Introduction
The subcutaneous (SC) formulation of infliximab offers a patient-centered alternative to the intravenous (IV) route, with the potential to improve treatment adherence, quality of life, and reduce the burden of care in patients with inflammatory bowel disease.
Aims & Methods
Aim of our study was to evaluate the clinical impact, safety, and patients’ outcomes associated with the switch from IV to SC infliximab in routine care. This was a single-center observational study incorporating both prospective and retrospective data collection. Patients with confirmed diagnosis of Crohn’s disease (CD) or ulcerative colitis (UC) who received at least two infusions of IV infliximab and subsequently transitioned to SC infliximab 120 mg every other week were eligible for inclusion. The primary endpoint was the impact of switching from IV to SC infliximab on patients' quality of life and work productivity measured through the SF-36 and WPAI-GH questionnaires administered at baseline and at week 52. Secondary endpoints included safety profile and clinical effectiveness, defined as clinical remission or improvement at weeks 8, 24 and 52 following the switch to SC infliximab.
Results
A total of 109 adult patients (72 UC (66,1%), 64 male (58.7%)) were enrolled. Median age was 41.6 ± 12.2 years. The switch from IV to SC infliximab was associated with an improvement in work productivity in both UC and CD at week 52 in terms of absenteeism (p = 0.04; η² = 0.18; 95% CI: 0.03–1.00 in CD and p < 0.001; η² = 0.25 in UC) and productivity loss (p < 0.001; η² = 0.47; 95% CI: 0.34–1.00 in CD and p < 0.001; η² = 0.30 in UC) . No significant differences were found in activity impairment, presenteeism, or across SF-36 domains in either CD or UC cohorts (all p > 0.05). Transitioning from IV to SC infliximab did not affect patients’ perceived quality of life as assessed by physical, mental, or social functioning scores. At week 52, 51 out of 55 (93%) patients with UC and 20 out of 27 (74%) patients with CD were in clinical remission. Switching from IV to SC infliximab was significantly associated with achievement of clinical remission over time in UC (χ² = 8.83, p = 0.03 with Cramér’s V = 0.16). In patients with CD, switching from IV to SC infliximab did not show a statistically significant association with the achievement or maintenance of clinical remission at months 12 (χ² = 1.02, p = 0.80 with Cramér’s V = 0.00; 95% CI: 0.00–0.13). The switch was well tolerated with no new safety issues. In total, 6 patients experienced mild adverse events (erythema in the injection site in 3 patients, urinary tract infection in 1 patient, allergic reaction in 1 patient, and skin rash in 1 patient), leading to treatment discontinuation in 3 cases. No patient suffered from severe adverse events.
Conclusion
Switching from IV to SC infliximab is associated with significant improvements in work productivity at week 52 in both UC and CD. No new safety issues were found. These findings support the SC formulation of infliximab as a safe and effective option in the management of inflammatory bowel disease.
Disclosure
G Fiorino received consultancy fees from Ferring, MSD, AbbVie, Takeda, Janssen, Amgen, Sandoz, Samsung Bioepis, Celltrion. LPeyrin‐Biroulet declares personal fees from Galapagos, AbbVie,Janssen,Genentech,Ferring,Tillots,Celltrion,Takeda,Pfizer, Index Pharmaceuticals, Sandoz, Celgene, Biogen, Samsung Bioepis, Inotrem, Allergan, MSD, Roche, Arena, Gilead, Amgen, BMS,Vifor, Norgine, Mylan, Lilly, Fresenius Kabi, OSE Immunotherapeutics, Enthera, Theravance, PandionTherapeutics,GossamerBio,Viatris, ThermoFisher.Grants fromAbbvie,MSD, Takeda, FreseniusKabi. Stockoptions:CTMA. S Danese has served as a speaker, consultant and advisory board member for Schering‐Plough, AbbVie, MSD, UCB Pharma, Ferring, Cellerix, MilleniumTakeda, Nycomed, Pharma cosmos, Actelion, Alphawasserman, Genentech, Grunenthal, Pfizer, Astra Zeneca, NovoNordisk, Cosmo Pharmaceuticals, Vifor and Johnson&Johnson, NikkisoEuropeGMBH, Theravance
