Date: Sunday, November 7, 2021
Session Title: Epidemiology & Public Health Poster II: Inflammatory Arthritis – RA, SpA, & Gout (0560–0593)
Session Type: Poster Session B
Session Time: 8:30AM-10:30AM
Background/Purpose: In routine care, biosimilar to biosimilar infliximab switching may occur to save costs (=non-medical switching). Previous studies have investigated the efficacy and safety of a switch from originator infliximab to one of its biosimilars, whereas evidence regarding biosimilar to biosimilar switching is non-existing. Thus, robust, well-designed studies are needed to investigate the consequences of multiple switches on treatment effectiveness, drug safety and patient-reported outcomes.
In this real-life study, we aimed to explore baseline clinical characteristics and one-year treatment status in patients with inflammatory arthritis, who underwent mandatory multiple infliximab biosimilar switches (from originator infliximab to CT-P13 and subsequently to GP1111).
Methods: Observational cohort study based on DANBIO registry (clinical data) linked with national patient registries (prior comorbidities). For each switch, main outcomes were one-year treatment status (withdrawn yes/no), reasons for withdrawal, and baseline characteristics associated with withdrawal (Mann-Whitney, χ² test).
Results: In 2015, 780 patients switched from originator infliximab to biosimilar CT-P13 in accordance with a national guideline (366 RA/113 PsA/256 AxSpA; 51% women; median age 56 years; disease duration 14 years, infliximab treatment 7 years), Table. At baseline, 42% was in remission. At 1 year, 83% maintained CT-P13 treatment.
In 2019, 52% of the 780 patients were still receiving treatment with CT-P13 and performed a 2nd biosimilar switch to GP1111 due to change of guideline. After 1 year, 91% maintained GP1111, Figure.
For both rounds of switching, withdrawal during follow-up was associated with higher baseline patient-reported outcomes (PROs), higher HAQ and less frequent acceptable symptom state (PASS=yes) whereas objective markers (CRP, physician global) were similar.
Conclusion: Multiple biosimilar infliximab switches were well tolerated in patients who were long-term users of the originator. Risk of withdrawal was associated with higher baseline PROs, suggesting that outcomes were more affected by patient-related than drug-related factors.
Acknowledgements: We thank departments reporting to the DANBIO registry. Partly sponsored by Sandoz, who had no influence on the analysis, interpretation and presentation of data.
To cite this abstract in AMA style:Nabi H, Glintborg B, Loft A, Hendricks O, Pedersen J, Just S, Ahmed R, Danebod K, Munk H, Colic A, Linauskas A, Jensen D, Raun J, Grydehøj J, Christensen L, Manilo N, Lomborg N, Kristensen S, Mehnert F, Krogh N, Hetland M. Biosimilar to Biosimilar Infliximab Switching in Real-world Patients with Inflammatory Arthritis Followed in the Danish DANBIO Registry: Switch from Originator Infliximab to CT-P13 and Then to GP1111 [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/biosimilar-to-biosimilar-infliximab-switching-in-real-world-patients-with-inflammatory-arthritis-followed-in-the-danish-danbio-registry-switch-from-originator-infliximab-to-ct-p13-and-then-to-gp1111/. Accessed June 6, 2023.
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