Adalimumab versus ustekinumab as first-line biological in moderate-to-severe Crohn’s disease: real-life cohort from a tertiary referral center

Abstract

Background Therapeutic options for Crohn’s disease are growing, making the choice of first-line therapy relevant. Both adalimumab and ustekinumab are effective in moderate-to-severe Crohn’s disease. The Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year trial suggested no difference in clinical or endoscopic remission at week 52 in biological-naive Crohn’s disease patients. We explored if results withstand in the real world. Methods We included bio-naive Crohn’s disease patients starting adalimumab or ustekinumab between 2017 and 2020. Patients had endoscopy-proven moderate-to-severe disease [Simple Endoscopic Score for Crohn’s disease (SES-CD) ≥3]. Clinical remission was defined as Harvey Bradshaw Index (HBI) <5 or physician global assessment. Endoscopic remission (SES-CD <3) and improvement (≥50% reduction in SES-CD from baseline) were assessed at W26-52. Propensity score matching was used. Results A total of 68 biological-naive Crohn’s disease patients were included (32 adalimumab and 32 ustekinumab) and followed for median of (IQR) 60 (33–104) weeks. Patients had significantly higher odds of achieving endoscopic remission with adalimumab than ustekinumab [adjusted odds ratio (aOR), 2.73; confidence interval (CI), 1.12–7.36; P = 0.03]. Also, more adalimumab-treated patients achieved endoscopic response, clinical remission at week 26 and 52 (aOR, 2.24; CI, 0.94–5.71; P = 0.07; aOR, 1.26; CI, 0.36–4.51; P = 0.72; aOR, 1.58; CI, 0.54–4.88; P = 0.41, respectively). Treatment persistence was not different between groups (P = 0.44). The number of adverse events was similar. Conclusion In a real-world cohort of biological-naive Crohn’s disease patients, adalimumab was superior to ustekinumab in achieving endoscopic remission. No differences in clinical remission at W26-52 or treatment persistence were observed. Both adalimumab and ustekinumab remain good options as first-line biologicals in moderate-to-severe Crohn’s disease.

Meta‐analysis: Persistence of advanced therapies in the treatment of inflammatory bowel disease

“…Among the 63 publications, 10‐72 58 were journal articles and 5 were international conference abstracts. Two conference abstracts 71,72 were replaced by subsequent published articles found in our search.…”

Ustekinumab in the Treatment of Inflammatory Bowel Diseases: Evolving Paradigms

“…Zhdanava et al reported that, at 12 months, bio-naïve UST-treated CD patients showed a significantly higher treatment persistence rate than ADA-treated CD patients [ 85 ]. On the other hand, a Belgian study was unable to detect differences in the clinical remission rate between ADA and UST bio-naïve CD patients at week 26 (adjusted odd ratio [aOR] 1.30; p = 0.72) and at week 52 (aOR, 1.60; p = 0.41) [ 86 ].…”

“…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 , …”

Comparison of Effectiveness and Safety of Ustekinumab and Adalimumab As Induction or Maintenance Therapy in Patients With Moderate to Severe Crohn's Disease: A Systematic Review and Meta-Analysis

“…Moens et al [ 13 ] reported no significant difference between the two groups in terms of adverse events (24 in each group) within the first year of treatment. No serious infections were reported nor were any death reported in any of the two groups.…”

“…The most common adverse event reported by Sands et al [ 14 ] was infection in 34% and 41% of the ustekinumab and adalimumab groups respectively. Moens et al [ 13 ] reported that in any eight events of infections in ustekinumab and 10 events of infections in adalimumab groups.…”