Long-term treatment with plecanatide was safe and tolerable in patients with irritable bowel syndrome with constipation

Abstract

Objective: This open-label, multi-center, fixed-dose study (NCT02706483) evaluated the long-term safety and tolerability of plecanatide for the treatment of adults with irritable bowel syndrome with constipation (IBS-C).

Methods: Safety and tolerability of once-daily plecanatide 6 mg for up to 53 weeks was assessed in patients with IBS-C who either had been enrolled in one of the phase 3 studies or were study-naïve but met eligibility criteria of the double-blind studies. Safety was assessed by treatment-emergent adverse events (AEs). Patient-reported questionnaires assessed overall IBS symptoms, treatment satisfaction, and desire for treatment continuation. No dose adjustments or treatment interruptions were permitted during the study.

Results: Of the 2272 patients enrolled, 1842 (81.1%) completed the study. AEs were experienced by 27.3%, and 4.3% discontinued due to an AE. Most AEs were mild or moderate (90.3%). The incidence of diarrhea, the most commonly reported AE, was low (6.7%), and declined in frequency over time. Diarrhea was the most common cause of AE-related withdrawals (2.7% of patients). At week 53 or end of treatment, 88.2% of patients reported “significant” or “moderate” relief, 72.4% were “very” or “quite” satisfied with treatment, and 76.6% were “very” or “quite” likely to continue treatment.

Conclusions: Plecanatide 6 mg was safe and well tolerated in patients with IBS-C treated for up to 53 weeks, with an overall safety profile similar to the 12-week IBS-C studies. Patients reported high rates of relief and satisfaction with treatment, and interest in continuing therapy.

Trial registration: ClinicalTrials.gov identifier: NCT02706483.

Keywords:

• Plecanatide
• Irritable bowel syndrome with constipation
• Long-term
• Safety
• Tolerability

Declaration of financial/other relationships

CFB has participated in studies with plecanatide and was paid by Synergy Pharmaceuticals Inc. as a principal investigator. RAC and PHG are employees and own stock options of Synergy Pharmaceuticals Inc. CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Previous presentation

Digestive Disease Week^® 2018; Washington, DC; June 5–8, 2018 (poster Su1192).

Acknowledgments

Medical writing and editorial support were provided by Nicole Coolbaugh and Ann Sherwood, PhD with The Medicine Group (New Hope, PA).