TY - JOUR T1 - Infliximab biosimilar-to-biosimilar switching in patients with inflammatory rheumatic disease: clinical outcomes in real-world patients from the DANBIO registry JF - RMD Open JO - RMD Open DO - 10.1136/rmdopen-2022-002560 VL - 8 IS - 2 SP - e002560 AU - Hafsah Nabi AU - Oliver Hendricks AU - Dorte Vendelbo Jensen AU - Anne Gitte Loft AU - Jens Kristian Pedersen AU - Søren Andreas Just AU - Kamilla Danebod AU - Heidi Lausten Munk AU - Salome Kristensen AU - Natalia Manilo AU - Ada Colic AU - Asta Linauskas AU - Pia Høger Thygesen AU - Louise Brot Christensen AU - Maren Høgberget Kalisz AU - Niels Lomborg AU - Stavros Chrysidis AU - Johnny Lillelund Raun AU - Marlene Andersen AU - Frank Mehnert AU - Niels Steen Krogh AU - Merete Lund Hetland AU - Bente Glintborg Y1 - 2022/11/01 UR - http://rmdopen.bmj.com/content/8/2/e002560.abstract N2 - Objective Successful uptake of biosimilars in rheumatology is limited by lack of real-world evidence regarding effectiveness of biosimilar-to-biosimilar switching. We investigated infliximab biosimilars CT-P13-to-GP1111 switching among patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (AxSpA).Methods Observational cohort study from the DANBIO registry. Patients were classified as originator-naïve or originator-experienced. Retention rates of 1-year GP1111 treatment were explored (Kaplan-Meier). We identified baseline factors (at the time of switch) associated with withdrawal of GP1111 (multivariable Cox-regression analyses with HRs including originator treatment history). Changes in subjective and objective measures of disease activity 4 months before and after the switch were assessed in individual patients.Results Of 1605 patients (685 RA, 314 PsA and 606 AxSpA, median disease duration was 9 years, 37% in Clinical Disease Activity Index/Ankylosing Spondylitis Disease Activity Score remission), 1171 were originator-naïve. Retention rates at 1-year were 83% (95% CI: 81% to 85%) and 92% (95% CI: 90% to 95%) for the originator-naïve and originator-experienced, respectively. GP1111 retention rates were higher in originator-experienced compared to originator-naïve with RA (HR=0.4 (95% CI: 0.2 to 0.7)) and PsA (HR=0.2 (95% CI: 0.1 to 0.8)), but not significantly for AxSpA: HR=0.6 (95% CI: 0.3 to 1.2). Lower disease activity was associated with higher retention. Changes in disease activity preswitch and postswitch were close to zero.Conclusion This real-world observational study of more than 1600 patients with inflammatory arthritis showed high 1-year retention following a nationwide infliximab biosimilar-to-biosimilar switch. Retention was higher in originator-experienced and in patients with low disease activity, suggesting outcomes to be affected by patient-related rather than drug-related factors.Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information. ER -