PMID- 29045077
OWN - NLM
STAT- MEDLINE
DCOM- 20190111
LR  - 20220330
IS  - 2326-5205 (Electronic)
IS  - 2326-5191 (Linking)
VI  - 70
IP  - 1
DP  - 2018 Jan
TI  - Subjective Complaints as the Main Reason for Biosimilar Discontinuation After 
      Open-Label Transition From Reference Infliximab to Biosimilar Infliximab.
PG  - 60-68
LID - 10.1002/art.40324 [doi]
AB  - OBJECTIVE: To evaluate drug survival, effectiveness, pharmacokinetics, 
      immunogenicity, and safety in daily practice after transitioning treatment from 
      original reference infliximab (Remicade [REM]) to a biosimilar infliximab (CT-P13 
      [Remsima; Inflectra]) in patients with rheumatoid arthritis, psoriatic arthritis, 
      or ankylosing spondylitis. METHODS: Of the initial 222 REM-treated patients, 192 
      agreed to transition to CT-P13 and were included in this multicenter prospective 
      cohort study. Changes in the Disease Activity Score in 28 joints using the 
      C-reactive protein level (DAS28-CRP) and the Bath Ankylosing Spondylitis Disease 
      Activity Index (BASDAI) and changes in the CRP levels, infliximab trough levels, 
      and anti-infliximab antibody levels were assessed after 6 months, and adverse 
      events (AEs) were documented. Drug survival and prognostic factors were analyzed 
      using Kaplan-Meier and Cox regression analyses. RESULTS: During 6 months 
      follow-up, 24% of the patients (n = 47) discontinued CT-P13. Thirty-seven 
      patients restarted REM, 7 switched to another biologic drug, and 3 continued 
      without a biologic drug. The DAS28-CRP remained stable from baseline to month 6, 
      with a mean +/- SD score of 2.2 +/- 0.9 at baseline to 2.2 +/- 0.8 at 6 months 
      (difference of 0.0 [95% confidence interval (95% CI) -0.1, 0.2]). The BASDAI 
      increased from a mean +/- SD of 3.8 +/- 2.0 at baseline to 4.3 +/- 2.1 at 6 months 
      (difference of +0.5 [95% CI 0.1, 0.9]). The CRP levels, infliximab trough levels, 
      and anti-infliximab antibody levels did not change. Just prior to CT-P13 
      discontinuation, the DAS28-CRP components tender joint count and patient's global 
      assessment of disease activity, as well as the BASDAI were increased compared to 
      baseline. The most frequently reported AEs were arthralgia, fatigue, pruritus, 
      and myalgia. A shorter REM infusion interval (hazard ratio: 0.77 [95% CI 0.62, 
      0.95]) at baseline was predictive of discontinuing CT-P13. CONCLUSION: In our 
      cohort, one-fourth of patients discontinued CT-P13 during 6 months of follow-up, 
      mainly due to an increase in the subjective features of the tender joint count 
      and the patient's global assessment of disease activity and/or subjective AEs, 
      possibly explained by nocebo effects and/or incorrect causal attribution effects.
CI  - (c) 2017, American College of Rheumatology.
FAU - Tweehuysen, Lieke
AU  - Tweehuysen L
AD  - Sint Maartenskliniek, Nijmegen, The Netherlands.
FAU - van den Bemt, Bart J F
AU  - van den Bemt BJF
AD  - Sint Maartenskliniek and Radboud University Medical Center, Nijmegen, The 
      Netherlands.
FAU - van Ingen, Iris L
AU  - van Ingen IL
AD  - Radboud University Medical Center, Nijmegen, The Netherlands.
FAU - de Jong, Alphons J L
AU  - de Jong AJL
AD  - Rijnstate, Arnhem, The Netherlands.
FAU - van der Laan, Willemijn H
AU  - van der Laan WH
AD  - Maartenskliniek, Woerden, The Netherlands.
FAU - van den Hoogen, Frank H J
AU  - van den Hoogen FHJ
AD  - Sint Maartenskliniek and Radboud University Medical Center, Nijmegen, The 
      Netherlands.
FAU - den Broeder, Alfons A
AU  - den Broeder AA
AD  - Sint Maartenskliniek and Radboud University Medical Center, Nijmegen, The 
      Netherlands.
LA  - eng
SI  - NTR/NTR5279
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20171207
PL  - United States
TA  - Arthritis Rheumatol
JT  - Arthritis & rheumatology (Hoboken, N.J.)
JID - 101623795
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Biosimilar Pharmaceuticals)
RN  - 0 (CT-P13)
RN  - 9007-41-4 (C-Reactive Protein)
RN  - B72HH48FLU (Infliximab)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antibodies, Monoclonal/*adverse effects/therapeutic use
MH  - Antirheumatic Agents/adverse effects/immunology/*therapeutic use
MH  - Arthritis/*drug therapy
MH  - Biosimilar Pharmaceuticals/*adverse effects/therapeutic use
MH  - C-Reactive Protein
MH  - Cohort Studies
MH  - Drug Substitution/adverse effects
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Infliximab/adverse effects/immunology/*therapeutic use
MH  - Kaplan-Meier Estimate
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Severity of Illness Index
MH  - Treatment Outcome
MH  - Withholding Treatment
EDAT- 2017/10/19 06:00
MHDA- 2019/01/12 06:00
CRDT- 2017/10/19 06:00
PHST- 2017/04/26 00:00 [received]
PHST- 2017/09/11 00:00 [accepted]
PHST- 2017/10/19 06:00 [pubmed]
PHST- 2019/01/12 06:00 [medline]
PHST- 2017/10/19 06:00 [entrez]
AID - 10.1002/art.40324 [doi]
PST - ppublish
SO  - Arthritis Rheumatol. 2018 Jan;70(1):60-68. doi: 10.1002/art.40324. Epub 2017 Dec 
      7.