Tofacitinib Bests Placebo in Psoriatic Arthritis Trial

A research team based in Brazil presented data during the European Congress of Rheumatology (EULAR) 2020 virtual meeting on using tofacitinib, an oral Janus kinase inhibitor, to treat psoriatic arthritis.

An international task force has generally agreed that remission and low disease activity are treatment targets for patients with psoriatic arthritis. These recommendations include using the Disease Activity Index in Psoriatic Arthritis (DAPSA) and minimal disease activity (MDA) to assess disease activity states.

In the post hoc analysis, the investigators compared DAPSA LDA with MDA, as well as DAPSA remission with very low disease activity and DAS28-3 (CRP) remission, in patients with psoriatic arthritis receiving tofacitinib.

The team pooled data from a pair of phase 3 studies including the 12-month OPAL Broaden study and the 6-month OPAL Beyond trial. In these trials, 709 patients received either tofacitinib 5 (n = 237) or 10 mg (n = 236) twice daily or placebo (n = 236).

The investigators determined DAPSA by summing, swollen joint count (SJC66), tender/painful joint count (TJC68), Patient’s Global Assessment of Arthritis (PtG, visual analogue scale [VAS]), pain (VAS), and CRP.

Patients in the study were classified as achieving MDA or very low disease activity when meeting at least 5 MDA or 7 very low disease activity based on either JC68 ≤1, SJC66 ≤1, Psoriasis Activity and Severity Index ≤1 or body surface area ≤3%, pain (VAS) ≤15, PtGA (VAS) ≤20, HAQ-DI ≤0.5, or tender entheseal points (using Leeds Enthesitis Index [LEI]) ≤1.

The investigators used a logistic regression model to assess demographic and baseline characteristics as predictors of a trend in DAPSA scores at month 3.

They also compared DAPSA LDA (≤14), MDA, DAPSA remission (DAPSA ≤4), VLDA and DAS28-3(CRP) remission (DAS28-3[CRP]<2.6) rates at month 1, 3, and 6 for patients receiving tofacitinib 5 mg BID and at month 6 for patients receiving tofacitinib 5 or 10 mg BID.

The investigators evaluated agreement between disease activity indices at month 6 using a kappa test and reported the percentage of treatment patients who achieved MDA, very low disease activity, and non-response at month 6, stratified by achievement of DAPSA LDA, remission or non-response.

The investigators found that at month 3, older patients with higher baseline SJC66, TJC68, PtGA VAS, HAQ-DI, LEI and Pain VAS, were significantly (P <0.05) more likely to have higher DAPSA.

They also found that DAPSA LDA, MDA, remission (DAPSA and DAS28-3[CRP]) and very low disease activity rates generally increased from month 1 to month 6 for patients receiving tofacitinib 5&thinsp;mg BID.

At month 6, the patients receiving the study drug achieved MDA and all patients received very low disease activity and were also in DAPSA remission or LDA.

At least moderate agreement (defined by kappa values 0.41—0.60) was observed between DAPSA LDA and MDA, and between DAPSA remission and VLDA, with both doses of tofacitinib at month 6.

“Remission and LDA rates generally increased over time in patients with PsA receiving tofacitinib,” the authors wrote. “DAPSA LDA showed moderate agreement with MDA, and DAPSA remission showed at least moderate agreement with VLDA, confirming that DAPSA and MDA are useful measurement tools to assess disease activity in patients with PsA treated with tofacitinib.”

The study, “Comparison of Different Remission Indices in Patients with Psoriatic Arthritis: A Post Hoc Analysis of Data from Phase 3 Tofacitinib Studies,” was published online by EULAR.