P Riviere et al. Inflamm Bowel Dis 2023; 29: 923-931. 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

A previous study (SEAVUE) has suggested similar efficacy of ustekinumab and adalimumab in biologic-naive patients (post: SEAVUE: Head-to-Head Ustekimumab vs. Adalimumab) with ~60-65% clinical response at 52 weeks and ~30% endoscopic remission.

This current retrospective study sought to obtain ‘real-world’ data comparing anti-TNF agents (95 adalimumab, 61 infliximab) to ustekinumab (n=50). In the anti-TNF group, 44% (n=68) received concomitant immunomodulator therapy. Key findings:

•  At 3 months, clinical response rates were 86% in anti-TNF groups and 64% in the ustekinumab.
• At 12 months, in adjusted multivariate analysis, clinical remission (based on Harvey-Bradshaw Index) was independently associated with the biological therapy received (odds ratio, 2.6 for anti-TNF agent vs ustekinumab; P = .02).
• “In our sensitivity analysis, a significant difference in terms of efficacy was only found between infliximab and ustekinumab.”
• In those with ileocolonoscopy, endoscopic healing was similar (between 6-18 months): 58% of anti-TNF group and 61% of ustekinumab group.
• 2% of patients in the anti-TNF group had severe adverse events compared to none in the ustekinumab group; among patients receiving adalimumab, 1 patient had cerebral aspergillosis, 1 had a postinfectious macrophage activation syndrome, and 1 had severe folliculitis needing abscess drainage.
• Drug persistence at 12 months was 87% in anti-TNF group and 88% in ustekinumab group.

The discussion notes that ‘real-world’ data is important as only ~30% of patients in a regular practice would fulfill the criteria to be included in clinical trials. However, in this retrospective (non-randomized) study, there were differences in the patient population that could affect response to treatment, including a higher rate of smokers in the anti-TNF group (29% compared to 12% in the ustekinumab group).

My take: While anti-TNF therapy, particularly infliximab, may be a little better based on clinical remission, the most objective marker of efficacy, endoscopic healing, was similar. Thus, it is not clear if anti-TNF therapy is more effective than ustekinumab. To achieve optimal results, many in the anti-TNF group received immunomodulator cotherapy and dose escalation.

Related blog posts:

• Why Do Children Taking Adalimumab Benefit from Methotrexate Dual Therapy?
• According to the study which you would never qualify for…
• SEAVUE: Head-to-Head Ustekimumab vs. Adalimumab

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