AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced positive top-line results from the Phase 3 SELECT-COMPARE clinical trial showing that after 12 weeks, upadacitinib (15 mg, once-daily) met the primary endpoints of ACR20a and clinical remissionb versus placebo.1 All ranked secondary endpoints were also achieved versus either placebo or adalimumab (40 mg every other week).1 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.1 Upadacitinib is not approved by regulatory authorities and its safety and efficacy have not been established.
"These results show a significant impact on both signs and symptoms and radiographic progression compared to placebo, as well as improvements in important measures such as ACR response and low disease activity compared to adalimumab," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "We are excited by these strong results which add to the body of evidence that support the potential of upadacitinib to be an important treatment option for patients with rheumatoid arthritis."
Rheumatoid arthritis, which affects an estimated 23.7 million people worldwide, is a chronic and debilitating disease.15 Despite the range of available treatments, many patients with rheumatoid arthritis still do not achieve clinical remission or low disease activity targets.16-18
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.1 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).1 Patients receiving upadacitinib achieved ACR50/70 responses of 45/25 percent compared to 15/5 percent of patients receiving placebo at week 12.1 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.1
SELECT-COMPARE Efficacy Results at Week 12†
------------------------------------------
Upadacitinib Adalimumab Placebo
(n=651)
15 mg 40 mg EOW
(n=651) (n=327)
------ ------
ACR20a 71%***# 63% 36%
------ ------- --- ---
ACR50a 45%***### 29% 15%
------ --------- --- ---
ACR70a 25%***### 13% 5%
------ --------- --- ---
Clinical
Remission
(DAS
28-CRP)b 29%***### 18% 6%
---------- --------- --- ---
Low
Disease
Activity
(DAS28-CRP)c 45%***### 29% 14%
------------- --------- --- ---
†Primary endpoints included ACR20
and clinical remission based on
DAS28(CRP) for upadacitinib versus
placebo (superiority). Ranked
secondary endpoints included ACR 50
versus adalimumab (both non-
inferiority and superiority) and
LDA versus adalimumab (non-
inferiority) and versus placebo
(superiority). All other
comparisons were not a...
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