AbbVie (ABBV) Says Upadacitinib (ABT-494) Met All Primary and Ranked Secondary Endpoints in Phase 3 Study in RA

June 7, 2017 7:59 AM EDT

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AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced positive top-line results from the Phase 3 SELECT-NEXT clinical trial evaluating upadacitinib (ABT-494), an investigational oral JAK1-selective inhibitor, in patients with moderate to severe rheumatoid arthritis (RA) who did not adequately respond to treatment with conventional synthetic DMARDs (csDMARDs).1 Results showed that after 12 weeks of treatment, both doses of upadacitinib (15 mg and 30 mg) met the study's primary endpoints of ACR20 and low disease activity.1 Key secondary endpoints were also achieved and included ACR50, ACR70 and clinical remission.1 Full results will be presented at an upcoming medical meeting and published in a peer-reviewed publication. Upadacitinib is an investigational oral agent and is not approved by regulatory authorities.

"We are excited by these promising results for upadacitinib. Selective inhibition of the JAK1 pathway may offer a novel treatment for rheumatoid arthritis patients who do not adequately respond to conventional therapies," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "We are especially encouraged by the results on the more stringent measures of efficacy, such as ACR70, low disease activity and clinical remission. We look forward to seeing the full results from our Phase 3 program. AbbVie's longstanding leadership in the treatment of immune-mediated diseases provides an opportunity to build upon our understanding and develop innovative therapies to address unmet patient needs."

Results at week 12 showed that of patients receiving a 15 mg or 30 mg oral, once-daily dose of upadacitinib, 64 percent and 66 percent achieved ACR20, respectively, compared to 36 percent of patients receiving placebo.1 Patients receiving upadacitinib achieved ACR50 responses of 38 percent and 43 percent in the 15 mg and 30 mg groups, respectively, compared to 15 percent of patients receiving placebo. ACR70 responses were achieved by 21 percent and 27 percent of patients in the 15 mg and 30 mg groups, respectively, compared to 6 percent of patients receiving placebo.1 Low disease activity was achieved by 48 percent of patients receiving either dose of upadacitinib, compared to 17 percent of patients receiving placebo.1 Additionally, clinical remission was achieved by 31 percent and 28 percent of patients receiving 15 mg or 30 mg of upadacitinib, respectively, compared to 10 percent receiving placebo.1 All primary and key secondary endpoints achieved p-values of <0.001 versus placebo for both doses.1

Dose

ACR20**

ACR50**

ACR70**

LDA***

Clinical Remission****

upadacitinib 15 mg (n=221)

64%

38%

21%

48%

31%

upadacitinib 30 mg (n=219)

66%

43%

27%

48%

28%

Placebo

(n=221)

36%

15%

6%

17%

10%

*All primary and key secondary endpoints achieved p-values of <0.001 vs. placebo for both doses. Not all ranked secondary endpoints shown.

**ACR20/50/70 is defined as American College of Rheumatology 20 percent/50 percent/70 percent improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant.

***LDA was defined by a clinical response Disease Activity Score with 28 joint counts (C-reactive protein) (DAS28 [CRP]) less than or equal to 3.2.

****Clinical remission was based on DAS28 (CRP) response rate less than 2.6.

In this study, the safety profile was consistent with that observed in the upadacitinib Phase 2 clinical trials.1,2,3 No new safety signals were detected.1 Serious adverse events were 4 percent and 3 percent in the 15 mg and 30 mg dose arms, respectively, compared to 2 percent in placebo.1 No deaths were reported.1

"Achieving the target of low disease activity in nearly half of the patients by 12 weeks and doing so at both high and low dose levels is encouraging," said Prof. Gerd Burmester, professor of medicine, Department of Rheumatology and Clinical Immunology, Charité Berlin. "Current treatment recommendations recognize the importance of this clinical target for patients, as achieving low disease activity has remained an unmet need in rheumatoid arthritis."

AbbVie is continuing to evaluate the potential of upadacitinib across several immune-mediated conditions. Phase 3 trials of upadacitinib in psoriatic arthritis are ongoing, and it is also being investigated to treat Crohn's disease, ulcerative colitis and atopic dermatitis.6,7,8,9,10



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