Positive Phase III SELECT-COMPARE study of upadacitinib for rheumatoid arthritis.-Abbvie.

AbbVie has announced positive top-line results from the Phase III SELECT-COMPARE clinical trial showing that after 12 weeks, upadacitinib (15 mg, once-daily) met the primary endpoints of ACR20a and clinical remission versus placebo. All ranked secondary endpoints were also achieved versus either placebo or adalimumab (40 mg every other week).

The ongoing study evaluates upadacitinib, an investigational oral JAK1-selective inhibitor, in patients with moderate to severe rheumatoid arthritis who are on a stable background of methotrexate and had an inadequate response. Upadacitinib is not approved by regulatory authorities and its safety and efficacy have not been established.

The study showed that at week 12, 71 percent of patients receiving an oral once-daily dose of upadacitinib 15 mg achieved an ACR20 response, compared with 36 percent of patients receiving placebo. A significantly higher proportion of patients receiving upadacitinib achieved clinical remission (based on Disease Activity 28 [DAS28] C-Reactive Protein [CRP]) compared with placebo at week 12 (29 percent versus 6 percent, respectively). Patients receiving upadacitinib achieved ACR50/70 responses of 45/25 percent compared to 15/5 percent of patients receiving placebo at week 12. Additionally low disease activity (LDA) based on DAS28(CRP) was seen in 45 percent of patients receiving upadacitinib compared to 29 percent receiving adalimumab and 14 percent receiving placebo at week 12, respectively.

Study findings also showed superiority of upadacitinib over adalimumab, on ranked secondary endpoints that compared both groups. At week 12, 45 percent of upadacitinib patients achieved ACR50 compared with 29 percent of adalimumab patients. Additionally, upadacitinib was superior to adalimumab in reduction of pain as measured by the Patient's Assessment of Pain (based on the Visual Analog Scale [VAS]), and improvements in physical function, as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI), at week 12.1 Following 26 weeks of treatment, upadacitinib (n=593) significantly inhibited radiographic progression as measured by the change in modified total Sharp score (mTSS) from baseline, compared to placebo (n=599) (0.24 versus 0.92, p<0.001). the inhibition of joint damage is important for rheumatoid arthritis patients as this can lead to permanent loss of function and subsequent disability. in this study the safety profile of upadacitinib was consistent with previously reported results. no new safety signals were detected.>

Additional results of SELECT-COMPARE, the fourth of six Phase III studies in the SELECT rheumatoid arthritis clinical trial program, will be presented at a future medical meeting and published in a peer-reviewed publication.