Additional Relevant Details
A separation between OTEZLA and placebo was seen at week 2, the study's first efficacy assessment time point, with 16.4 percent of patients in the OTEZLA arm achieving ACR20, compared with 6.4 percent in the placebo arm. Improvements versus placebo were also seen at week 2 in 28-joint count Disease Activity Score (C-reactive protein) [−0.59 vs. −0.31, respectively], health assessment questionnaire disability index (HAQ-DI) [−0.13 vs. −0.05], morning stiffness severity [42.7 percent vs. 21.1 percent], and enthesitis (inflammation at sites where tendons or ligaments insert into bone), as measured by a change in Gladman Enthesitis Index (GEI) [−1.1 vs. −0.4]. A trend to decrease in swollen joint count was also observed in patients receiving OTEZLA compared with those on placebo (−27.7 percent for OTEZLA vs. −17.5 percent for placebo).At week 16, 38.2 percent of patients in the OTEZLA arm achieved an ACR20 response, compared with 20.2 percent in the placebo arm. Improvements were also seen at week 16 in other measures of disease, including: 28-joint count Disease Activity Score (C-reactive protein) (−1.07 with OTEZLA vs. −0.39 with placebo), swollen joint count (−46.4 percent vs. 4.2 percent, respectively), HAQ-DI (−0.21 vs. −0.06), improvement in morning stiffness severity (46.4 percent vs. 25.7 percent), and enthesitis (−1.5 vs. −0.4).At week 24, placebo patients crossed over to active treatment with OTEZLA. Responses demonstrated in the placebo-controlled phase were maintained through week 52. For patients who were on OTEZLA from baseline, ACR20, ACR50, and ACR70 response rates at week 52 were 67.1 percent, 36.7 percent and 21.3 percent, respectively, and observed percent change in swollen joint count was −77.5 percent. Among patients who had enthesitis at baseline, GEI of 0 was 69.8 percent.The most commonly reported adverse events during the placebo-controlled period were nasopharyngitis (8.3 percent with OTEZLA vs. 6.4 percent with placebo), nausea (8.3 percent vs. 1.8 percent, respectively), headache (7.3 percent vs. 3.7 percent), hypertension (6.4 percent vs. 6.4 percent), diarrhea (14.7 percent vs. 11.0 percent) and upper respiratory tract infection (4.6 percent vs. 10.1 percent). Serious adverse events in the OTEZLA and placebo arms were 2.8 percent and 4.6 percent, respectively. No increase in adverse event incidence or severity was seen through week 52.