Outcome of continued infliximab therapy in Crohn’s disease patients with response but without remission after one year of infliximab – a retrospective cohort study

Abstract

Background: Optimal management of Crohn’s disease patients having responded to infliximab but without achieving remission is not well defined. The present study examined if these patients benefit from continued long-term infliximab maintenance therapy.

Method: Retrospective cohort study including all patients treated with infliximab for 1 year until the end of 2017 who have had a response but not reached remission on infliximab. Clinical outcomes were defined by the physicians’ global evaluation, supported by clinical indices and objective markers of disease activity.

Results: In total, 376 Crohn’s disease patients received infliximab. Among these, 76 (20%) were classified as having response but non-remission (RNR) after 1 year of therapy. A great majority (n = 54; 71%) experienced no additional therapeutic benefit after a further year of infliximab maintenance therapy, thus still having RNR. Nineteen patients (25%) obtained remission during continued infliximab, whereas only 4% (n = 3) experienced treatment failure. Although infliximab therapy beyond 2 years (follow-up median 35 months, IQR: 23–55) was accompanied by a higher proportion attaining remission (40%), nearly half (46%) still failed to improve. Among patients who had discontinued infliximab while having RNR (n = 21), half (n = 11) experienced disease flare within five months (median 22 weeks, IQR: 12–31).

Conclusion: Most patients (71%) had no additional therapeutic benefit after an additional year of infliximab therapy, and after a median maintenance infliximab treatment period of 3 years, half still failed to improve further. Considering the importance of achieving complete remission, these patients appear to have an unmet medical need.

Keywords:

• Crohn’s disease
• infliximab
• disease outcome
• prognosis
• patient outcomes

Acknowledgments

This study was supported by a grant from Takeda pharmaceuticals, Denmark. The authors would like to thank Tobias WirenfeldtKlausen, Department of Hematology, Herlev and Gentofte Hospital, Denmark, for statistical support. Further, they also would like to thank Nils Bolstad and David J Warren, Department of Medical Biochemistry, Oslo University Hospital, Oslo, Norway, for measurement of infliximab concentrations.

Disclosure statement

This study was in part supported by a grant from Takeda. S. Buhl has served as speaker for Janssen and as a consultant for Takeda. J. Brynskov has served as advisory board member for Abbvie, MSD, Takeda and Janssen; and as Primary investigator for Abbvie, Quintiles and Janssen. C Steenholdt, M. Borghede, M. Rasmussen, and M.A. Ainsworth have no interests to declare.