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Abbvie (NYSE: ABBV) - RINVOQ[TM] (upadacitinib) Meets Primary and All Ranked Secondary Endpoints in Phase 3 Study in Psoriatic Arthritis -- 31/10/2019.

NORTH CHICAGO, III., Oct. 31, 2019 /PRNewswire/--AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced positive top-line data from the SELECT-PsA 2 Phase 3 study. In this study, both doses of RINVOQ[TM] (upadacitinib; 15 mg and 30 mg, once daily) met the primary endpoint of ACR20 response at week 12 versus placebo in adult patients with active psoriatic arthritis who have responded inadequately to one or more biologic disease modifying anti-rheumatic drugs (bDMARDs). In addition, patients on both doses of RINVOQ achieved significantly greater responses compared to placebo for all ranked secondary endpoints. SELECT-PsA 2 is the first study evaluating the efficacy and safety of RINVOQ in adult patients with active psoriatic arthritis.1 RINVOQ, a selective and reversible JAK inhibitor discovered and developed by AbbVie, is being studied as a once-daily therapy in psoriatic arthritis and multiple immune-mediated diseases.

"Too many people living with psoriatic arthritis still fail to achieve their treatment goals, underscoring a clear medical need for additional therapeutic options," said Michael Severino, M.D., vice chairman and president, AbbVie. "We are pleased with these data, which show the potential of RINVOQ to improve outcomes for people with psoriatic arthritis across a variety of symptoms. Data from this Phase 3 study will support regulatory submissions for RINVOQ in psoriatic arthritis."

Results show that at week 12, 57/64 percent of patients receiving 15/30 mg of RINVOQ achieved ACR20, respectively, compared to 24 percent in the placebo group (p<0.0001). Additionally, ACR50 was achieved by 32/38 percent of patients receiving 15/30 mg of RINVOQ, respectively, compared to 5 percent on placebo at week 12 (p<0.0001). 9/17 percent of patients achieved ACR70 in the 15/30 mg RINVOQ groups, respectively, compared to 0.5 percent in the placebo group at week 12 (p<0.0001). Patients receiving RINVOQ also had greater improvements in physical function at week 12, as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI). RINVOQ showed improvement in skin symptoms at week 16, with 52/57 percent of patients receiving 15/30 mg of RINVOQ achieving a 75 percent improvement in the Psoriasis Area Severity Index (PASI 75), respectively, compared to 16 percent on placebo (p<0.0001). 25/29 percent of 15/30 mg RINVOQ-treated patients achieved minimal disease activity (MDA) at week 24 (p<0.0001), respectively, compared to 3 percent in the placebo group.
SELECT-PsA 2 Efficacy Results (1,[dagger])

                        RINVOQ 15 mg  RINVOQ 30 mg  Placebo
                        (n=211)       (n=218)       (n=212)

ACR20 (a) at week 12    57%           64%           24%
ACR50 (a) at week 12    32%           38%            5%
ACR70 (a) at week 12     9%           17%            0.5%
HAQ-DI (b) at week 12   -0.30         -0.41         -0.10
PASI 75 (c) at week 16  52%           57%           16%
MDA (d) at week 24      25%           29%            3%

Primary endpoint was ACR20 at week 12. All reported endpoints achieved
p-values of <0.0001 versus placebo for both doses. Not all ranked
secondary endpoints shown.

A. ACR20/50/70 is defined as at least a 20 percent/50 percent/70
percent reduction from baseline in the number of both tender and
swollen joint counts and equivalent improvement in three or more of the
five remaining American College of Rheumatology core set measures:
patient assessments of pain, global disease activity, physical
function, physician global assessment of disease activity and acute
phase reactant.
B. HAQ-DI is defined as change in baseline in the Health Assessment
Questionnaire Disability Index, which is a is a patient-reported
questionnaire including categories of dressing and grooming, arising,
eating, walking, hygiene, reach, grip and common daily activities. It
asks patients about the amount of difficulty they experience in these
activities as well as the use of aids and/or devices.
C.PASI 75 is defined as a 75 percent improvement in the Psoriasis Area
Severity Index. It was assessed in patients with
[greater than or equal to]3 percent body surface area (BSA) psoriasis
at baseline.
D.MDA is defined as the fulfillment of 5 of 7 outcome measures: TJC
[less than or equal to]1; SJC [less than or equal to]1; PASI
[less than or equal to]1 or BSA-Ps [less than or equal to]3 percent;
Patient's Assessment of Pain NRS [less than or equal to]1.5;
PtGA-Disease Activity NRS [less than or equal to]2.0; HAQ-DI score
[less than or equal to]0.5; and LEI (Leeds Enthesitis Index)
[less than or equal to]1.

In this study, the safety profile of RINVOQ was consistent with that observed in previously reported studies in patients with rheumatoid arthritis, with no new safety risks detected. Through week 24, serious infections occurred in 0.5/2.8 percent of patients in the 15/30 mg RINVOQ groups, respectively, compared to 0.5 percent in the placebo group.1 There was one pulmonary embolism reported in the 15 mg RINVOQ group and none in the 30 mg and placebo groups. There was one non-fatal adjudicated major adverse cardiovascular event (MACE) in the 15 mg RINVOQ group (acute myocardial infarction) and no MACE in the 30 mg and placebo groups. One death was reported in a patient receiving placebo (motor vehicle accident).

Psoriatic arthritis is a heterogeneous systemic inflammatory disease with hallmark manifestations in joints and skin, affecting more than 50 million people worldwide. In psoriatic arthritis, the immune system creates inflammation that can lead to pain, fatigue and stiffness in the joints.

Full results from the SELECT-PsA 2 study will be presented at a future medical meeting and published in a peer-reviewed publication.
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Title Annotation:Media Releases
Publication:US Pharmaceuticals
Article Type:Report
Date:Nov 4, 2019
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