ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 0424

The Efficacy and Safety of CT-P13 as First-line and Subsequent-line Therapy in Patients with Ankylosing Spondylitis: Real-life Data from TURKBIO Cohort

Sadettin Uslu1, Semih Gulle1, Gercek Can2, Soner Senel3, Sedat Capar4, Huseyin ediz dalkilic5, Servet Akar6, Suleyman Serdar Koca7, Abdurrahman Tufan8, Ayten Yazici9, Sema Yilmaz10, Nevsun Inanc11, Merih Birlik1, Dilek Solmaz12, Ayse Cefle9, Berna Goker13, Servet Yolbas14, Niels Steen Krough15, Neslihan Yilmaz16, Sukran Erten17, Cemal Bes18, Ozgul Soysal19, Mehmet Akif Ozturk13, Seminur Haznedaroglu13, Sule Yavuz16, Haner Direskeneli20, Fatoş Onen21 and Ismail Sari22, 1Dokuz Eylul University School of Medicine Division of Rheumatology, Izmir, Turkey, 2Dokuz Eylul University School of Medicine Division of Rheumatology, Istanbul, Turkey, 3Erciyes University School of Medicine Division of Rheumatology, Kayseri, Turkey, 4Dokuz Eylul University Faculty of Science Department of Statistics, Izmir, Turkey, 5Uludag University School of Medicine Division of Rheumatology, Bursa, Turkey, 6Izmir Katip Celebi University School of Medicine, Izmir, Turkey, 7Firat University School of Medicine Division of Rheumatology, Elazıg, Turkey, 8Gazi University Medical Faculty Hospital, Istanbul, Turkey, 9Kocaeli University School of Medicine Division of Rheumatology, Kocaeli, Turkey, 10Selcuk University School of Medicine Division of Rheumatology, Konya, Turkey, 11Marmara University School of Medicine, Division of Rheumatology, Istanbul, Turkey, 12Kâtip Celebi University School of Medicine Division of Rheumatology, Izmir, Turkey, 13Gazi University School of Medicine Division of Rheumatology, Ankara, Turkey, 14Inonu University School of Medicine Division of Rheumatology, Malatya, Turkey, 15Zitelab Aps, Kopenhag, Denmark, 16Demiroglu Bilim University School of Medicine Division of Rheumatology, Istanbul, Turkey, 17Yildirim Beyazit University School of Medicine Division of Rheumatology, Ankara, Turkey, 18Basaksehir Cam and Sakura ospital, Division of Rheumatology, Istanbul, Turkey, 19Celal Bayar University, School of Medicine Division of Rheumatology, Manisa, Turkey, 20Marmara University School of Medicine Division of Rheumatology, Istanbul, Turkey, 21Dokuz Eylul University, Faculty of Medicine, Rheumatology, İzmir, Turkey, 22Dokuz Eylul University School of Medicine Division of Rheumatology, İzmir, Turkey

Meeting: ACR Convergence 2022

Keywords: , , ,

Session Information

Date: Saturday, November 12, 2022

Title: Spondyloarthritis Including PsA – Treatment Poster I: AxSpA

Session Type: Poster Session A

Session Time: 1:00PM-3:00PM

Background/Purpose: In this study, it was aimed to evaluate the long-term drug survival, efficacy and safety of infliximab biosimilar CT-P13 in Turkish patients diagnosed with ankylosing spondylitis (AS) in clinical practice. The primary outcome is the assessment of drug retention (ie, time until treatment discontinuation or switching to another biological therapy) and disease activity scores in Turkish patients with AS. Additional results evaluated its efficacy and safety.

Methods: Data were collected from TURKBIO database. CT-P13 efficacy was assessed using standard disease activity parameters, while drug-related serious adverse events (AEs) were recorded.

Results: Between December 2014 and December 2021, 179 patients with AS treated with CT-P13 were enrolled. Of these, 123 (68.7%) were using CT-P13 as first-line therapy. The mean duration of treatment was 3.5 years (Table 1). After 3 years of follow-up, CT-P13 drug survival rates in the general patient population were 58.6% and 48.2% in naive and ≥1 TNFi switch patients, respectively (Table 2 and Graphic 1). While the most common reason for treatment changes was treatment failure, AEs were the other most common reason for discontinuation of treatment. Disease activity decreased significantly compared to baseline after initiation of CT-P13 therapy and remained stable for a long time. In a follow-up of more than 5 years, treatment change was required due to severe allergic reaction in 4 patients (2.2%) and moderate allergic reaction in 5 patients (2.7%). During the treatment, TNFi treatment was completely discontinued because cancer developed in 2 (1.1%) patients, osteomyelitis in 1 (0.5%) and drug-related lupus in 1 (0.5%) (Table 2).

Conclusion: In this real-life data study, CT-P13 therapy achieved promising drug-survival rates with reasonable long-term efficacy and safety in naïve and ≥1 TNFi-refractory Turkish AS patients.

Supporting image 1

Table 1

Supporting image 2

Table 2

Supporting image 3

Graphic 1

Disclosures: S. Uslu, None; S. Gulle, None; G. Can, None; S. Senel, None; S. Capar, None; H. dalkilic, None; S. Akar, AbbVie, Lilly, MSD, Novartis, Pfizer, UCB; S. Koca, None; A. Tufan, None; A. Yazici, None; S. Yilmaz, None; N. Inanc, AbbVie/Abbott, Eli Lilly, Merck/MSD, novartis, Pfizer, Roche, Amgen, Celltrion, UCB; M. Birlik, None; D. Solmaz, None; A. Cefle, None; B. Goker, None; S. Yolbas, None; N. Krough, None; N. Yilmaz, None; S. Erten, None; C. Bes, None; O. Soysal, None; M. Ozturk, None; S. Haznedaroglu, None; S. Yavuz, None; H. Direskeneli, None; F. Onen, None; I. Sari, None.

To cite this abstract in AMA style:

Uslu S, Gulle S, Can G, Senel S, Capar S, dalkilic H, Akar S, Koca S, Tufan A, Yazici A, Yilmaz S, Inanc N, Birlik M, Solmaz D, Cefle A, Goker B, Yolbas S, Krough N, Yilmaz N, Erten S, Bes C, Soysal O, Ozturk M, Haznedaroglu S, Yavuz S, Direskeneli H, Onen F, Sari I. The Efficacy and Safety of CT-P13 as First-line and Subsequent-line Therapy in Patients with Ankylosing Spondylitis: Real-life Data from TURKBIO Cohort [abstract]. Arthritis Rheumatol. 2022; 74 (suppl 9). https://acrabstracts.org/abstract/the-efficacy-and-safety-of-ct-p13-as-first-line-and-subsequent-line-therapy-in-patients-with-ankylosing-spondylitis-real-life-data-from-turkbio-cohort/. Accessed .

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/the-efficacy-and-safety-of-ct-p13-as-first-line-and-subsequent-line-therapy-in-patients-with-ankylosing-spondylitis-real-life-data-from-turkbio-cohort/