Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GP2015, Etanercept
GP2015 Etanercept · 2 trials · 2 indications
Disease activity score (DAS) 28-CRP is based on 28-joint count (tender and swollen joints), C-reactive protein and patient's assessment of global disease activity, values range from 0.96 to 10.0 while higher values mean a higher disease activity. • A DAS28-CRP value \>5.1 corresponds to a high disease activity • A DAS28-CRP value between 3.2 and 5.1 corresponds to a moderate disease activity • A DAS28-CRP value between 2.6 and 3.2 corresponds to a low disease activity • A DAS28-CRP value \< 2.6 corresponds to remission DAS28-CRP = 0.56 \* sqrt(tender28) + 0.28\* sqrt(swollen28) + 0.36 \* ln(CRP+1) + 0.014 \* GDA + 0.96 where • tender28 and swollen28 are the number of tender and swollen joints as assessed using 28-joint count • CRP is C-reactive protein (mg/l) • GDA is the global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm
The 95% CI for the Psoriasis Area and Severity Index (PASI) 75 response rate differences at Week12 between GP2015 Etanercept and Enbrel ® Etanercept. PASI 75 response: patients who achieved ≥ 75% improvement (reduction) in PASI score compared to baseline were defined as PASI 75 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretic maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity.
| Arm | Type | Description |
|---|---|---|
| 50mg GP2015 | EXPERIMENTAL | Group 1 will receive treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continue treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). |
| 50mg EU-authorized Enbrel | ACTIVE_COMPARATOR | Group 2 will receive treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response will be switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). |
| GP2015 Etanercept | EXPERIMENTAL | Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter |
| Enbrel ® Etanercept | ACTIVE_COMPARATOR | Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter |
| Name | Type | Description |
|---|---|---|
| GP2015 | DRUG | Enbrel comparator |
| GP2015 Etanercept | DRUG | Sandoz has developed GP2015 Etanercept (Sandoz's code for the drug product containing the active ingredient etanercept) to be biosimilar to Enbrel. |
| Enbrel | DRUG | Enbrel is used as reference product to GP2015. |
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 sed...
GP2015 Etanercept is used for the treatment of chronic stable plaque psoriasis, a skin condition characterized by raised, inflamed, and scaly patches. It is being developed as a biosimilar to Enbrel, with the goal of demonstrating equivalent efficacy and comparable safety in patients with this condition.
GP2015 Etanercept is being developed by Novartis AG, a multinational pharmaceutical company headquartered in Basel, Switzerland. Novartis is listed on the stock exchange under the ticker symbol NVS.
GP2015 Etanercept is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the results will inform potential regulatory submissions for approval.
GP2015 Etanercept has been studied in one Phase 3 clinical trial with the identifier NCT01891864. This trial, titled 'Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Etanercept (GP2015) and Enbrel', enrolled 531 participants with chronic stable plaque psoriasis and has been completed.
GP2015 Etanercept is a biosimilar to Enbrel, meaning it is designed to be highly similar to the reference biologic Enbrel. The Phase 3 trial was conducted to demonstrate equivalent efficacy and comparable safety between GP2015 Etanercept and Enbrel in patients with chronic stable plaque psoriasis.
GP2015 Etanercept is a biosimilar to etanercept, which works by binding to tumor necrosis factor (TNF), a cytokine involved in systemic inflammation. By neutralizing TNF, it reduces the inflammatory response that contributes to the development of psoriatic plaques.