Article Text

Download PDFPDF
PTU-186 Baseline characteristics as a predictor of response to linaclotide (constella®) in patients with irritable bowel syndrome with constipation: a pooled analysis of 2 phase 3 trials
  1. C Díaz1,
  2. M Falques1,
  3. D Vilardell1,
  4. J Fortea1,
  5. JM Johnston2
  1. 1Almirall S. A., Barcelona, Spain
  2. 2Ironwood Pharmaceuticals, Cambridge, USA


Introduction In 2 Phase 3 trials in irritable bowel syndrome with constipation (IBS-C) (Trial 31, Trial 302), linaclotide 290 μg once-daily (Constella®; LIN) treatment was superior to placebo (PBO) based on European Medicines Agency co-primary endpoints (rate of abdominal pain/discomfort responders [Trial 31: 54.8% vs 41.8%; Trial 302: 54.1% vs 38.5%; P < 0.001]; IBS degree-of-relief responders [Trial 31: 37.0% vs 18.5%; Trial 302: 39.4% vs 16.6%; P < 0.0001]). A potential association between baseline patient characteristics and likelihood of therapeutic response to LIN is unclear.

Method This pooled analysis evaluated potential predictive value of baseline characteristics in 2 pivotal Phase 3 trials in IBS-C by comparing demographics and baseline symptoms (Table) for LIN 12-week non-responders vs responders, defined as: 1) abdominal pain/discomfort responders (≥30% reduction in abdominal pain and/or discomfort score [11-point scales], with neither worsening from baseline, for ≥6/12 weeks) and 2) IBS degree-of-relief responders (symptoms ‘considerably’ or ‘completely’ relieved for ≥6/12 weeks).

Abstract PTU-186 Table 1

Pooled responder rates stratified by baseline characteristics

Results The pooled analysis included 1602 patients (LIN, n = 805; PBO, n = 797). Baseline characteristics were similar for responders and non-responders in the LIN and PBO groups for both endpoints (Table 1). Abdominal discomfort scores and body mass index were also similar for responders and non-responders (not shown).

Conclusion The baseline demographics and disease characteristics analysed did not predict treatment response to LIN or PBO in patients with IBS-C in the Phase 3 pivotal trials.

Disclosure of interest C. Díaz Employee of: Almirall S. A., M. Falques Employee of: Almirall S. A., D. Vilardell Employee of: Almirall S. A., J. Fortea Employee of: Almirall S. A., J. Johnston Employee of: Ironwood Pharmaceuticals.

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.