Phase 3
Completed N=376
Comparative Efficacy and Safety Study of GP2015 and Enbrel® in Patients With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT02638259 ↗Enrolled (actual)
376
Serious AEs
2.6%
Results posted
Feb 2018
Primary outcomePrimary: Safety: Change in DAS28-CRP Score From Baseline to Week 24 in Patients Treated With GP2015 and Patients Treated With Enbrel — -2.80; -2.73 scores on a scale
◆ Published Evidence
Established
41citations · ~5 / year
Efficacy, safety and immunogenicity of GP2015, an etanercept biosimilar, compared with the reference etanercept in patients with moderate-to-severe rheumatoid arthritis: 24-week results from the comparative phase III, randomised, double-blind EQUIRA study.
Summary
Demonstrate equivalent efficacy of GP2015 and EU-authorized Enbrel in patients with moderate to severe, active (RA) who had an inadequate response to disease modifying anti-rheumatic drugs (DMARD) including methotrexate (MTX).
Linked Publications (3)
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Efficacy, safety and immunogenicity of GP2015, an etanercept biosimilar, compared with the reference etanercept in patients with moderate-to-severe rheumatoid arthritis: 24-week results from the comparative phase III, randomised, double-blind EQUIRA study.
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Switch from reference etanercept to SDZ ETN, an etanercept biosimilar, does not impact efficacy, safety, and immunogenicity of etanercept in patients with moderate-to-severe rheumatoid arthritis: 48-week results from the phase III, randomized, double-blind EQUIRA study.
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Patient-Reported Outcome Measures in Patients with Rheumatoid Arthritis, Psoriasis, or Psoriatic Arthritis Treated with GP2015, an Etanercept Biosimilar: Results from Two Phase III Studies (EGALITY and EQUIRA).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety: Change in DAS28-CRP Score From Baseline to Week 24 in Patients Treated With GP2015 and Patients Treated With Enbrel |
-2.80; -2.73 | — |
| SECONDARY Treatment Period 1: Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel |
13; 35; 1; 5; 0; 0 | — |
| SECONDARY Treatment Period 1 - Safety : Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients |
2; 0; 2; 5; 3; 42 | — |
| SECONDARY Treatment Period 1- DAS28-CRP and DAS28-erythrocyte Sedimentation Rate (ESR) Scores at Baseline and Weeks 4, 12 and 24; |
5.42; 5.53; 3.81; 3.82; 3.15; 3.31 | — |
| SECONDARY Treatment Period 1 - Changes From Baseline in DAS28-CRP and DAS-ESR Scores to Weeks 4, 12 and 24 |
-1.59; -1.70; -2.23; -2.20; -2.78; -2.78 | — |
| SECONDARY Treatment Period 1- Proportion of Patients Achieving EULAR Response |
26; 21; 54; 47; 88; 74 | — |
| SECONDARY Treatment Period 1- Proportion of Patients Achieving DAS28 < 2.6 at Weeks 4, 12 and 24 |
9; 7; 21; 21; 46; 41 | — |
| SECONDARY Treatment Period 1- Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria |
1; 2; 9; 8; 24; 15 | — |
| SECONDARY Treatment Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24; |
80; 83; 131; 116; 147; 144 | — |
| SECONDARY Treatment Period 1- ACR-N Scores at Weeks 4, 12 and 24; |
19.9; 22.6; 38.3; 38.7; 55.4; 59.4 | — |
| SECONDARY Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI |
0; 0; 0; 0; 26; 19 | — |
| SECONDARY Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI |
0; 0; 0; 0; 17; 7 | — |
