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

AbbVie recently issued the following announcement.

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

NORTH CHICAGO, Ill., April 25, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today 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 ACR20a versus placebo.1 Certain key efficacy endpoints were also achieved versus placebo.1 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.1 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.

SELECT-SUNRISE is a local dose-ranging study in Japanese patients and is part of AbbVie's robust global upadacitinib SELECT clinical trial program, which is evaluating more than 4,000 patients with moderate to severe rheumatoid arthritis.

"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."

Rheumatoid arthritis, which affects an estimated 1 million people in Japan, is a chronic and debilitating disease.16, 17 Despite increasing availability of a range of treatments in Japan, some patients with rheumatoid arthritis still do not achieve clinical remission or tight control of their disease.16

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).1 As early as week one, significantly more patients on upadacitinib achieved ACR20 compared to placebo (31/25/34 percent in the 7.5/15/30 mg upadacitinib groups, respectively, compared to 8 percent in the placebo group, p<0.01/0.05/0.01).1 Additionally, significantly more patients receiving upadacitinib also achieved ACR50a and ACR70a responses compared to placebo.1 Among 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).1

The study also showed that a significantly higher proportion of upadacitinib patients across all doses achieved low disease activityc and clinical remissionb at week 12 compared to patients receiving placebo.1 Low disease activity was achieved by 53/69/72 percent of upadacitinib patients in the 7.5/15/30 mg groups, respectively, compared to 18 percent in the placebo group (p<0.001).1 Clinical remission was achieved by 37/57/50 percent of upadacitinib patients in the 7.5/15/30 mg groups, respectively, compared to 6 percent in the placebo group (p<0.001).1 Patients receiving upadacitinib also had greater improvements in physical function, as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and decreased severity of morning stiffness.1

SELECT-SUNRISE Efficacy Results at Week 12†

Placebo

(n=49)

Upadacitinib

7.5 mg

(n=49)

Upadacitinib

15 mg

(n=49)

Upadacitinib

30 mg

(n=50)

ACR20a

43%

76%

84%

80%

ACR50a

16%

41%

65%

58%

ACR70a

2%

20%

35%

28%

Clinical Remission (DAS28-CRP)b

6%

37%

57%

50%

Low Disease Activity (DAS28-CRP)c

18%

53%

69%

72%

†All week 12 endpoints shown in the table achieved p-values of <0.001 except ACR50/70 responses with 7.5 mg upadacitinib which achieved p-values of <0.01. Not all secondary endpoints shown.

a ACR20/50/70 is defined as American College of Rheumatology 20 percent/50 percent/70 percent improvements in both tender and swollen joint counts, plus 3 of the following: patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant.

b Clinical remission was based on Disease Activity Score with 28 joint counts (C-reactive protein) (DAS28 [CRP]) less than less than 2.6.

c Low disease activity 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.

The safety profile of upadacitinib during the 12-week reporting period was consistent with previously reported results.1-7 No new safety signals were detected.1 Serious adverse events occurred in 2/2/10 percent of the 7.5/15/30 mg upadacitinib groups, respectively, compared to 0 percent in the placebo group.1 Serious infection occurred in 0/2/6 percent of the upadacitinib 7.5/15/30 mg groups, compared to 0 percent in the placebo group.1 There were no major adverse cardiovascular events reported in the trial.1 There were no deaths, no events of pulmonary embolism (PE) or deep vein thrombosis (DVT) reported.1 Across the SELECT rheumatoid arthritis program, including both the placebo-controlled and extension periods, the rate of DVT and PE remains consistent with the background rate for the RA patient population.1-5, 18-20

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https://news.abbvie.com/news/abbvies-upadacitinib-meets-primary-and-key-efficacy-endpoints-in-phase-2b3-rheumatoid-arthritis-study-in-japanese-patients.htm

AbbVie (NYSE:ABBV) is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Labs.

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