001). Some of these patients experienced large and meaningful improvement in QOL after 3 months of therapy.