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Abstract Number: 0573

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

Hafsah Nabi1, Bente Glintborg2, Anne Gitte Loft3, Oliver Hendricks4, Jens Kristian Pedersen5, Søren Andreas Just6, Rabiah Ahmed7, Kamilla Danebod7, Heidi Munk8, Ada Colic9, Asta Linauskas10, Dorte Vendelbo Jensen11, Johnny Raun12, Jolanta Grydehøj13, Louise Brot Christensen14, Natalia Manilo15, Niels Lomborg16, Salome Kristensen17, Frank Mehnert18, Niels Steen Krogh19 and Merete Hetland20, 1DANBIO and Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics, Rigshospitalet, Copenhagen, Denmark, 2COPECARE, Centre for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark, Glostrup, Denmark, 3Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark, 4Danish Hospital for Rheumatic Diseases, University Hospital of Southern Denmark, Snderborg, Denmark, 5Section of Rheumatology, Department of Medicine, Svendborg Hospital – Odense University Hospital, Svendborg, Denmark, 6Section of Rheumatology, Dept. of Medicine, Svendborg Hospital, Svendborg, Denmark, 7Department of Rheumatology, Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics, Rigshospitalet, Copenhagen University Hospital, Glostrup, Copenhagen, Denmark, 8Department of Rheumatology, Odense University Hospital, Odense, Denmark, 9Department of Rheumatology, Zealand University Hospital, Køge, Denmark, 10Department of Rheumatology, North Denmark Regional Hospital, Hjoerring, Denmark, 11Department of Internal Medicine, Rønne Hospital, Rønne, Denmark, 12Department of Rheumatology, Sygehus Lillebælt, Fredericia, Denmark, 13Department of Rheumatology, Holstebro Hospital, Holstebro, Denmark, 14Department of Rheumatology, Gentofte and Herlev Hospital, Copenhagen University Hospital, Gentofte, Denmark, 15Department of Rheumatology, Frederiksberg Hospital, Frederiksberg, Denmark, 16Department of Rheumatology, Vejle Hospital Lillebælt, Vejle, Odense C, Denmark, 17Department of Rheumatology, Aalborg University Hospital, Aalborg, Denmark, 18Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark, 19ZiteLab ApS, Copenhagen, Denmark, Frederiksberg, Denmark, 20DANBIO and COPECARE, Centre for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark

Meeting: ACR Convergence 2021

Keywords: Ankylosing spondylitis (AS), Biologicals, Disease-Modifying Antirheumatic Drugs (Dmards), Pharmacoepidemiology, rheumatoid arthritis

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Session Information

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.


Disclosures: H. Nabi, None; B. Glintborg, BMS, 5, Pfizer, 5, Sandoz, 5; A. Loft, AbbVie, 2, 12, Paid Instructor, Eli Lilly Denmark A/S, 2, 12, Paid Instructor, Janssen-Cilag A/S, 2, 12, Paid Instructor, MSD, 2, 12, Paid Instructor, Novartis, 2, 5, 12, Paid Instructor, Pfizer, 2, 12, Novartis, UCB, 2, 12, Paid Instructor; O. Hendricks, Pfizer, 6, AbbVie, 6, Novartis, 6; J. Pedersen, None; S. Just, None; R. Ahmed, None; K. Danebod, None; H. Munk, None; A. Colic, None; A. Linauskas, None; D. Jensen, None; J. Raun, None; J. Grydehøj, None; L. Christensen, None; N. Manilo, None; N. Lomborg, None; S. Kristensen, None; F. Mehnert, None; N. Krogh, None; M. Hetland, Biogen, 2, 5, 6, Celltrion, 2, 6, Janssen Biologics B.V, 2, 6, MSD, 2, 6, Pfizer, 2, 5, 6, Samsung Bioepis, 2, 6, AbbVie, 5, BMS, 5, Eli Lilly Denmark A/S, 5, 12, personal fees, Lundbeck Fond, 5, Roche, 5, Sandoz, 5, Novartis, 5, Merck, 5, Orion Pharma, 12, personal fees, Medac, 6.

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 January 27, 2023.
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