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

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.

Table 1

Table 2

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.