Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study.
OBJECTIVE
To investigate the efficacy and safety of switching from infliximab reference product (RP) to its biosimilar or maintaining biosimilar treatment in patients with ankylosing spondylitis (AS).


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.


BACKGROUND
NCT01571206; Results.
IN-HA University, School of Medicine, Medicine/Rheumatology, Incheon, Republic of Korea.
Won
W
Park
Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea.
Dae Hyun
DH
Yoo
Universidad de Chile and Centro de Estudios Reumatologicos, Santiago de Chile, Chile.
Pedro
P
Miranda
Department of Rheumatology and Internal Diseases, Pomeranian Medical University in Szczecin, Szczecin, Poland.
Marek
M
Brzosko
Medical University of Wroclaw, Wroclaw, Poland.
Piotr
P
Wiland
Department of Rheumatology, Hospital Civil de Guadalajara "Fray Antonio Alcalde" CUCS, Universidad de Guadalajara, Guadalajara Jalisco, Mexico.
Sergio
S
Gutierrez-Ureña
Outpatient Clinic 'ORTO', Riga, Latvia.
Helena
H
Mikazane
Division of Rheumatology, Department of Internal Medicine, School of Medicine, Kyung Hee University, Seoul, Republic of Korea.
Yeon-Ah
YA
Lee
I.Ya. Horbachevsky Ternopil State Medical University, Municipal Institution of Ternopil Regional Council "Ternopil University Hospital", Ternopil, Ukraine.
Svitlana
S
Smiyan
IN-HA University, School of Medicine, Medicine/Rheumatology, Incheon, Republic of Korea.
Mie-Jin
MJ
Lim
Multiprofile Hospital for Active Treatment 'Sv. Marina', Varna, Bulgaria.
Vladimir
V
Kadinov
Hospital Central and Faculty of Medicine, Universidad Autónoma de San Luis Potosi, San Luis Potosi, Mexico.
Carlos
C
Abud-Mendoza
CELLTRION, Incheon, Republic of Korea.
HoUng
H
Kim
CELLTRION, Incheon, Republic of Korea.
Sang Joon
SJ
Lee
CELLTRION, Incheon, Republic of Korea.
YunJu
Y
Bae
CELLTRION, Incheon, Republic of Korea.
SuYeon
S
Kim
Rheumazentrum Ruhrgebiet, Herne, Germany.
Jürgen
J
Braun
D000293:Adolescent; D000328:Adult; D000368:Aged; D000906:Antibodies / Q000276:immunology; D000911:Antibodies, Monoclonal / Q000276:immunology / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000276:immunology / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals; D004351:Drug Resistance / Q000276:immunology; D057915:Drug Substitution; D005260:Female; D006801:Humans; D000069285:Infliximab / Q000276:immunology / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D013167:Spondylitis, Ankylosing / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
D000906:Antibodies; D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D059451:Biosimilar Pharmaceuticals; C000591237:CT-P13; D000069285:Infliximab
Ankylosing Spondylitis; Anti-TNF; DMARDs (biologic); Treatment