Erelzi

Published Trial Results

Pivotal Trial for Approval: Rheumatoid Arthritis

A study comparing GP2015 to Enbrel in subjects with rheumatoid arthritis (EQUIRA)

A phase III randomized, double-blind study in patients with moderate-to-severe rheumatoid arthritis who had an inadequate response to methotrexate 10–25 mg/wk compared GP2015 and the EU-licensed version of Enbrel for 24 weeks. After 24 weeks, those patients with at least a moderate clinical response continued treatment (for up to 48 weeks).

Patients self-administered subcutaneously GP2015 or etanercept 50 mg/wk during the initial study period. Methotrexate (10–25 mg/wk) and folic acid (≥ 5 mg/wk) were used concomitantly during the study. The primary endpoint was the change after 24 weeks in DAS28-CRP (Disease Activity Score using C-reactive protein) from baseline.

Analysis of the data showed a least-squares means difference of –0.04, 95% CI: –0.24, 0.15), indicating the products were equivalent.

Other results at 24 weeks:

Treatment-emergent adverse events were similar between the two groups (43.5% for GP2015 vs. 49.5% for etanercept) as were the severe adverse events (0.5% vs. 3.2%, respectively). The etanercept group had more injection-site reactions than did the GP2015 group (17.9% vs 7.0%, respectively). None of the patients had significant levels of antidrug antibodies (ADAs) detected.

Results at 48 weeks:

At 48 weeks, there were more treatment-emergent adverse events in the patients who continued with GP2015 treatment than in the group switching to GP2015 (42.9% vs 38.0%, respectively) but there were fewer serious adverse events in the continued treatment group (2.3% vs. 2.4%, respectively). No patients had injection site reactions in the continued GP2015 group while 3.6% of the switched group did.

Pivotal Trial for Approval: Psoriasis

A study to demonstrate equivalent efficacy and to compare safety of biosimilar GP2015 and Enbrel in patients with chronic stable plaque psoriasis (EGALITY). Approval of GP2015 was based on efficacy results at week 12 of this study but included all adverse events noted through 52 weeks.

A phase III randomized double-blind trial with 531 patients with clinically stable chronic plaque-type psoriasis who had previously received treatment with phototherapy or other systemic psoriasis treatment received either GP2015 50 mg or EU-licensed Enbrel 50 mg twice weekly via the subcutaneous route for 12 weeks. If as of 12 weeks the participants had achieve ≥50% improvement in Psoriasis Area and Severity Index (PASI) score, they were re-randomized to either to continue the same treatment with a weekly dosing schedule or to switch therapies every 6 weeks with weekly dosing until week 30 and then continue with weekly dosing with that final therapy until week 52.

The primary outcome measure was the difference in PASI 75 response rates at week 12 between the two treatment groups. The PASI 75 response rate was 73.4% in the GP2015 group and 75.7% in the etanercept group (a difference of –2.3%, CI –9.85 to 5.30), demonstrating therapeutic equivalency.

Other results at week 12:

Adverse events reported reflected 52 weeks of treatment. Patients receiving GP2015 for 52 weeks had more treatment-emergent adverse events than the patients receiving etanercept (N=98 for both groups, 59.8% vs. 57.3%, respectively). For the patients starting with GP2015 and then initially switching to EU-etanercept there were more treatment-emergent adverse event than the group initially switching to GP2015 (N=61 vs. 57; 61% vs. 59%, respectively). Injection site reactions were seen more often in the etanercept group than the GP2015 group during the first 12 weeks (14.2% vs. 4.9%, respectively) and these groups that continued their initial drug at 52 weeks (15.8% vs 8.5%, respectively). During the first 12 weeks of the study five patients in the etanercept group had ADA levels detected during the first four weeks of the study that were then negative after that time frame. In the group switched to EU-etanercept but currently receiving GP2015 one patient had positive ADA results.

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