Originally published by 2 Minute Medicine® (view original article). Reused on AccessMedicine with permission.

1. Clinical remission at 52 weeks was similar between ustekinumab and adalimumab.

2. Patient-reported outcomes of stool frequency and abdominal pain scores were lower in the ustekinumab group compared to adalimumab (p=0.019).

Evidence Rating Level: 1 (Excellent)

Study Rundown:

First-line treatment for Crohn’s disease includes steroids, immunomodulators, and biologics. TNF inhibitors and interleukin (IL)-12 and IL-23 inhibitors represent more potent biologic options that work at the molecular level. Ustekinumab, an IL-12 and IL-23 agent, and adalimumab, anti-TNF antibody, have both shown superiority over placebo in previous trials. However, whether one biologic is more effective than the other is not well known. This randomized controlled trial aimed to compare the safety and efficacy of two relatively novel monoclonal antibodies, ustekinumab and adalimumab, in patients with moderate-to-severe active Crohn’s disease. The primary outcome was the proportion of patients in clinical remission, defined by Crohn’s Disease Activity Index (CDAI) score <150, a year after randomization. According to study results, clinical remission at 52 weeks was not significantly different between the ustekinumab and adalimumab groups. Serious and overall adverse events were also similar between groups. A major limitation of this study was that data was only reported for up to one year from baseline. Given that Crohn’s is a chronic disease, a longitudinal assessment may be warranted.

Relevant Reading: Ustekinumab as Induction and Maintenance Therapy for Crohn’s Disease

In-depth [randomized-controlled trial]:

From Jun 28, 2018, and Dec 12, 2019, 633 patients were assessed for eligibility across 121 hospitals in 18 countries. Included were patients ≥18 years of age with CDAI score between 220-450 with no response or contraindication to conventional therapy. Altogether, 386 patients (191 in ustekinumab and 195 in adalimumab) were included in the intention-to-treat analysis. The primary outcome of clinical remission was not statistically significant between treatment groups at week 52 (65% in ustekinumab vs. 61% in adalimumab, 95% confidence interval [CI] -6 to 14, p=0.42). The same was true for safety with 2% (4 of 191) patients in ustekinumab group reporting serious infections compared to 3% (5 of 195) in adalimumab group. Overall, findings from this study suggest that while both ustekinumab and adalimumab are both effective for treatment of moderate to severe active Crohn’s disease, no clinical difference in safety and efficacy was seen between the two after 52 weeks.

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