Safety and effectiveness of intravenous CT-P13 in inflammatory arthritis: post-marketing surveillance study in Thailand
Ajanee Mahakkanukrauh, Sumapa Chaiamnuay, Ajchara Koolvisoot, Tassanee Kitamnuayphong, Siriporn Manavathongchai, Manathip Osiri, Worawit Louthrenoo, Parichat Uea-areewongsa, Keumyoung Ahn, Nahyun Jung, Minkyung Kim, Seulgi Lee, Hanna Kim, Sunghyun Kim- Oncology
- Immunology
- Immunology and Allergy
Background: The infliximab biosimilar CT-P13 was approved in Thailand in 2015. Methods: This open-label, multicenter, post-marketing surveillance study evaluated the safety (events of special interest [ESIs]; primary end point) and effectiveness of 46 weeks of CT-P13 treatment according to routine practice in patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), or psoriatic arthritis (PsA), with 1 year follow-up post-treatment. Results: 30 patients were enrolled (16 RA, 8 AS and 6 PsA). Infections were the most frequently reported study drug-related ESIs (2 RA and 2 AS). One patient with RA and one with PsA experienced infusion-related reactions. No cases of tuberculosis, malignancy (as expected, given 1 year follow-up), or drug-induced liver disease were reported. Disease activity improved across indications. Conclusion: CT-P13 was well tolerated and effective across indications.