Efficacy and safety of deucravacitinib, an oral, selective tyrosine kinase 2 inhibitor, in patients with active psoriatic arthritis: 52-week results from the randomised, double-blind, placebo-controlled phase 3 POETYK PsA-1 trial.

What was studied

This trial tested deucravacitinib in adults with active psoriatic arthritis (PsA). Deucravacitinib is an oral drug that blocks tyrosine kinase 2. POETYK PsA-1 was a randomised, double-blind, placebo-controlled phase 3 trial. Patients had not used biologic disease-modifying drugs. They had raised C-reactive protein. They also had at least 1 hand or foot erosion on X-ray. Patients were randomised 1:1 to deucravacitinib or placebo until week 16. The dose was 6 mg once daily. After that, all received deucravacitinib through week 52. The main end point was ACR20 response at week 16.

What they found

670 patients took part. More patients on deucravacitinib reached ACR20 at week 16 than on placebo (p < .001). The rates were 54.2 versus 34.1, as shares of patients. Responses rose further by week 52. People who switched from placebo reached similar gains to those on continuous treatment. Structural damage was inhibited at weeks 16 and 52. Serious adverse events were low (1.8 versus 2.4). Stopping due to side effects was low too (2.4 versus 1.8). No new safety signals were found. No one died. Heart events, cancers and opportunistic infections were not imbalanced.

What it means for patients

The team says deucravacitinib was superior to placebo for clinical response. This held for patient-reported outcomes and structural damage. They say it was well tolerated and safe.

Why it is not certain yet

The structural damage result came from a post hoc analysis. The main end point used nonresponder imputation for missing data. The abstract gives no other limits.

Source

Efficacy and safety of deucravacitinib, an oral, selective tyrosine kinase 2 inhibitor, in patients with active psoriatic arthritis: 52-week results from the randomised, double-blind, placebo-controlled phase 3 POETYK PsA-1 trial.

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