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Abstract Number: 0936

Factors Associated with the Development of Anti-drug Antibodies to Tumour Necrosis Factor Inhibitors in Patients with Axial Spondyloarthritis; A Two Year Follow-up Study

Elif Ediboglu1, Dilek Solmaz2, Gokhan Kabadayi3, Mustafa Ozmen4, Kübra Kaya5, Muhammet Çınar6, Gökhan Sargın7, Gülen Hatemi8, Ömer Karadağ9, Gülay Kınıklı10, Onay Gercik11, Umut Kalyoncu9, Sedat Yılmaz6, Taskın Şentürk7, Gokhan Keser12, Figen Yargucu12, Ayse Cefle13, Didem Kozacı5, Bünyamin Kısacık14 and Servet Akar2, 1Izmir Katip Celebi University, Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology, İzmir, Turkey, 2Izmir Katip Celebi University, Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology, Izmir, Turkey, 3Cigli Education and Research Hospital, İzmir, Turkey, 4katip çelebi university, izmir, Turkey, 5Yıldırım Beyazit University, Ankara, Turkey, 6Gülhane Education and Research Hospital, Ankara, Turkey, 7Adnan Menderes University, Aydın, Turkey, 8Istanbul University‒Cerrahpaşa, Cerrahpaşa Medical School and Behçet’s Disease Research Center, İstanbul, Turkey, 9Hacettepe University, Ankara, Turkey, 10Ankara University, Ankara, Turkey, 11Izmir Katip Celebi University, Izmir, Turkey, 12Ege University, İzmir, Turkey, 13Kocaeli University, Kocaeli, Turkey, 14Gaziantep Medicalpark Hospital, Gaziantep, Turkey

Meeting: ACR Convergence 2021

Keywords: Anti-TNF Drugs, Autoantibody(ies), spondyloarthritis

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Session Information

Date: Sunday, November 7, 2021

Title: Spondyloarthritis Including PsA – Treatment Poster I: Axial Spondyloarthritis (0908–0939)

Session Type: Poster Session B

Session Time: 8:30AM-10:30AM

Background/Purpose: Axial spondyloarthritis (axSpA) is a chronic inflammatory rheumatic disease affecting sacroiliac joints and spine as well as peripheral joints and entheses. Tumour necrosis factor inhibitors (TNFi) are widely used in patients with persistently high disease activity despite non-steroidal anti-inflammatory drugs. Some patients fail to respond or loose responsiveness during therapy with TNFi. The development of anti-drug antibodies (ADA) might play a role in non-response or some adverse events. However it has never been evaluated for 2-years period.

Objectives: Therefore, the aim of the present study was to evaluate the development of ADA against TNFi longitudinally during 2-years period in axSpA patients and factors associated with it.

Methods: In total 180 axSpA patients according to ASAS classification criteria with a new TNFi prescription in the last two weeks period were included in this observational study. Clinical data and serum samples were collected at baseline and at every 12 weeks. Serum drug levels and ADAs were measured on 12, 24, 52 and 104 weeks of treatment by ELISA in one center to avoid inter-assay variability. The development of ADA over time was investigated by using generalized estimating equations (GEE) which is a technique for longitudinal data analysis allowing the use of all available data even deviated from normality.

Results: 180 biologic naive axSpA patients (116 male, median [IQR] 44,5 [14,5] years) who started anti-TNF agents (infliximab [20%], adalimumab [27,2%], etanercept [32,2%] and golimumab [20,6%]) were included in the analysis (Table 1). In comparison to baseline values BASDAI, ASDAS-CRP and CRP values were significantly decreased in third months of follow-up (Figure 1). In total 172 patients had at 12 weeks, 154 at 24, 121 at 52, and 73 at 104 week serum samples available for ADA determination. In longitudinal analysis; baseline age and TNFi type, as well as longitudinal BASDAI, ASDAS, serum CRP levels and the development of adverse events and discontinuation of the drug were found to be associated with the development of ADA. In order to determine independent association/s with the development of ADA two longitudinal multivariable models were run; (a) with ASDAS as an activity measure, (b) with BASDAI and CRP levels and produced that all the variables were independently associated with longitudinally development of anti-drug antibodies (Table 2). Antibodies to adalimumab were related with lower serum drug levels.

Conclusion: The results of the present study with up to 2 years of follow-up, revealed that the development of ADA against TNFi therapy is associated with high disease activity, the development of adverse events and treatment discontinuation in patients with axSpA. And etanercept might be negatively associated with the development of ADA.


Disclosures: E. Ediboglu, None; D. Solmaz, Roche, 6, Farmanova, 6, Pfizer, 6, Lilly, 6; G. Kabadayi, None; M. Ozmen, None; K. Kaya, None; M. Çınar, None; G. Sargın, None; G. Hatemi, Celgene, 5, AbbVie, 6, Novartis, 6, UCB, 6; . Karadağ, None; G. Kınıklı, None; O. Gercik, None; U. Kalyoncu, None; S. Yılmaz, None; T. Şentürk, None; G. Keser, None; F. Yargucu, None; A. Cefle, None; D. Kozacı, None; B. Kısacık, None; S. Akar, AbbVie, 2, 5, 6, Lilly, 2, 5, 6, MSD, 2, 5, 6, Novartis, 2, 5, 6, Pfizer, 2, 5, 6, Roche, 2, 5, 6, Janssen, 2, 5, 6, UCB, 2, 5, 6, Amgen, 2, 5, 6, Gilead, 2, 5, 6, Abdi Ibrahim, 2, 5, 6, Ilko, 2, 5, 6.

To cite this abstract in AMA style:

Ediboglu E, Solmaz D, Kabadayi G, Ozmen M, Kaya K, Çınar M, Sargın G, Hatemi G, Karadağ , Kınıklı G, Gercik O, Kalyoncu U, Yılmaz S, Şentürk T, Keser G, Yargucu F, Cefle A, Kozacı D, Kısacık B, Akar S. Factors Associated with the Development of Anti-drug Antibodies to Tumour Necrosis Factor Inhibitors in Patients with Axial Spondyloarthritis; A Two Year Follow-up Study [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/factors-associated-with-the-development-of-anti-drug-antibodies-to-tumour-necrosis-factor-inhibitors-in-patients-with-axial-spondyloarthritis-a-two-year-follow-up-study/. Accessed .
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