Efficacy and Safety of CT-P13 as First- and Second-Line Treatment in Patients with Ankylosing Spondylitis

<b>Background/Objectives:</b> CT-P13 is a biosimilar version of infliximab, a monoclonal antibody. In individuals with ankylosing spondylitis (AS), CT-P13 has been shown to be effective and to have a well-tolerated safety profile. The aim of this study was to evaluate the long-term drug persistence, safety, and efficacy of infliximab biosimilar CT-P13 in patients with AS undergoing first-line (1st-line) and later (≥2nd-line) treatment in clinical practice. <b>Methods:</b> We performed an observational cohort study that included AS patients based on the biological drug database in the TURKBIO Registry between 2014 and 2021. The patients were divided into two groups: those receiving CT-P13 as first-line treatment or as a switch (≥2nd-line) from another TNF inhibitor (TNFi). Standard disease activity metrics were used to assess the effectiveness of CT-P13, and drug retention rates were investigated. <b>Results:</b> There were 179 AS patients using CT-P13 (47.4% male, mean age: 42.9 ± 11.3 years). Of these patients, 123 (68.7%) were receiving CT-P13 as a first-line treatment. The mean length of treatment was 3.5 years. CT-P13 drug retention rates in the general patient population were 58.6% and 48.2% in the first-line and ≥second-line treatment, respectively, after 3 years of follow-up. The most common reason for CT-P13 treatment discontinuation was lack of efficacy. The first-line CT-P13 group had statistically substantially higher ASAS20/40 response rates at three and six months. Nonetheless, both groups' response rates at one year were comparable. <b>Conclusions:</b> In this real-world data analysis, AS patients who were TNFi naïve (1st-line) and subsequently treated (≥2nd-line) with CT-P13 showed encouraging drug retention rates with acceptable long-term effectiveness and safety.

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Publication Details

Journal
Journal of Clinical Medicine
Published
2024-11-29
DOI
https://doi.org/10.3390/jcm13237266
Citations
2
Primary Topic
Biosimilars and Bioanalytical Methods
Type
article
Field-Weighted Citation Impact
0.48
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article

Efficacy and Safety of CT-P13 as First- and Second-Line Treatment in Patients with Ankylosing Spondylitis

Ediz Dalkılıç, Servet Akar, Niels Steen Krogh, Berna Göker et al.
2 citations
Journal of Clinical Medicine
Biosimilars and Bioanalytical Methods
0.48
article

Efficacy and Safety of CT-P13 as First- and Second-Line Treatment in Patients with Ankylosing Spondylitis

Ediz Dalkılıç, Servet Akar, Niels Steen Krogh, Berna Göker, Semih Gülle, Ayşe Çefle, Ayten Yazıcı, Abdurrahman Tufan, Sedat Çapar, Şeminur Haznedaroğlu, Merih Bırlık, Cemal Beş, Özgül Soysal Gündüz, Şule Yavuz, Sadettin Uslu, Servet Yolbaş, Şükran Erten, Sema Dereli Yılmaz, Süleyman Serdar Koca, Fatoş Önen, İ̇smail Sarı, Neslihan Yılmaz, Dilek Solmaz, Mehmet Akif Öztürk, Haner Direskeneli, Soner Şenel, Nevsun İnanç, Gerçek Şen
article en
2 citations

Abstract

<b>Background/Objectives:</b> CT-P13 is a biosimilar version of infliximab, a monoclonal antibody. In individuals with ankylosing spondylitis (AS), CT-P13 has been shown to be effective and to have a well-tolerated safety profile. The aim of this study was to evaluate the long-term drug persistence, safety, and efficacy of infliximab biosimilar CT-P13 in patients with AS undergoing first-line (1st-line) and later (≥2nd-line) treatment in clinical practice. <b>Methods:</b> We performed an observational cohort study that included AS patients based on the biological drug database in the TURKBIO Registry between 2014 and 2021. The patients were divided into two groups: those receiving CT-P13 as first-line treatment or as a switch (≥2nd-line) from another TNF inhibitor (TNFi). Standard disease activity metrics were used to assess the effectiveness of CT-P13, and drug retention rates were investigated. <b>Results:</b> There were 179 AS patients using CT-P13 (47.4% male, mean age: 42.9 ± 11.3 years). Of these patients, 123 (68.7%) were receiving CT-P13 as a first-line treatment. The mean length of treatment was 3.5 years. CT-P13 drug retention rates in the general patient population were 58.6% and 48.2% in the first-line and ≥second-line treatment, respectively, after 3 years of follow-up. The most common reason for CT-P13 treatment discontinuation was lack of efficacy. The first-line CT-P13 group had statistically substantially higher ASAS20/40 response rates at three and six months. Nonetheless, both groups' response rates at one year were comparable. <b>Conclusions:</b> In this real-world data analysis, AS patients who were TNFi naïve (1st-line) and subsequently treated (≥2nd-line) with CT-P13 showed encouraging drug retention rates with acceptable long-term effectiveness and safety.

Journal of Clinical MedicineVol. 13(23)
Bursa Uludağ Üni̇versi̇tesi̇ (TR), Selçuk University (TR), Fırat University (TR), Istanbul Bilim University (TR), Manisa Celal Bayar University (TR), Dokuz Eylül University (TR), Inonu University (TR), Izmir Kâtip Çelebi University (TR), Ankara Yıldırım Beyazıt University (TR), Kocaeli Üniversitesi (TR), Marmara University (TR), Erciyes University (TR), Gazi University (TR)
Good health and well-being
Openalex Percentile: Top 33%
Biosimilars and Bioanalytical Methods
0.48
DOIOpen Access PDFOpenAlex
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