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Re-Routing Infliximab Therapy: Subcutaneous Infliximab Opens a Path Towards Greater Convenience and Clinical Benefit

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Abstract

Subcutaneous infliximab recently received approval for the treatment of various immune-mediated inflammatory diseases in Europe, following pivotal clinical trials in patients with rheumatoid arthritis and inflammatory bowel disease. Subcutaneous infliximab demonstrated an improved pharmacokinetic profile compared with intravenous infliximab: the more stable exposure and increased systemic drug concentrations mean it has been cited as a biobetter. Alongside the pharmacokinetic advantages, potential benefits for efficacy, immunogenicity, and health-related quality-of-life outcomes have been suggested with subcutaneous infliximab. During the coronavirus disease 2019 pandemic, the benefits of subcutaneous over intravenous therapies became apparent: switching from intravenous to subcutaneous infliximab reduced the hospital visit-related healthcare resource burden and potential viral transmission. Clinical advantages observed in pivotal trials are also being seen in the real world. Accumulating experience from four European countries (the UK, Spain, France, and Germany) in patients with rheumatic diseases and inflammatory bowel disease supports clinical trial findings that subcutaneous infliximab is well tolerated, increases serum drug concentrations, and offers maintained or improved efficacy outcomes for patients switching from intravenous infliximab. Initial evidence is emerging with subcutaneous infliximab treatment after intravenous infliximab failure. High patient satisfaction and pharmacoeconomic benefits have also been reported with subcutaneous infliximab. Treatments aligned with patient preferences for the flexibility and convenience of at-home subcutaneous administration could boost adherence and treatment outcomes. Altogether, findings suggest that switching from intravenous to subcutaneous infliximab could be advantageous, and healthcare professionals should be prepared to discuss supporting data as part of shared decision making during patient consultations.

Plain Language Summary

The tumor necrosis factor inhibitor infliximab is one treatment option that may be appropriate for patients with immune-mediated inflammatory diseases. Patients may prefer tumor necrosis factor inhibitors administered via the subcutaneous (SC) or intravenous (IV) route, with preferences influencing treatment satisfaction and outcomes. In 2019, CT-P13 SC became the first SC infliximab product to receive regulatory approval in Europe, based on pivotal clinical studies that compared SC infliximab to IV infliximab in patients with rheumatoid arthritis and inflammatory bowel disease. Subcutaneous infliximab is now approved in Europe for the treatment of adults with rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis. Patients began to switch from IV to SC infliximab outside clinical trials in March 2020, during the coronavirus disease 2019 pandemic. Switching from IV to SC infliximab allowed patients to self-administer treatment at home rather than attend hospital for infusions, reducing potential hospital-acquired infections and lessening the strain on healthcare systems during the pandemic. Clinical trial evidence and growing real-world experience demonstrate that SC infliximab offers clinical advantages in terms of an improved pharmacokinetic profile and potential efficacy, immunogenicity, and health-related quality-of-life benefits compared with IV infliximab. Patients have also reported increased satisfaction with SC infliximab after switching from IV infliximab. Together with the long-standing flexibility and convenience benefits of SC administration, the clinical advantages of SC infliximab make it a valid therapeutic option for rheumatoid arthritis and inflammatory bowel disease. This warrants discussion with appropriate patients as part of shared treatment decision making.

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Acknowledgments

Medical writing support, including the development of a draft outline and subsequent drafts in consultation with the authors, collating author comments, copy editing, fact checking, and referencing, was provided by Beatrice Tyrrell, DPhil, at Aspire Scientific Limited (Bollington, UK). Funding for medical writing support for this article was provided by Celltrion Healthcare Co., Ltd (Incheon, Republic of Korea).

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  1. Rheumatology Research Center, Schlosspark-Klinik Charité, University Medicine Berlin, Berlin, Germany

    Rieke Alten

  2. Celltrion Healthcare Co., Ltd, Incheon, Republic of Korea

    Yoorim An, Dong-Hyeon Kim & SangWook Yoon

  3. Department of Gastroenterology, CHRU-Nancy, University of Lorraine, 5 Rue du Morvan, F-5400, Nancy, France

    Laurent Peyrin-Biroulet

  4. Inserm, NGERE, University of Lorraine, F-5400, Nancy, France

    Laurent Peyrin-Biroulet

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This article was supported by Celltrion Healthcare Co., Ltd (Incheon, Republic of Korea).

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Rieke Alten has received consulting fees or honoraria, and lecture fees from Celltrion. Yoorim An, Dong-Hyeon Kim, and SangWook Yoon are employees of Celltrion Healthcare Co., Ltd. Laurent Peyrin-Biroulet reports grants received from AbbVie, Fresenius Kabi, MSD, and Takeda; consulting fees from AbbVie, Allergan, Alma, Amgen, Applied Molecular Transport, Arena, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Enterome, Enthera, Ferring, Fresenius Kabi, Galapagos, Genentech, Gilead, Hikma, Index Pharmaceuticals, Inotrem, Janssen, Lilly, MSD, Mylan, Nestlé, Norgine, Oppilan Pharma, OSE Immunotherapeutics, Pandion Therapeutics, Pfizer, Pharmacosmos, Roche, Samsung Bioepis, Sandoz, Sterna, Sublimity Therapeutics, Takeda, Theravance, Tillotts, and Vifor; support for travel to study meetings, manuscript preparation, or other purposes from AbbVie, Amgen, Arena, Biogen, Celltrion, Ferring, Galapagos, Gilead, Hikma, Janssen, MSD, Pfizer, Pharmacosmos, Sandoz, Takeda, Tillotts, and Vifor; payment for lectures, including service on speaker bureaus, from AbbVie, Amgen, Arena, Biogen, Celltrion, Ferring, Galapagos, Gilead, Hikma, Janssen, MSD, Pfizer, Pharmacosmos, Sandoz, Takeda, Tillotts, and Vifor; and stock/stock options from CTMA.

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Alten, R., An, Y., Kim, DH. et al. Re-Routing Infliximab Therapy: Subcutaneous Infliximab Opens a Path Towards Greater Convenience and Clinical Benefit. Clin Drug Investig 42, 477–489 (2022). https://doi.org/10.1007/s40261-022-01162-6

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