PMID- 31365335
OWN - NLM
STAT- MEDLINE
DCOM- 20200403
LR  - 20220609
IS  - 0392-856X (Print)
IS  - 0392-856X (Linking)
VI  - 38
IP  - 2
DP  - 2020 Mar-Apr
TI  - Retention rate and long-term safety of biosimilar CT-P13 in patients with 
      ankylosing spondylitis: data from the Korean College of Rheumatology Biologics 
      registry.
PG  - 267-274
LID - 10.55563/clinexprheumatol/z0va6o [doi]
AB  - OBJECTIVES: To evaluate the long-term drug retention, efficacy, and safety of the 
      infliximab biosimilar CT-P13 in Korean patients with ankylosing spondylitis (AS) 
      in clinical practice. The primary outcome was drug retention (i.e. time to 
      treatment discontinuation or changing to another biologic) in Korean patients 
      with AS. Additional outcomes included efficacy and safety. METHODS: Data were 
      collected through the Korean College of Rheumatology Biologics (KOBIO) registry 
      (ClinicalTrials.gov identifier: NCT01965132). CT-P13 efficacy was assessed using 
      standard disease activity parameters, and safety was evaluated by adverse events 
      (AEs). RESULTS: Between December 2012 and December 2017, 244 patients with AS 
      treated with CT-P13 were enrolled. Of those, 203 (83.2%) received CT-P13 as 
      first-line therapy. The median duration of treatment was 2.05 years. After 4 
      years' follow-up, the retention rate of CT-P13 in the overall patient population 
      was 66%. Treatment changes or discontinuations occurred in 38 (15.6%) and 32 
      (13.1%) patients, respectively. Lack of efficacy was the most common reason for 
      treatment changes, whereas AEs were the most common single cause of 
      discontinuation. Disease activity decreased markedly from baseline following 
      initiation of CT-P13 treatment, and thereafter remained stable. A total of 313 
      AEs occurred in 118 patients (48.4%); the majority (94.6%) were mild or moderate 
      in severity. The most common treatment-related AEs were infusion or 
      injection-site reactions (4.1% of patients), uveitis (3.7%), and skin rash 
      (3.7%). CONCLUSIONS: In this real-world study, CT-P13 demonstrated encouraging 
      drug retention rates and times, together with reasonable long-term efficacy and 
      safety, in Korean patients with AS.
FAU - Kim, Hyoun-Ah
AU  - Kim HA
AD  - Ajou University School of Medicine, Suwon, Republic of Korea.
FAU - Lee, Eunyoung
AU  - Lee E
AD  - Ajou University School of Medicine, Suwon, Republic of Korea.
FAU - Lee, Sun-Kyung
AU  - Lee SK
AD  - Seoul Metropolitan Government-Seoul National University Boramae Medical Center, 
      Seoul, Republic of Korea.
FAU - Park, Yong-Beom
AU  - Park YB
AD  - Yonsei University College of Medicine, Severance Hospital, Seoul, Republic of 
      Korea.
FAU - Lee, Young Nam
AU  - Lee YN
AD  - Celltrion Healthcare Co. Ltd, Incheon, Republic of Korea.
FAU - Kang, Hee Jung
AU  - Kang HJ
AD  - Celltrion Healthcare Co. Ltd, Incheon, Republic of Korea.
FAU - Shin, Kichul
AU  - Shin K
AD  - Seoul Metropolitan Government-Seoul National University Boramae Medical Center, 
      Seoul, Republic of Korea. kideb1@gmail.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT01965132
PT  - Journal Article
DEP - 20190719
PL  - Italy
TA  - Clin Exp Rheumatol
JT  - Clinical and experimental rheumatology
JID - 8308521
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Biosimilar Pharmaceuticals)
RN  - 0 (CT-P13)
RN  - B72HH48FLU (Infliximab)
SB  - IM
MH  - Antibodies, Monoclonal/adverse effects/therapeutic use
MH  - *Antirheumatic Agents/adverse effects/therapeutic use
MH  - *Biosimilar Pharmaceuticals/adverse effects/therapeutic use
MH  - Humans
MH  - *Infliximab/adverse effects/therapeutic use
MH  - Registries
MH  - Republic of Korea
MH  - Rheumatology
MH  - Severity of Illness Index
MH  - *Spondylitis, Ankylosing/drug therapy/immunology
MH  - Treatment Outcome
EDAT- 2019/08/01 06:00
MHDA- 2020/04/04 06:00
CRDT- 2019/08/01 06:00
PHST- 2018/12/17 00:00 [received]
PHST- 2019/05/23 00:00 [accepted]
PHST- 2019/08/01 06:00 [pubmed]
PHST- 2020/04/04 06:00 [medline]
PHST- 2019/08/01 06:00 [entrez]
AID - 13765 [pii]
AID - 10.55563/clinexprheumatol/z0va6o [doi]
PST - ppublish
SO  - Clin Exp Rheumatol. 2020 Mar-Apr;38(2):267-274. doi: 
      10.55563/clinexprheumatol/z0va6o. Epub 2019 Jul 19.