title: Safety, efficacy and immunogenicity of switching from innovator to biosimilar infliximab in patients with spondyloarthritis: a 6-month real-life observational study.
abstract: 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 μg/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.
authors.affiliation: Rheumatology Unit, Azienda Sanitaria di Firenze, S. Giovanni di Dio Hospital, Via Torregalli 3, 50143, Florence, Italy. maubenucci@tiscali.it.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Benucci
authors.affiliation: Rheumatology Unit, Azienda Sanitaria di Firenze, S. Giovanni di Dio Hospital, Via Torregalli 3, 50143, Florence, Italy.
authors.forename: Francesca Li
authors.initials: FL
authors.lastname: Gobbi
authors.affiliation: Rheumatology Unit, Azienda Sanitaria di Firenze, S. Giovanni di Dio Hospital, Via Torregalli 3, 50143, Florence, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Bandinelli
authors.affiliation: Rheumatology Unit, Azienda Sanitaria di Firenze, S. Giovanni di Dio Hospital, Via Torregalli 3, 50143, Florence, Italy.
authors.forename: Arianna
authors.initials: A
authors.lastname: Damiani
authors.affiliation: Allergology and Immunology Laboratory, S.Giovanni di Dio Hospital, Florence, Italy.
authors.forename: Maria
authors.initials: M
authors.lastname: Infantino
authors.affiliation: Allergology and Immunology Laboratory, S.Giovanni di Dio Hospital, Florence, Italy.
authors.forename: Valentina
authors.initials: V
authors.lastname: Grossi
authors.affiliation: Allergology and Immunology Laboratory, S.Giovanni di Dio Hospital, Florence, Italy.
authors.forename: Mariangela
authors.initials: M
authors.lastname: Manfredi
authors.affiliation: Rheumatology Unit, Città della Salute e della Scienza di Torino University Hospital, Turin, Italy.
authors.forename: Simone
authors.initials: S
authors.lastname: Parisi
authors.affiliation: Rheumatology Unit, Città della Salute e della Scienza di Torino University Hospital, Turin, Italy.
authors.forename: Enrico
authors.initials: E
authors.lastname: Fusaro
authors.affiliation: Rheumatology Unit, L. Sacco University Hospital, Milan, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Batticciotto
authors.affiliation: Rheumatology Unit, L. Sacco University Hospital, Milan, Italy.
authors.forename: Piercarlo
authors.initials: P
authors.lastname: Sarzi-Puttini
authors.affiliation: Rheumatology Unit, L. Sacco University Hospital, Milan, Italy.
authors.forename: Fabiola
authors.initials: F
authors.lastname: Atzeni
authors.affiliation: Allergology and Immunology Laboratory, S.Giovanni di Dio Hospital, Florence, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Meacci
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000906:Antibodies / Q000097:blood; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D000069285:Infliximab / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D008875:Middle Aged; D013167:Spondylitis, Ankylosing / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D000906:Antibodies; D018501:Antirheumatic Agents; D059451:Biosimilar Pharmaceuticals; D000069285:Infliximab
keywords: Biosimilar; CT-P13; Spondyloarthritis; Switching