SAFETY AND EFFICACY OF DEUCRAVACITINIB, AN ORAL, SELECTIVE TYROSINE KINASE 2 INHIBITOR, IN PATIENTS WITH PSORIATIC ARTHRITIS: 52 WEEK RESULTS FROM A RANDOMIZED PHASE 2 TRIAL
Authors: Mease PJ et al.
Deucravacitinib is an oral, selective inhibitor of tyrosine kinase 2 (TYK2) and interferes with TYK2 dependent cytokines, among which is IL-23 that is involved in the pathogenesis of psoriasis and psoriatic arthritis. In the initial 16-week, placebo-controlled trial phase of a 52-week RCT, deucravacitinib was significantly more effective than placebo and well tolerated. Now the 52-week results of this trial are presented. Patients had received either placebo or deucravatinib at 6mg or 12 mg once daily. Treatment remained blinded between week 16 and week 52. Patients on DEUC who had achieved minimal disease activity (MDA) at week 16 continued DEUC treatment and those who had not achieved MDA were switched to ustekinumab (UST). All patients treated with PBO in Part A switched to UST in Part B.
The majority of patients who completed 16 weeks of treatment chose to enroll in Part B. Of 118 patients initially randomized to DEUC, 25% (29/118; 6 mg QD, 22% [13/60]; 12 mg QD, 28% [16/58]) achieved MDA at week 16 and continued at the same dose. All other patients switched to UST in Part B. No new safety signals occurred with DEUC. All AEs were mild or moderate except 2 AEs in 1 patient with severe cataract/macular fibrosis. There were no opportunistic infections, herpes zoster, malignancy or thrombotic events in patients on DEUC. Decreases in mean PASDAS score and improvements in other clinical and patient-reported outcomes, observed at week 16, were maintained until week 52 in patients who continued on DEUC. Patients who had not achieved MDA on DEUC at week 16 showed a decrease in mean PASDAS score at week 52 after switching to UST.
Deucravacitinib may develop into a potent orally available drug in PsA. Thus far, no thromboembolic events or cases of herpes zoster were observed, but due to the limited number of patients involved, this remains to be determined in future trials. Of interest, DEUC is also currently being explored in SLE and I am sure, we will here more from this compound.