A greater proportion of biologic-naive patients with moderate to severe ulcerative colitis (UC), treated with infliximab, achieved clinical remission (CR) at week 8 compared with those treated with tofacitinib, according to a study in Digestive Diseases and Sciences.
The findings are from a post hoc analysis of data from biologic-naive patients with moderate to severe UC from 4 clinical trials (ACT-1, ACT-2, OCTAVE-1, and OCTAVE-2; ClinicalTrials.gov Identifier: NCT00096655, NCT00096655, NCT01465763, NCT01458951, respectively).
Researchers compared patients who were treated with standard-dose induction therapy with tofacitinib (10 mg orally twice daily for 8 weeks) with those who received infliximab (5 mg/kg intravenously at weeks 0, 2, and 6).
The primary outcome was clinical remission (CR) at week 8, based on a total Mayo score less than or equal to 2 with a stool frequency subscore less than or equal to 1 and not greater than baseline, rectal bleeding subscore of 0, and Mayo endoscopic subscore less than or equal to 1.
In ACT-1 and ACT-2, 242 biologic-naive participants (mean [SD] age, 41.4[13.3] years; men, 64%) were treated with infliximab 5 mg/kg and were included in this post hoc analysis. From OCTAVE-1 and OCTAVE-2, 417 biologic-naive patients (mean age, 41.1[13.5] years; men, 60%) treated with tofacitinib 10 mg bid were included. Participants treated with infliximab had a shorter disease duration (mean 4.7[4.5] years vs 7.2[6.7] years, P = .001], compared with those treated with tofacitinib.
A greater proportion of patients treated with infliximab achieved CR at week 8 (36.4% vs 24.0%; P = .001) vs those who received tofacitinib. The odds of achieving CR at week 8 with infliximab continued to be significantly improved after adjustment for covariates (adjusted odds ratio [aOR], 1.65; 95% CI, 1.11-2.44; P = .013).
At week 8, the rate of endoscopic improvement also was significantly greater in patients who received infliximab (61.6% vs 38.1%; P <.001). This finding remained significant after adjustment (aOR, 2.12; 95% CI, 1.45-3.10; P <.001). Comparable findings were observed for endoscopic remission (25.2% vs 10.3%; aOR, 2.72; 95% CI, 1.66-4.46; P <.001).
Propensity score matching was used to identify patients with more balanced baseline covariates, which included 231 patients treated with tofacitinib and 231 treated with infliximab. In this cohort, compared with patients who were treated with tofacitinib, those treated with infliximab were significantly more likely to achieve CR at week 8 (36.6% vs 22.9%; aOR, 1.89; 95% CI, 1.20-2.98; P = .006), endoscopic improvement (61.2% vs 39.7%; aOR, 2.26; 95% CI, 1.45-3.10; P <.001), and endoscopic remission (26.0% vs 10.1%; aOR, 2.94; 95% CI, 1.66-5.22; P <.001).
For clinical response at week 2, similar proportions of patients treated with infliximab vs tofacitinib achieved this outcome (84.7% vs 80.1%; P = .139]. No significant difference was observed in the odds of achieving clinical response after adjustment for covariates (aOR, 1.48; 95% CI, 0.93-2.37; P = .101). The findings were similar for this outcome in the propensity score-matched cohort (85.9% vs 77.1%; aOR, 1.55; 95% CI, 0.92-2.61; P = .102) and with inverse probability-weighted regression adjustment.
Limitations include the inability to completely eliminate baseline characteristic mismatches. In addition, the infliximab group had a significantly higher C-reactive protein level, shorter disease duration, and percentage of Caucasian patients, all of which could affect treatment response.
“Although this analysis did not consider safety or cost, consideration should be given to using infliximab over tofacitinib for the treatment of moderate to severe UC among biologic-naïve patients based on the efficacy observed in this study,” the study authors wrote.
Disclosure: This research used data associated with Janssen Research & Development, LLC and with Pfizer made available through Vivli, Inc. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Wong ECL, Merat S, Monaco C, et al. Comparative efficacy of infliximab vs tofacitinib for inducing remission in biologic naive ulcerative colitis: a propensity matched study. Dig Dis Sci. Published online April 29, 2023. doi:10.1007/s10620-023-07956-8