Natalizumab Induction Therapy Results in Improved Quality of Life in Patients with Crohnʼs Disease

Abstract

Purpose: To investigate quality of life (QoL) outcomes during ENCORE, a phase 3, randomized, double-blind, placebo (pbo)-controlled trial evaluating the efficacy and safety of natalizumab (NAT) induction therapy in patients (pts) with Crohn's disease (CD). Methods: Pts with Crohn's Disease Activity Index (CDAI) scores ≥ 220 and ≤ 450 and C-reactive protein (CRP) levels >2.87 mg/L were randomized 1:1 to receive 300 mg NAT (n = 259) or placebo (pbo) (n = 250) infusions at Weeks (wks) 0, 4, and 8. The Inflammatory Bowel Disease Questionnaire (IBDQ) and Short Form-36 (SF-36) were used to measure QoL at baseline and Wk 12. Higher scores indicate better QoL. Results: Baseline scores were comparable between the 2 groups. Pts in the NAT group had a mean CDAI score of 303.9 and a mean IBDQ total score of 123.6 vs 299.5 and 122.5 respectively, in the pbo group. At Wk 12, improvement in mean total IBDQ score was greater for pts in the NAT group compared to pbo (26.7 vs 15.1, respectively, p < 0.001), as was improvement in all 4 dimensions of the IBDQ (p≤ 0.002). Improvement in 6 of the 8 individual scale scores of the SF-36 (p≤ 0.013), as well as the physical score component (PCS) score (p < 0.001), was greater in pts receiving NAT. Conclusions: Pts receiving NAT induction therapy had significantly greater improvements in QoL than those receiving pbo, as measured by both disease specific (IBDQ) and global (SF-36) measures of QoL. Greater improvements were seen in the total IBDQ, all IBDQ subscale scores, 6 of 8 SF-36 scales, and the PCS scale of the SF-36.Table: QoL Score Change from Baseline to Wk 12-Mean (SD).