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

Session Information

Date: Sunday, November 7, 2021

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 2^nd 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 .

ACR Meeting Abstracts - 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/