‘Do not give up too early’: Early nonresponders with IBS-C improve on Ibsrela at 12 weeks
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Key takeaways:
- Nearly 80% of patients with irritable bowel syndrome and constipation improved with tenapanor at 12 weeks.
- The median time to a reduction in abdominal bloating with tenapanor was 5 weeks.
VANCOUVER, British Columbia — Continued Ibsrela therapy for 12 weeks enabled early nonresponders with irritable bowel syndrome and constipation to achieve a meaningful response, noted a presenter at the ACG Annual Scientific Meeting.
“This study was really driven by clinicians asking the simple question: How long should I have my patients try tenapanor before I decide it may not work?” Brian E. Lacy, MD, PhD, FACG, professor of medicine at the Mayo Clinic in Jacksonville, Florida, told Healio. “We know from prior studies in patients with IBS and constipation — the T3MPO-1 and T3MPO-2 studies — that many patients with IBS and constipation noted an improvement in abdominal pain and constipation symptoms quite quickly, usually within the first 1-2 weeks. However, not all patients respond so quickly.”
He added: “If health care providers do not provide an adequate therapeutic trial for all patients with IBS and constipation, it is quite possible that they will miss out on many patients who might respond to this FDA-approved medication, but not quite as quickly as other patients.”
To investigate the time until Ibsrela (tenapanor, Ardelyx) responses were observed in IBS-C, including complete spontaneous bowel movements and reduction in abdominal pain and abdominal bloating, Lacy and colleagues conducted a post-hoc analysis of pooled data from three T3MPO-1/T3MPO-2 studies. Based on data from the first 12 weeks of treatment, the researchers used the Kaplan-Meier method to assess time to response among 684 patients who received twice-daily tenapanor 50 mg and 688 patients in the control group.
According to study results, the median time for complete spontaneous bowel movement response among patients treated with tenapanor was 2 weeks with an estimated response probability of 52.3%. The researchers reported an estimated response probability of 72.5% at week 8 and 76.7% at week 12.
“The most important finding was that, at the end of 12 weeks, 77% of patients reported an improvement in complete spontaneous bowel movements,” Lacy told Healio. “This shows that, by continuing therapy for a longer period of time, up to 25% more patients will note an improvement in their IBS with constipation symptoms.”
The researchers also observed that the median time to reduction in abdominal bloating was 5 weeks, with an estimated probability of 48.1% at week 4, 61.9% at week 8 and 67.7% at week 12.
“Although bloating is not a key criterion for the diagnosis of IBS with constipation in the Rome IV criteria, it is present in up to 70% of patients with IBS and is a difficult-to-treat symptom,” Lacy said.
Similarly, the researchers reported that the median time to reduction in abdominal pain was 4 weeks, with an estimated response probability of 54.6%; they noted an estimated response probability was 67.9% at week 8 and 72.3% at week 12.
“This study confirms earlier studies demonstrating that tenapanor is effective at relieving global IBS and constipation symptoms — in addition it is quite safe,” Lacy told Healio. “Tenapanor has a unique mechanism of action [which] means that patients who may not have responded to other therapies used to treat IBS-C symptoms may respond to this novel agent.”
He added: “The bottom line from this study is not to give up too early when treating IBS-C patients with tenapanor. Some patients respond later than the first 2 weeks of therapy; if a patient has not responded immediately, do not give up too early and make sure that each patient receives an adequate therapeutic trial.”
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Lacy BE, et al. Tenapanor treatment success for IBS-C symptoms increases with duration of therapy. Presented at: ACG Annual Scientific Meeting; Oct. 20-25, 2023; Vancouver, British Columbia (hybrid meeting).
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