title: Clinical effectiveness of CT-P13 (Infliximab biosimilar) used as a switch from Remicade (infliximab) in patients with established rheumatic disease. Report of clinical experience based on prospective observational data.
abstract: OBJECTIVE
  To gain clinical experience on the effectiveness and safety of switching from infliximab-Remicade(INX) to infliximab-biosimilar-CT-P13(INB) in patients with established rheumatic disease.
  
  
  METHODS
  Patients receiving INX treatment at a rheumatology clinic consented to switching from INX to INB. Patient reported outcomes (PROs), disease-activity, and inflammatory markers were recorded at every visit. Generalized estimating equation models and time-dependent area under the curve (AUC) before/during INX and INB treatments were employed.
  
  
  RESULTS
  Thirty-nine consecutive patients [mean (SD) age 53 (11), 17 F] with various rheumatic diseases were switched to INB after a mean (SD) of 4.1 (2.3) years on INX. Thirty-one patients were on concomitant methotrexate. At a median (range) of 11 (7.5-13) months following the first administration of INB, AUCs for disease activity and PROs were similar for INX and INB. They were better compared to those prior to INX. Eleven patients (28.2%) discontinued INB, due to INX antidrug antibodies detected prior to INB infusion (n = 3); latent tuberculosis (n = 1); new-onset neurofibromatosis (n = 1); subjective reasons with no objective deterioration of disease (n = 6).
  
  
  CONCLUSIONS
  The clinical effectiveness of INB in both PROs and disease-activity measures was comparable to INX during the first year of switching, with no immediate safety signals. Subjective reasons (negative expectations) may play a role among discontinuations of biosimilars. Larger patient numbers and longer follow-up are necessary for confirming this clinical experience.
authors.affiliation: a Jyväskylä Central Hospital , Rheumatology Research Department , Jyväskylä , Finland.
authors.forename: Elena
authors.initials: E
authors.lastname: Nikiphorou
authors.affiliation: b Medcare Foundation , Äänekoski , Finland.
authors.forename: Hannu
authors.initials: H
authors.lastname: Kautiainen
authors.affiliation: a Jyväskylä Central Hospital , Rheumatology Research Department , Jyväskylä , Finland.
authors.forename: Pekka
authors.initials: P
authors.lastname: Hannonen
authors.affiliation: a Jyväskylä Central Hospital , Rheumatology Research Department , Jyväskylä , Finland.
authors.forename: Juha
authors.initials: J
authors.lastname: Asikainen
authors.affiliation: a Jyväskylä Central Hospital , Rheumatology Research Department , Jyväskylä , Finland.
authors.forename: Arto
authors.initials: A
authors.lastname: Kokko
authors.affiliation: a Jyväskylä Central Hospital , Rheumatology Research Department , Jyväskylä , Finland.
authors.forename: Tuomas
authors.initials: T
authors.lastname: Rannio
authors.affiliation: a Jyväskylä Central Hospital , Rheumatology Research Department , Jyväskylä , Finland.|c University of Eastern Finland , Faculty of Health Sciences, Head of Rheumatology , Jyväskylä Central Hospital, 40620 Jyväskylä , Finland.
authors.forename: Tuulikki
authors.initials: T
authors.lastname: Sokka
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D018501:Antirheumatic Agents / Q000008:administration & dosage*; D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage; D057915:Drug Substitution / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000069285:Infliximab / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012216:Rheumatic Diseases / Q000175:diagnosis / Q000188:drug therapy*; D057566:Self Report; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D059451:Biosimilar Pharmaceuticals; C000591237:CT-P13; D000069285:Infliximab
keywords: ankylosing spondylitis; biosimilars infliximab; rheumatoid arthritis