In SELECT-COMPARE, 71 percent of MTX-IR patients treated with RINVOQ 15 mg plus MTX achieved ACR20
vs 36 percent treated with placebo plus MTX at week 121
The study achieved its primary endpoint in the proportion of patients achieving an ACR20
response at week 24.
In addition to the primary endpoint of ACR20
response at week 24, multiple secondary endpoints were assessed that included ACR50/70, resolution of soft tissue inflammation (enthesitis and dactylitis), disease activity (DAS-28 CRP), improvement in physical function (HAQ-DI), skin clearance (IGA), and quality of life (SF-36 PCS and MCS).
Overall, the proportions of patients achieving ACR20
, ACR50, and ACR70 increased progressively over time (Figure 2a), accompanied by a decrease in DAS28-ESR and DAS28-CRP scores (Figure 2b) and an increase in the proportion of patients achieving low disease activity (LDA; <3.2) and remission (<2.6) according to both DAS28-ESR and DAS28-CRP criteria (data not shown).
At Month 6, ACR20
response rates for patients treated with tofacitinib 5 and 10 mg BID were 67.4% and 70.6%, respectively, versus 34.1% for placebo-treated patients.
Ixekizumab given every 2 or 4 weeks also has demonstrated efficacy in PsA, with ACR20
rates of 62.1% (dosed at once every 2 weeks) and 57.9% (dosed at once every 4 weeks), compared with 30.2% for placebo (P<0.001) and 57.4% for adalimumab (statistical comparison to ixekizumab not performed) after 24 weeks of treatment.
Over half (60.0%) of the patients in silibinin group achieved ACR20
compared to 40.0% of patients in the placebo group, but the difference was not statistically significant [Table 3].
At 12th week, the ACR20
response rates were statistically significantly higher in tofacitinib groups than placebo and improvements continued at 24 weeks.
and DAS28, were employed to evaluate the clinical outcomes.
These patients must have active disease as shown in the following outcomes: (a) ACR20
; (b) tender joint count (TJC); (c) swollen joint count (SJC); (d) assessment of rest pain; (e) physician global assessment of disease activity; (f) patient global assessment of disease activity; (g) health assessment questionnaire (HAQ) score; (h) erythrocyte sedimentation rate (ESR); (i) C-reactive protein (CRP); and (j) adverse events reports.
In a trial of Careram in combination with MTX(1) conducted in this patient population, patients who were administered a combination of the two agents demonstrated favorable tolerability as well as significant improvements compared to those treated with placebo (MTX-only arm) in the study's primary endpoint of ACR20
response rate at Week 24.
In the first primary endpoint, the 315-patient treatment cohort improved with an ACR20
response of 52%, while on the twice daily 5mg dose compared to the placebo group (no response reported).