New-Onset Inflammatory Bowel Diseases Among IL-17 inhibitors-Treated Patients: Results From The Case-Control MISSIL Study

Author:

Letarouilly Jean-Guillaume1ORCID,Pham Thao2,Pierache Adeline34,Acquacalda Émilie5,Banneville Beatrice6,Barbarot Sébastien7,Baudart Pauline8,Bauer Élodie9,Claudepierre Pascal10,Constantin Arnaud11,Dernis Emmanuelle12,Felten Renaud13,Gaudin Philippe14,Girard Céline15,Gombert Bruno16,Goupille Philippe17,Guennoc Xavier18,Henry-Desailly Isabelle19,Jullien Denis20,Karimova Elena21,Lanot Sylvain22,Le Dantec Loïc23,Pascart Tristan24,Plastaras Laurianne25,Sultan Nathalie26,Truchet Xavier27,Varin Stephane28,Wendling Daniel29,Gaboriau Louise30,Staumont-Sallé Delphine31,Peyrin-Biroulet Laurent32,Flipo Rene-Marc1

Affiliation:

1. Service de rhumatologie, Université de Lille, CHU Lille, Lille, France

2. Service de rhumatologie, Aix Marseille University, APHM, Marseille, France

3. Université de Lille, CHU Lille, ULR 2694—METRICS: évaluation des technologies de santé et des pratiques médicales, Lille, France

4. Département des biostatistiques, CHU de Lille, Lille, France

5. Service de rhumatologie, Princess Grace Hospital Centre, Monaco, Monaco

6. Service de rhumatologie, University Hospital Pitié Salpêtrière, APHP

7. Université de Nantes, CHU Nantes, Service de dermatologie, UMR 1280 PhAN, INRAE, Nantes, France

8. Service de rhumatologie, CHU Caen, Caen, France

9. Service de rhumatologie, CHU de Nancy, Nancy, France

10. Service de rhumatologie, Université Paris Est Créteil Val de Marne, EA 7379—Epiderme, AP-HP, Hôpital Henri-Mondor, Créteil, France

11. Service de rhumatologie, CHU Toulouse, Toulouse, France

12. Service de rhumatologie, CH Le Mans, Le Mans, France

13. CHU de Strasbourg, Service de rhumatologie, Département Universitaire de Pharmacologie, Addictologie, Toxicologie et Thérapeutique, Université de Strasbourg, Strasbourg, France

14. Service de rhumatologie, CHU Grenoble Alpes, Grenoble, France

15. Service de dermatologie, CHU Montpellier, Montpellier, France

16. Service de rhumatologie, CH La Rochelle, La Rochelle, France

17. Service de rhumatologie, CHU de Tours, Tours, France

18. Service de rhumatologie, Centre Hospitalier de Saint-Brieuc, Saint-Brieuc, France

19. Service de rhumatologie, Centre Hospitalier Universitaire Amiens-Picardie, Amiens, France

20. CHU Lyon, Service de dermatologie, Hôpital Edouard Herriot, Lyon, France

21. Service de dermatologie, CH Lens, Lens, France

22. Service de rhumatologie, Centre Hospitalier Intercommunal Alençon-Mamers, Alençon, France

23. Service de rhumatologie, Polyclinique d’Henin-Beaumont, Hénin-Beaumont, France

24. Service de rhumatologie, GHICL, Hôpital Saint-Philibert, Lomme, France

25. Service de gastroentérologie, CH Colmar, Colmar, France

26. CH Ouest-Réunion, Saint-Paul, La Réunion, France

27. Service de pathologies digestives, HIA Sainte Anne, Toulon, France

28. Service de rhumatologie, CHD Vendée, La Roche-sur-Yon, France

29. CHU Besançon, Service de rhumatologie, EA 4266, Université de Franche-Comté, Besançon, France

30. Centre régional de pharmacovigilance, Service de pharmacologie médicale, CHU de Lille, Lille, France

31. Université de Lille, CHU Lille, Service de dermatologie, U1286 Inserm INFINITE, Lille, France

32. Service de gastroentérologie, CHU de Nancy, Nancy, France

Abstract

Abstract Objectives To describe new-onset inflammatory bowel diseases (new IBD) in patients treated with interleukin 17 inhibitors (IL-17i), to assess their incidence and to identify their risk factors in real life. Methods A French national registry (MISSIL) aimed to report all cases of new IBD in patients treated with IL-17i from January 2016 to December 2019. Using the estimated number of patients treated by IL-17 in France during the study period, the annual incidence rates of new IBD was reported in IL-17i-treated patients. A case–control study was performed with two controls per new IBD case matched by gender, age and underlying inflammatory disease. Results 31 cases of new IBD under IL-17i were collected: 27 patients treated for spondyloarthritis and 4 patients for psoriasis. All were observed with secukinumab (SEK). The median time to onset of new IBD symptoms was 4.0 (1.5–7.5) months. SEK was discontinued in all patients. The evolution was favourable with complete resolution (17/31), improvement (7/31) or stabilization (5/31). 2 patients died: one due to a massive myocardial infarction and one due to post-colectomy complications. The incidence of new IBD decreased from 0.69/100 PY (7/1010) in 2016, to 0.08/100PY (6/7951) in 2019. No previous treatment with etanercept (OR = 0.33, IC95% 0.14–0.80, p= 0.014) and low number of previous biological therapies (OR = 0.67, 95%CI 0.47–0.94, p= 0.021) were significantly associated with new IBD. Conclusion The incidence of new IBD was low and decreased from 2016 to 2019. The outcome was favourable in 24 out of 31 patients, but two patients died.

Publisher

Oxford University Press (OUP)

Subject

Pharmacology (medical),Rheumatology

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