Second anti-TNF ‘reasonable option’ for UC, whether infliximab or subcutaneous agent
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Key takeaways:
- Use of a second anti-TNF — IV or subcutaneous agent — resulted in early response and long-term remission among patients with ulcerative colitis.
- Efficacy was reduced with failure to the first anti-TNF.
Use of a second anti-tumor necrosis factor agent resulted in early clinical response in nearly 50% of patients with ulcerative colitis and long-term remission in about 30%, with no difference reported between IV and subcutaneous agents.
“Recently, a retrospective French study comparing the efficacy of [infliximab] and vedolizumab in clinical practice as second-line therapies after the failure of a subcutaneous anti-TNF found a higher treatment persistence for vedolizumab,” Margalida Calafat, PhD, MD, of the department of gastroenterology at Germans Trias i Pujol University Hospital, and colleagues wrote in Therapeutic Advances in Gastroenterology. “The authors suggested that the change in the mechanism of action may be the best therapeutic option after failure or intolerance to a subcutaneous anti-TNF in patients with UC.”
They continued: “In this study, we aim to compare the clinical and treatment outcomes of a second subcutaneous or intravenous anti-TNF in UC patients.”
In a retrospective, observational study, Calafat and colleagues used the ENEIDA registry to identify 473 patients with UC, who had been treated with both IV and subcutaneous anti-TNF agents and were naive to other biologics. Researchers grouped patients according to whether they received the first anti-TNF via IV (n = 330) or subcutaneous (n = 143) administration.
The studied outcomes of a second anti-TNF included clinical response and remission at weeks 14 and 52 as well as secondary loss of response, dose escalation and treatment persistence.
According to results, most patients (90%) in the IV group were first treated with Remicade (infliximab, Janssen) vs. the biosimilar CT-P13 (10%), while a greater number of patients in the subcutaneous group were treated with adalimumab (57%) vs. golimumab (43%).
The second anti-TNF in the IV group was more often adalimumab (83%) than golimumab (17%), while patients in the subcutaneous group were similarly divided between CT-P13 (53%) and the infliximab originator (47%).
For the entire cohort, clinical response and remission rates to the second anti-TNF were 44.4% and 29.2%, respectively, at week 14 and 38.5% and 32.4% at week 52. Though not statistically significant, those rates were 42.7% and 30.3%, respectively, at week 14 for the IV group and 48.3% and 26.6% for the subcutaneous group. At week 52, rates were 37.5% and 32.8%, respectively, for the IV group and 40.7% and 31.4% for the subcutaneous group.
Researchers noted, however, that patients in the IV group had longer treatment persistence and longer dose escalation-free survival, both of which were statistically significant.
Of 164 patients who did not achieve remission with the first anti-TNF, those in the IV group had a “significantly lower proportion” of secondary loss of response (13% vs. 29%) as well as longer dose escalation-free survival. Among 171 patients who experienced loss of response to the first anti-TNF, those in the subcutaneous group demonstrated a “significantly higher” rate of clinical response at week 14 (66% vs. 41%) but shorter treatment persistence.
Propensity-matched score analysis of 121 pairs from both groups confirmed a “statistically significant” higher rate of clinical response at week 14 among those in the subcutaneous group (50.4% vs. 34.7%).
“We report a good short- and long-term efficacy of a second anti-TNF for UC, although it is reduced in cases of primary failure of the first anti-TNF and more severe disease activity,” Calafat and colleagues wrote. “Efficacy does not seem to change whether the second anti-TNF is [infliximab] or a subcutaneous agent, and only a longer persistence of the second anti-TNF was observed when the first agent was [infliximab].”
They concluded: “Prescribing a second anti-TNF in UC remains a reasonable option but face-to-face controlled trials comparing a second anti-TNF to other selective immunosuppressants should be performed, particularly in the case of primary failure of a first anti-TNF.”
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