Table 1

Randomised clinical trials, extension studies and observational studies of switching from originator TNF-α inhibitors to biosimilars in inflammatory rheumatic diseases.

Reference studyPatients (n)DiseaseReference product/biosimilarPrimary endpointClinical resultsImmunogenicity (presence of ADAb)
 NIkiphorou14 39RA (38%)
AS and ReA (39%)
PsA (18%)
JIA (5%)
IFX/CT-P13PROs (HAQ, pain, fatigue and morning stiffness)
Disease activity (VAS patient)
Patient symptoms and disease activity were similar during IFX and CT-P13.ND
Extension study15
Switch IFX originator to CT-P13: 144
RAIFX/CT-P13ACR20 at week 102Maintenance: 71.7%
Switch: 71.8%
Maintenance: 40.3%
Switch: 44.8%
Extension study16
Maintenance CT-P13: 88
Switch IFX originator to CT-P13: 86
ASIFX/CT-P13ASAS20 week 102Maintenance group: 80.7%
Switch group: 76.9%
Maintenance: 23.3%
Switch: 27.4%
SB4 extension study20 245
Maintenance SB4: 126
Switch originator to SB4: 119
RAETA/SB4ACR20 week 100Maintenance group: 80%
Switch group: 80%
SB2 transition study18 Switch IFX to SB2: 94
Maintenance SB2: 101
Maintenance IFX: 201
RAIFX/SB2Change in DAS28 at week 78Comparable change between the three groupsSwitch IFX to SB2: 14.6
Maintenance SB2: 14.1
Maintenance IFX:14.9
SB5 transition study21 Maintenance SB5: 254
Switch ADL to SB5: 125
Maintenance ADL: 129
RAADL/SB5ACR20 week 42Maintenance SB5: 76.9
Switch ADL to SB5: 81.1
Maintenance ADL:71.2
Maintenance SB5: 15.7
Switch ADL to SB5: 16.8
Maintenance ADL: 18.3
Maintenance originator IFX: 241
Switch: 240
RA: 77
SpA: 91
PsA: 30
Other (CD, UC, Pso): 283
IFX/CT-P13Worsening of the disease according to specific clinical endpointMaintenance: 26.2%
Switch: 29.6%
Maintenance: 7.1%
Switch: 7.9%
DANBIO23 768
All switch
RA: 364
SpA: 256
PsA: 119
Other: 29
IFX/CT-13Disease flare at month 3Unchanged disease and flare 3 months prior to versus 3 months after switchNo difference of ADAb positivity between baseline and at 6 months after switching
DANBIO24 1548RA: 891
SpA: 322
PsA: 335
ETA/SB4Disease flare at month 3Unchanged disease and incidence of flare prior versus after switchND
  • ACR20, American College of Rheumatology 20; ADL, adalimumab; ADAb, antidrug antibodies; AS, ankylosing spondylitis; ASAS20, Assessement in Anlylosing Spondylitis; CD, Crohn’s disease; DAS28, disease activity score 28 joints; DANBIO, a nationwide registry of biological therapies in Denmark; HAQ, Health Assessment Questionnaire; 

  • IFX, infliximab; ETA, etanercept; JIA, juvenile idiopathic arthritis; ND, not determined; NOR-SWITCH, Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab; PLANETRA, A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis; PLANETAS, A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis; PRO, patient-reported outcome; PsA, psoriatic arthritis; Pso, psoriasis; RA, rheumatoid arthritis; ReA, reactive arthritis; SpA, spondyloarthritis; TNF-α, tumour necrosis factor-α; UC, ulcerative colitis; VAS, Visual Analogue Scale.