PMID- 27449503
OWN - NLM
STAT- MEDLINE
DCOM- 20180220
LR  - 20220331
IS  - 1559-0755 (Electronic)
IS  - 0257-277X (Linking)
VI  - 65
IP  - 1
DP  - 2017 Feb
TI  - Safety, efficacy and immunogenicity of switching from innovator to biosimilar 
      infliximab in patients with spondyloarthritis: a 6-month real-life observational 
      study.
PG  - 419-422
LID - 10.1007/s12026-016-8843-5 [doi]
AB  - Biosimilar infliximab (INX) was recently approved by the European Medicine Agency 
      for the treatment of rheumatoid arthritis, ankylosing spondylitis (AS), Crohn's 
      disease, ulcerative colitis, psoriatic arthritis (PsA), and psoriasis on the 
      grounds that its pharmacokinetics, safety, and efficacy were comparable to those 
      of innovator INX. The aim of this study was to investigate the real-life 
      efficacy, safety, and immunogenicity of switching from innovator to biosimilar 
      INX in patients with spondyloarthritis (SpA). Forty-one patients attending three 
      Italian rheumatology centres with a previous diagnosis of SpA and clinically 
      inactive or moderate disease activity (ASDAS-CRP < 2.1; 22 with AS, five with 
      enteropathic arthritis, 10 with PsA, and four with undifferentiated SpA), who had 
      been treated for more than 6 months with innovator INX in accordance with the 
      ASAS/EULAR guidelines, were switched to biosimilar INX for pharmaco-economic 
      reasons (Tuscany Law No. 450 of 7 April 2015) and followed up for 6 months. A 
      record was kept of their BASDAI, BASFI, ASDAS-CRP, DAS28-CRP (in the presence of 
      peripheral disease), MASES, VAS pain scores, the duration of morning stiffness, 
      and adverse events (AEs). At the time of the switch, the patients had a median 
      age of 50.9 years (range 23-80), a median disease duration of 124.5 months (range 
      14-372), and a median duration of treatment with innovator INX of 73.7 months 
      (range 6-144). After 6 months of biosimilar INX therapy, there were no 
      statistical differences in their median BASDAI (2.73 +/- 1.5 vs. 2.6 +/- 1.3, 
      p = .27), BASFI (2.34 +/- 1.3 vs. 2.17 +/- 1.2, p = 0.051), ASDAS-CRP (1.35 +/- 0.3 vs. 
      1.28 +/- 0.2, p = 0.24), DAS28-CRP (2.66 +/- 0.67 vs. 2.67 +/- 0.35, p = 0.92), MASES 
      (0.35 +/- 0.7 vs. 0.17 +/- 0.4, p = 0.08), or VAS pain scores (18 +/- 14.7 vs. 
      16.7 +/- 11.3, p = 0.55), whereas the median duration of morning stiffness had 
      significantly decreased (7.2 +/- 6.9 vs. 5.8 +/- 6, p = 0.02). Furthermore, there was 
      no change in circulating INX (4.22 +/- 2.89 vs 4.84 +/- 2.86 mug/mL, p = 0.80) or 
      anti-INX antibody levels (27.76 +/- 17.13 vs 27.27 +/- 17.28 ng/mL, p = 0.98). The 
      switch from innovator to biosimilar INX in this Italian multicentre SpA cohort 
      was not associated with any statistically significance differences in efficacy, 
      adverse events or anti-drug antibody level.
FAU - Benucci, Maurizio
AU  - Benucci M
AD  - Rheumatology Unit, Azienda Sanitaria di Firenze, S. Giovanni di Dio Hospital, Via 
      Torregalli 3, 50143, Florence, Italy. maubenucci@tiscali.it.
FAU - Gobbi, Francesca Li
AU  - Gobbi FL
AD  - Rheumatology Unit, Azienda Sanitaria di Firenze, S. Giovanni di Dio Hospital, Via 
      Torregalli 3, 50143, Florence, Italy.
FAU - Bandinelli, Francesca
AU  - Bandinelli F
AD  - Rheumatology Unit, Azienda Sanitaria di Firenze, S. Giovanni di Dio Hospital, Via 
      Torregalli 3, 50143, Florence, Italy.
FAU - Damiani, Arianna
AU  - Damiani A
AD  - Rheumatology Unit, Azienda Sanitaria di Firenze, S. Giovanni di Dio Hospital, Via 
      Torregalli 3, 50143, Florence, Italy.
FAU - Infantino, Maria
AU  - Infantino M
AD  - Allergology and Immunology Laboratory, S.Giovanni di Dio Hospital, Florence, 
      Italy.
FAU - Grossi, Valentina
AU  - Grossi V
AD  - Allergology and Immunology Laboratory, S.Giovanni di Dio Hospital, Florence, 
      Italy.
FAU - Manfredi, Mariangela
AU  - Manfredi M
AD  - Allergology and Immunology Laboratory, S.Giovanni di Dio Hospital, Florence, 
      Italy.
FAU - Parisi, Simone
AU  - Parisi S
AD  - Rheumatology Unit, Citta della Salute e della Scienza di Torino University 
      Hospital, Turin, Italy.
FAU - Fusaro, Enrico
AU  - Fusaro E
AD  - Rheumatology Unit, Citta della Salute e della Scienza di Torino University 
      Hospital, Turin, Italy.
FAU - Batticciotto, Alberto
AU  - Batticciotto A
AD  - Rheumatology Unit, L. Sacco University Hospital, Milan, Italy.
FAU - Sarzi-Puttini, Piercarlo
AU  - Sarzi-Puttini P
AD  - Rheumatology Unit, L. Sacco University Hospital, Milan, Italy.
FAU - Atzeni, Fabiola
AU  - Atzeni F
AD  - Rheumatology Unit, L. Sacco University Hospital, Milan, Italy.
FAU - Meacci, Francesca
AU  - Meacci F
AD  - Allergology and Immunology Laboratory, S.Giovanni di Dio Hospital, Florence, 
      Italy.
LA  - eng
PT  - Journal Article
PT  - Observational Study
PL  - United States
TA  - Immunol Res
JT  - Immunologic research
JID - 8611087
RN  - 0 (Antibodies)
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Biosimilar Pharmaceuticals)
RN  - B72HH48FLU (Infliximab)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies/blood
MH  - Antirheumatic Agents/adverse effects/immunology/*therapeutic use
MH  - Biosimilar Pharmaceuticals/adverse effects/*therapeutic use
MH  - Humans
MH  - Infliximab/adverse effects/immunology/*therapeutic use
MH  - Middle Aged
MH  - Spondylitis, Ankylosing/*drug therapy
MH  - Young Adult
OTO - NOTNLM
OT  - Biosimilar
OT  - CT-P13
OT  - Spondyloarthritis
OT  - Switching
EDAT- 2016/07/28 06:00
MHDA- 2018/02/21 06:00
CRDT- 2016/07/25 06:00
PHST- 2016/07/28 06:00 [pubmed]
PHST- 2018/02/21 06:00 [medline]
PHST- 2016/07/25 06:00 [entrez]
AID - 10.1007/s12026-016-8843-5 [pii]
AID - 10.1007/s12026-016-8843-5 [doi]
PST - ppublish
SO  - Immunol Res. 2017 Feb;65(1):419-422. doi: 10.1007/s12026-016-8843-5.