| SECONDARY Treatment Period 1- Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 4, 12 and 24; |
11; 5; 22; 30; 40; 46 | — |
| SECONDARY Treatment Period 1 - Health Assessment Questionnaire (HAQ) Index at Baseline, Weeks 4, 12 and 24; |
1.44; 1.47; 1.19; 1.14; 1.02; 0.97 | — |
| SECONDARY Treatment Period 1 - Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 4, 12 and 24; |
27.0; 25.1; 31.6; 30.9; 34.4; 33.9 | — |
| SECONDARY Treatment Period 1 - CRP Levels at Baseline and Weeks 4, 12 and 24 |
1.19; 1.10; 0.36; 0.43; 0.33; 0.48 | — |
| SECONDARY Treatment Period 1 - ESR Levels at Baseline and Weeks 4, 12 and 24 |
41.4; 41.8; 26.5; 26.7; 23.2; 23.8 | — |
| SECONDARY Treatment Period 2: DAS28-CRP and DAS28-ESR Scores up to Week 48; |
5.45; 5.57; 3.89; 3.79; 3.20; 3.27 | — |
| SECONDARY Treatment Period 2 : Changes From Baseline in DAS28-CRP and DAS28-ESR Scores From Week 4 up to Week 48 |
-1.55; -1.76; -2.22; -2.27; -2.81; -2.90 | — |
| SECONDARY Treatment Period 2: Proportion of Patients Achieving EULAR Reponse |
20; 20; 43; 43; 77; 68 | — |
| SECONDARY Treatment Period 2 : Proportion of Patients Achieving DAS28 < 2.6 at Weeks 36 and 48; |
45; 38; 44; 35 | — |
| SECONDARY Treatment Period 2 : Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria |
0; 2; 9; 8; 22; 13 | — |
| SECONDARY Treatment Period 2 : Proportion of Patients Achieving ACR20/50/70 Response at Weeks 36 and 48; |
128; 114; 131; 108; 90; 83 | — |
| SECONDARY Treatment Period 2 : ACR-N Scores at Weeks 36 and 48; |
19.7; 24.9; 38.3; 40.7; 56.3; 60.9 | — |
| SECONDARY Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI |
0; 0; 0; 0; 20; 16 | — |
| SECONDARY Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI |
0; 0; 0; 0; 14; 6 | — |
| SECONDARY Treatment Period 2 :Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 36 and 48; |
8; 4; 17; 25; 33; 39 | — |
| SECONDARY Treatment Period 2 :HAQ Index at Weeks 36 and 48; |
1.47; 1.50; 1.22; 1.14; 1.04; 0.97 | — |
| SECONDARY Treatment Period 2 : Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 36 and 48; |
26.6; 25.5; 31.5; 31.3; 34.4; 34.1 | — |
| SECONDARY Treatment Period 2 : CRP Levels at Week 36 and 48 |
1.21; 1.17; 0.36; 0.42; 0.36; 0.50 | — |
| SECONDARY Treatment Period 2 : ESR Levels at Week 36 and 48 |
42.2; 41.7; 26.8; 25.3; 23.8; 23.0 | — |
| SECONDARY Safety - Overall Study : Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel |
13; 37; 1; 7; 0; 0 | — |
| SECONDARY Safety : Overall Study: Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients |
2; 0; 2; 5; 3; 42 | — |
Eligibility Criteria
Inclusion Criteria
- Patients at least 18 years of age with RA diagnosis according to ACR 1987 or ACR/EULAR 20110 criteria >/= 6 months at the time of baseline visit
- Patient must have active disease defined as DAS28-CRP>/=3.2
- Patients must have CRP level above ULN >5mg/l) or erythrocyte sedimentation rate (ESR) >/=28mm/h
- Patients must have inadequate clinical response to MTX at a dose of 10-25 mg/wk after proper dose escalation according to local standards
Exclusion Criteria
- Previous exposure to etanercept in the past
- Patients with functional status class IV according to the ACR 1991 revised criteria
- History of active tuberculosis (TB) or Presence of latent (inactive)TB detected by imaging and/or by the QuantiFERON-TB Gold test at screening
Data sourced from ClinicalTrials.gov (NCT02638259) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.