Randomised clinical trials, extension studies and observational studies of switching from originator TNF-α inhibitors to biosimilars in inflammatory rheumatic diseases.
| Reference study | Patients (n) | Disease | Reference product/biosimilar | Primary endpoint | Clinical results | Immunogenicity (presence of ADAb) |
| NIkiphorou14 | 39 | RA (38%) AS and ReA (39%) PsA (18%) JIA (5%) | IFX/CT-P13 | PROs (HAQ, pain, fatigue and morning stiffness) Disease activity (VAS patient) | Patient symptoms and disease activity were similar during IFX and CT-P13. | ND |
| PLANETRA Extension study15 | 302 Maintenance: 158 Switch IFX originator to CT-P13: 144 | RA | IFX/CT-P13 | ACR20 at week 102 | Maintenance: 71.7% Switch: 71.8% | Maintenance: 40.3% Switch: 44.8% |
| PLANETAS Extension study16 | 174 Maintenance CT-P13: 88 Switch IFX originator to CT-P13: 86 | AS | IFX/CT-P13 | ASAS20 week 102 | Maintenance 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 | RA | ETA/SB4 | ACR20 week 100 | Maintenance group: 80% Switch group: 80% | ND |
| SB2 transition study18 | Switch IFX to SB2: 94 Maintenance SB2: 101 Maintenance IFX: 201 | RA | IFX/SB2 | Change in DAS28 at week 78 | Comparable change between the three groups | Switch 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 | RA | ADL/SB5 | ACR20 week 42 | Maintenance 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 |
| NOR-SWITCH22 | 481 Maintenance originator IFX: 241 Switch: 240 | RA: 77 SpA: 91 PsA: 30 Other (CD, UC, Pso): 283 | IFX/CT-P13 | Worsening of the disease according to specific clinical endpoint | Maintenance: 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-13 | Disease flare at month 3 | Unchanged disease and flare 3 months prior to versus 3 months after switch | No difference of ADAb positivity between baseline and at 6 months after switching |
| DANBIO24 | 1548 | RA: 891 SpA: 322 PsA: 335 | ETA/SB4 | Disease flare at month 3 | Unchanged disease and incidence of flare prior versus after switch | ND |
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.