Abstract | OBJECTIVES: METHODS: This open-label extension study recruited patients with AS who completed a 54-week, randomised controlled study comparing CT-P13 with RP (PLANETAS). CT-P13 (5 mg/kg) was administered intravenously every 8 weeks from week 62 to week 102. Efficacy end points included the proportion of patients achieving Assessment of SpondyloArthritis international Society (ASAS)20. Antidrug antibodies (ADAs) were measured using an electrochemiluminescent method. Data were analysed for patients treated with CT-P13 in the main PLANETAS study and the extension (maintenance group) and those who were switched to CT-P13 during the extension study (switch group). RESULTS: Overall, 174 (82.9%) of 210 patients who completed the first 54 weeks of PLANETAS and agreed to participate in the extension were enrolled. Among these, 88 were maintained on CT-P13 and 86 were switched to CT-P13 from RP. In these maintenance and switch groups, respectively, ASAS20 response rates at week 102 were 80.7% and 76.9%. ASAS40 and ASAS partial remission were also similar between groups. ADA positivity rates were comparable (week 102: 23.3% vs 27.4%). Adverse events led to treatment discontinuation during the extension study in 3 (3.3%) and 4 (4.8%) patients, respectively. CONCLUSIONS: This is the first study to show that switching from RP to its biosimilar CT-P13 is possible without negative effects on safety or efficacy in patients with AS. In the maintenance group, CT-P13 was effective and well tolerated over 2 years of treatment. TRIAL REGISTRATION NUMBER: NCT01571206; Results.
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Authors | Won Park, Dae Hyun Yoo, Pedro Miranda, Marek Brzosko, Piotr Wiland, Sergio Gutierrez-Ureña, Helena Mikazane, Yeon-Ah Lee, Svitlana Smiyan, Mie-Jin Lim, Vladimir Kadinov, Carlos Abud-Mendoza, HoUng Kim, Sang Joon Lee, YunJu Bae, SuYeon Kim, Jürgen Braun |
Journal | Annals of the rheumatic diseases
(Ann Rheum Dis)
Vol. 76
Issue 2
Pg. 346-354
(Feb 2017)
ISSN: 1468-2060 [Electronic] England |
PMID | 27117698
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
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Copyright | Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/. |
Chemical References |
- Antibodies
- Antibodies, Monoclonal
- Antirheumatic Agents
- Biosimilar Pharmaceuticals
- CT-P13
- Infliximab
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Topics |
- Adolescent
- Adult
- Aged
- Antibodies
(immunology)
- Antibodies, Monoclonal
(immunology, therapeutic use)
- Antirheumatic Agents
(immunology, therapeutic use)
- Biosimilar Pharmaceuticals
- Drug Resistance
(immunology)
- Drug Substitution
- Female
- Humans
- Infliximab
(immunology, therapeutic use)
- Male
- Middle Aged
- Spondylitis, Ankylosing
(drug therapy)
- Treatment Outcome
- Young Adult
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