DDW 2017. 263. INTESTINAL, NON-INTESTINAL, AND EXTRA-DIGESTIVE RESPONSE TO LINACLOTIDE IN PATIENTS WITH IRRITABLE BOWEL SYNDROME WITH CONSTIPATION: RESULTS AT WEEK 4 PREDICT SUSTAINED RESPONSE
Results: 96 patients were eligible and treated (ITT analysis) after a 4-week screening period; 60 patients were included in the per protocol (PP) analysis. The majority were female (91; 95%) and mean age was 47 years. Mean baseline IBSSS score was 371 and mean time from diagnosis was 7.5 years (ITT). At Weeks 4 and 12, 23% and 25% of patients (ITT), and 32% and 37% of patients (PP), respectively, had a clinical response based on subjective improvement and IBSSS score. At Weeks 4 and 12, 64% and 55% of patients had subjective responses, and 24% and 32% had IBSSS score responses, respectively (ITT). If one of both criteria were considered, 61.5% (ITT) and 80% (PP) of patients obtained some benefit at Week 12. Baseline variables were not associated with response at Week 12, but response at Week 4 was independently associated with Week 12 response (OR: 6.5 [95% CI: 2.1, 19.8]). Digestive non-intestinal and extra-digestive symptom scores were significantly improved by Weeks 4 and 12 (Table). The most common adverse event was diarrhea (n=39; 21%). No serious adverse events occurred.
Table. Digestive non-intestinal and extra-digestive symptom scores (ITT population)
Includes reflux and dyspepsia; bIncludes back pain, headaches, chest pain, dizziness, fainting spells, feeling heart pound or race, shortness of breath, pain or problems during sexual intercourse, pain in arms, legs, or joints, feeling tired or having low energy, menstrual cramps or other problems with periods (women only), and trouble sleeping *p=0.001 vs. baseline; **p<0.001 vs. baseline SD, standard deviation
Conclusions: Linaclotide relieves intestinal, non-intestinal, and extra-digestive symptoms in patients with clinically relevant IBS-C. Baseline characteristics were not predictive of response at Week 12, but response at Week 4 was independently associated with a sustained response at Week 12.