Shorter Disease Duration Is Associated With Higher Rates of Response to Vedolizumab in Patients With Crohn’s Disease But Not Ulcerative Colitis

Abstract

BACKGROUND & AIMS:Patients with Crohn's disease (CD), but not ulcerative colitis (UC), of shorter duration have higher rates of response to tumor necrosis factor (TNF) antagonists than patients with longer disease duration. Little is known about the association between disease duration and response to other biologic agents. We aimed to evaluate response of patients with CD or UC to vedolizumab, stratified by disease duration. METHODS:We analyzed data from a retrospective, multicenter, consortium of patients with CD (n [ 650) or UC (n [ 437) treated with vedolizumab from May 2014 through December 2016. Using time to event analyses, we compared rates of clinical remission, corticosteroid-free remission (CSFR), and endoscopic remission between patients with early-stage (£2 years duration) and later-stage (>2 years) CD or UC. We used Cox proportional hazards models to identify factors associated with outcomes. RESULTS:Within 6 months initiation of treatment with vedolizumab, significantly higher proportions of patients with early-stage CD, vs later-stage CD, achieved clinical remission (38% vs 23%), CSFR (43% vs 14%), and endoscopic remission (29% vs 13%) (P < .05 for all comparisons). After adjusting for disease-related factors including previous exposure to TNF antagonists, patients with early-stage CD were significantly more likely than patients with later-stage CD to achieve clinical remission (adjusted hazard ratio [aHR], 1.59; 95% CI, 1.02-2.49), CSFR (aHR, 3.39; 95% CI, 1.66-6.92), and endoscopic remission (aHR, 1.90; 95% CI, 1.06-3.39). In contrast, disease duration was not a significant predictor of response among patients with UC. CONCLUSIONS:Patients with CD for 2 years or less are significantly more likely to achieve a complete response, CSFR, or endoscopic response to vedolizumab than patients with longer disease duration. Disease duration does not associate with response vedolizumab in patients with UC.

Systematic review and meta‐analysis: efficacy and safety of early biologic treatment in adult and paediatric patients with Crohn’s disease

“…In a long‐term follow‐up of an RCT, significantly higher MH rates of 72.0% compared to 28.6% were observed in early versus late/conventional treatment group . Similar trends were observed in five observational studies in a real‐world setting …”

“…In two other post hoc analyses, the CR rates in early versus late treatment groups were 56% vs 58% (n = 945, <2 vs 2‐5 years at 20 weeks, CR was defined as HBI ≤4) and 46% vs 28% (n = 777, <2 vs 2‐≤5 years at 26 weeks) . Two large observational studies reported similar trends in higher remission rates in early versus late/conventional treatment group …”

“…Eight studies reported higher clinical remission rates (Table 3) with early treatment (38%‐81.5%) versus late/conventional treatment (14%‐80%) . In an RCT, the CR rates for early versus late/conventional were 60.6% vs 35.9% ( P = .0062) .…”

“…Nine publications showed that early treatment leads to better mucosal healing rates (29.0%‐72.0%) compared with late/conventional treatment (12.9%‐62.2%) . In an RCT the rate of mucosal healing was 45.9% vs 30.3% (n = 244, P = .010) in tight control vs conventional treatment group .…”

“…Eight publications reporting clinical remission in adult and paediatric patients were included for meta‐analysis. Overall higher rates of CR at 26‐52 weeks ranged from 48% to 78% in early biologic treatment compared with 35% to 57% for late or conventional management or step‐up (Figure 2).…”