Comparative Effectiveness of Ustekinumab and Anti-TNF Agent as First-Line Biological Therapy in Luminal Crohn’s Disease: A Retrospective Study From 2 Referral Centers

Abstract

Background Real-life data on the efficacy of ustekinumab as first-line therapy for the treatment of luminal Crohn’s disease (CD) compared with anti-tumor necrosis factor (anti-TNF) agents are lacking. We compared the clinical response rates at 3 months in 2 cohorts of biologic-naïve patients treated by ustekinumab and anti-TNF agents. Methods Biologic-naïve patients starting either ustekinumab or an anti-TNF agent for luminal CD between 2016 and 2019 in 2 tertiary centers were retrospectively included. The primary endpoint was clinical response at 3 months, defined as a Harvey-Bradshaw Index <4 or a 3-point drop in the score without steroids, need for CD-related surgery, or treatment discontinuation owing to failure or intolerance. Patients treated with ustekinumab were matched to patients receiving anti-TNF agents by a propensity score algorithm. Results We included 156 patients starting anti-TNF agents (95 adalimumab and 61 infliximab) and 50 ustekinumab. After matching, clinical response rates at 3 months were 64% and 86% in the ustekinumab and anti-TNF groups, respectively (P = .01). At 12 months, in multivariate analysis adjusted for disease duration, location, concomitant immunosuppressant and steroids, and symptoms, clinical remission was independently associated with the biological therapy received (odds ratio, 2.6 for anti-TNF agent vs ustekinumab; P = .02). With a median follow-up duration of 40 (interquartile range, 23-52) months, no difference was observed in terms of time to drug withdrawal (P = .29) or safety. Conclusions This retrospective real-world data suggest that an anti-TNF agent as a first-line biological therapy is associated with higher rates of response at 3 months than ustekinumab in patients with CD.

Ustekinumab in the Treatment of Inflammatory Bowel Diseases: Evolving Paradigms

“…In a retrospective study conducted in two tertiary centers, Rivière et al compared UST with anti-TNF-α drugs in bio-naïve CD patients with luminal disease. The results showed that anti-TNF-α as a first-line treatment was more efficient than UST at three months ( p = 0.02), whereas no difference was detected during a 40-month follow-up ( p = 0.29) [ 84 ]. These findings were probably linked to the effect of IFX rather than ADA.…”

“…Other treatments are usually recommended for refractory patients or those with specific contraindications to anti-TNF-α drugs [ 108 ]. The real-life data for the use of UST in this setting are still scarce and limited by small sample sizes and large heterogeneity of therapy protocols/outcome definitions [ 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 35 , 45 , 47 , 48 , 55 , 61 , 62 , 63 , 68 , 69 , 70 , 71 , 72 , 74 , 75 , 76 , 77 , 78 , 79 , 80 , 81 , 82 , 83 , 84 , 85 , 86 , 87 , 88 , 89 , 91 , 92 , 93 , 94 , 95 , 96 , 97 , 98 , 99 , 100 , 101 , …”

“…Other treatments are usually recommended for refractory patients or those with specific contraindications to anti-TNF-α drugs [108]. The real-life data for the use of UST in this setting are still scarce and limited by small sample sizes and large heterogeneity of therapy protocols/outcome definitions [9][10][11][12][13][14][15][16][17][18][19][20][21]35,45,47,48,55,[61][62][63][68][69][70][71][72][74][75][76][77][78][79][80][81][82][83][84][85][86][87][88][89].…”

Comparing the Effects of Anti-TNF Agent and Ustekinumab on Small Bowel Inflammation in Crohn’s Disease: Inverse Probability Weighting With Stabilized Weights of Propensity Scores

“…23 Several reports have compared the efficacy and persistence of using anti-TNF-α antibody agents with anti-IL12/23 antibody agents in treating various conditions. 20 , 24 , 25 However, to date, no study has specifically and accurately compared their effectiveness on small intestinal inflammation. Therefore, we aimed to unravel the factors contributing to the improvement in small intestinal endoscopic scores.…”