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Anrukinzumab, an anti-interleukin 13 monoclonal antibody, in active UC: efficacy and safety from a phase IIa randomised multicentre study
  1. Walter Reinisch1,2,
  2. Julián Panés3,
  3. Sunil Khurana4,
  4. Gabor Toth5,
  5. Fei Hua6,
  6. Gail M Comer6,
  7. Michelle Hinz6,
  8. Karen Page6,
  9. Margot O'Toole6,
  10. Tara McDonnell Moorehead7,
  11. Hua Zhu8,
  12. YanHui Sun8,
  13. Fabio Cataldi6
  1. 1McMaster University, Hamilton, Ontario, Canada
  2. 2Medical University of Vienna, Vienna, Austria
  3. 3Hospital Clinic I Provincial de Barcelona, CIBERehd, IDIBAPS, Barcelona, Spain
  4. 4Premier Medical Group, Fishkill, New York, USA
  5. 5Szent János Hospital, Budapest, Hungary
  6. 6Pfizer Inc, Collegeville, Pennsylvania, USA
  7. 7InVentiv Health Clinical, Burlington, Massachusetts, USA
  8. 8Pfizer CRDC, Shanghai, China
  1. Correspondence to Professor Julián Panés, Department of Gastroenterology, Hospital Clínic de Barcelona, Villarroel 170, Barcelona 08036, Spain; jpanes{at}clinic.cat

Abstract

Objective Interleukin 13 (IL-13) is thought to play a key role as an effector cytokine in UC. Anrukinzumab, a humanised antibody that inhibits human IL-13, was evaluated for the treatment of UC.

Design In a multicentre, randomised, double-blind, placebo-controlled study, patients with active UC (Mayo score ≥4 and <10) were randomised to anrukinzumab 200, 400 or 600 mg or placebo. Patients received five intravenous administrations over 14 weeks. The primary endpoint was fold change from baseline in faecal calprotectin (FC) at Week 14. Secondary endpoints included safety, pharmacokinetics and IL-13 levels.

Results The modified intention-to-treat population included 84 patients (21 patients/arm). Fold change of FC from baseline at Week 14 was not significantly different for any treatment groups compared with the placebo. The study had a high dropout rate, in part, related to lack of efficacy. The exploratory comparisons of each dose were not significantly different from placebo in terms of change from baseline in total Mayo score, clinical response, clinical remission and proportion of subjects with mucosal healing. An increase in serum total IL-13 (free and bound to anrukinzumab) was observed for all anrukinzumab groups but not with placebo. This suggests significant binding of anrukinzumab to IL-13. The safety profile was not different between the anrukinzumab and placebo groups.

Conclusions A statistically significant therapeutic effect of anrukinzumab could not be demonstrated in patients with active UC in spite of binding of anrukinzumab to IL-13.

Trial registration number ClinicalTrials.gov number NCT01284062.

  • ULCERATIVE COLITIS
  • INTERLEUKINS

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