Early difference fades
Corticosteroid-free clinical remission at week 12 was observed in 27.7% of patients in the vedolizumab group, rising to 38.6% at week 24 and 37.3% at week 52. Among those given tofacitinib, the rates of clinical remission were 56.9% at week 12, 60.0% at week 24, and 55.4% at week 52.
Propensity score-weight analysis revealed that tofacitinib patients were more likely to achieve corticosteroid-free clinical remission at weeks 12, 24, and 52, compared with those given vedolizumab, at odds ratio of 6.33, 3.02, and 1.86, respectively.
Biochemical remission rates among patients treated with vedolizumab were 25.3% at week 12, 28.9% at week 24, and 22.9% at week 52. For the tofacitinib group, the rates were 40.0%, 36.9%, and 27.7%, respectively. Biochemical remission was defined by C-reactive protein or fecal calprotectin levels.
The likelihood of biochemical remission was again greater with tofacitinib than with vedolizumab, at an odds ratio of 3.27 at week 12, 1.87 at week 24, and 1.81 at week 52.
Combined clinical and biochemical remission was more likely among patients given tofacitinib versus vedolizumab at week 12, at an odds ratio of 5.05, and at week 24, at an odds ratio of 2.11. However, at week 52, the difference was no longer significant, at an odds ratio of 1.17.
The authors note that there was no difference in the rate of infection between the two treatment groups, and the rate of severe adverse events was similar. However, three patients receiving tofacitinib experienced herpes simplex infections, compared with none of those given vedolizumab.
But, compared with the tofacitinib group, patients taking vedolizumab were more likely to discontinue treatment before 52 weeks, primarily because of a lack of response to treatment.
“The present study underlines that both vedolizumab and tofacitinib are relatively safe treatment options in patients with UC in a 12-month period,” the team writes.
‘Interesting’ efficacy data
Approached for comment, Alan C. Moss, MD, a professor of gastroenterology at Boston University School of Medicine, said that the findings are “interesting” for clinicians.
“We have so many treatment options right now, picking one over the other, particularly in patients like this who fail anti-TNF, is very important,” he told this news organization.
While he noted that registry data such as these are usually powered for “one outcome” (either efficacy or safety), “the immediate conclusions that come to mind are that certainly the efficacy of the two drugs in this patient population looks impressive.
“What we do note, though, is over time, as you get longer into the study, they start to become closer in terms of overall remission,” which Dr. Moss said fits with the current understanding that vedolizumab “takes longer to work.”
The take-away lesson from the study is that the short-term efficacy of tofacitinib is “superior,” Dr. Moss said, but, over the medium to long term, vedolizumab “may turn out to be more equivalent.”
Dr. Moss also pointed out that approximately 40% of patients given tofacitinib in the study began with the higher 10-mg twice-daily dose, “which is not the FDA-approved maintenance dose,” and over time about a quarter stayed on the higher dose.
“What that tells us is that, yes, it works faster if you’re using the higher dose, and over time, a certain proportion of these patients needed a higher dose to get these results,” he said.
Consequently, Dr. Moss said that the two treatment groups were not “equivalent” in terms of the doses given relative to normal maintenance dose.
The Initiative on Crohn and Colitis Fellowship is sponsored by AbbVie, Pfizer, Takeda, Celgene, Janssen Pharmaceutica, Teva Pharmaceutical Industries, Cablon Medical, Ferring Pharmaceuticals, Mundipharma, Dr. Falk Pharma, Sandoz, and Tramedico. Dr. Duijvestein has relationships with Echo Pharma, Robarts Clinical Trials, Janssen, Merck, Pfizer, Takeda, Tillotts Pharma, and Dr. Falk Pharma. Other authors have numerous relationships with industry. Dr. Moss has relationships with Pfizer and Janssen.
A version of this article first appeared on Medscape.com.
