AbbVie's Upadacitinib Meets Primary and Key Efficacy Endpoints in Phase 2b/3 Rheumatoid Arthritis Study

CP Staff
CP Staff
  • In SELECT-SUNRISE study, upadacitinib met the primary endpoint of ACR20 (An ACR20 score means that a person's RA has improved by 20%) across all doses (7.5 mg, 15 mg, 30 mg, once-daily) at week 12, with a significant difference in ACR20 compared to placebo observed as early as week one
  •  Significantly more patients receiving upadacitinib achieved ACR50, ACR70 and clinical remission at week 12 compared to placebo
  • The safety profile of upadacitinib was consistent with previously reported results, with no new safety signals detected
  • No deaths occurred and no reports of major cardiovascular events or reports of pulmonary embolism were made


AbbVie (NYSE: ABBV), On 4/25/18 announced positive results from the ongoing Phase 2b/3 SELECT-SUNRISE clinical trial, showing that at 12 weeks, all doses of upadacitinib (7.5 mg, 15 mg and 30 mg, once-daily) met the study's primary endpoint of ACR20 versus placebo. Certain key efficacy endpoints were also achieved versus placebo. The study, conducted in Japan, evaluates upadacitinib, an investigational oral JAK1-selective inhibitor, in adult Japanese patients with moderate to severe rheumatoid arthritis who are on a stable dose of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and have had an inadequate response to csDMARDs. These data will be presented during an oral presentation at the Japan College of Rheumatology (JCR) 2018 Annual Scientific Meeting in Tokyo on Saturday, April 28, 2018. Upadacitinib is not approved by regulatory authorities and its safety and efficacy have not been established.

"We are encouraged by these data, which show that upadacitinib provides improvements in important measures such as achieving ACR response and clinical remission, in people living with rheumatoid arthritis in Japan," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "SELECT-SUNRISE reflects our continued commitment to offering innovative solutions with the potential to improve the lives of Japanese patients living with this serious, debilitating condition."

Results at week 12 showed that of patients receiving an oral once-daily dose of upadacitinib 7.5/15/30 mg, 76/84/80 percent achieved ACR20, respectively, compared to 43 percent of patients receiving placebo  (p<0.001). As early as week one, significantly more patients on upadacitinib achieved ACR20 compared to placebo (31/25/34 percent in the 7.5/15/30mg upadacitinib groups, respectively, compared to 8 percent in the placebo group, p<0.01/0.05/0.01).Additionally, significantly more patients receiving upadacitinib also achieved ACR50 and ACR70 responses compared to placebo.1Among upadacitinib patients receiving the 7.5/15/30 mg doses, ACR50 was achieved by 41/65/58 percent, respectively, compared to 16 percent with placebo (p<0.01/0.001/0.001), and ACR70 was achieved by 20/35/28 percent, respectively, compared to 2 percent with placebo (p<0.01/0.001/0.001). The study also showed that a significantly higher proportion of upadacitinib patients across all doses achieved low disease activity and clinical remission at week 12 compared to patients receiving placebo.

Importantly, no new safety signals were reported. Deaths related to pulmonary embolism and stroke had occurred in previous studies. There were no deaths, no reports of major cardiovascular events and no reports of pulmonary embolism in the study.