Efficacy and safety of golimumab biosimilar BAT2506 in patients with active psoriatic arthritis after switching from reference golimumab: 52-week results of a phase 3, double-blind, randomized study.

What was studied

This trial tested a switch from reference golimumab to the biosimilar BAT2506. The patients had active psoriatic arthritis. This was the second period of a phase 3 study. It ran from Week 24 to Week 52. The study was double-blind. Patients were randomized 1:2:1. One group stayed on reference golimumab. One got BAT2506 throughout. One switched from reference golimumab to BAT2506 at Week 24. Doses were given every 4 weeks. 679 patients entered this period.

What they found

Assessments through Week 52 included ACR 20/50/70 responses and DAS28-CRP. They also covered safety, drug levels and antibodies. At Week 52, efficacy did not differ across groups. Adverse events were comparable across groups. No new safety signals appeared. Drug level profiles overlapped. Immunogenicity was comparable.

What it means for patients

The authors say switching to BAT2506 gave comparable results. This covered efficacy, safety, immunogenicity and PK profiles. They compare it with staying on BAT2506 or on reference golimumab.

Why it is not certain yet

The abstract gives no numbers for the efficacy scores. It covers only up to Week 52. Only patients who finished the first period entered this part. The abstract gives no cost results.

Source

Efficacy and safety of golimumab biosimilar BAT2506 in patients with active psoriatic arthritis after switching from reference golimumab: 52-week results of a phase 3, double-blind, randomized study.

We restate facts from the source record in our own words. The original wording belongs to its publisher.