Immunology

NORTH CHICAGO, Ill., Nov. 12, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced positive data from the Phase 2/3 SELECT-AXIS 1 trial in which twice as many adult patients with active ankylosing spondylitis (AS) treated with RINVOQ™ (upadacitinib; 15 mg, once-daily) achieved the primary endpoint of Assessment of SpondyloArthritis International Society (ASAS) 40 response at week 14 versus placebo (52 percent vs. 26 percent; p<0.001).¹ SELECT-AXIS 1 is the first trial to evaluate the efficacy and safety of RINVOQ in adult patients with active AS who are naïve to biologic disease-modifying antirheumatic drugs (bDMARDs) and had inadequate response or intolerance to nonsteroidal anti-inflammatory drugs (NSAIDs).¹

NORTH CHICAGO, Ill., Nov. 4, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced it will present data from multiple studies of RINVOQ™ (upadacitinib), HUMIRA® (adalimumab) and SKYRIZI™ (risankizumab) at the 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP) Annual Meeting, November 8-13, in Atlanta. A total of 38 abstracts will be presented across multiple rheumatic conditions, including rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA).

NORTH CHICAGO, Ill., 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™ (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).¹ In addition, patients on both doses of RINVOQ achieved significantly greater responses compared to placebo for all ranked secondary endpoints.¹ 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^1,3-10

NORTH CHICAGO, Ill., Oct. 29, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the launch of Let Me Be Clear, an empowerment platform for people living with psoriasis. The initiative, which launches on World Psoriasis Day, invites people living with psoriasis to share their story, discuss what freedom from psoriasis would mean to them and access tools to have clear and informed conversations with their physicians.

NORTH CHICAGO, Ill., Oct. 18, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for RINVOQ™ (upadacitinib), a once-daily selective and reversible JAK inhibitor, for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). The positive opinion is for use of upadacitinib as monotherapy or in combination with methotrexate.

NORTH CHICAGO, Ill., Oct. 9, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that it will present new results evaluating the safety and efficacy of SKYRIZI™ (risankizumab) at 2.5 years in adult patients with moderate to severe plaque psoriasis, as well as additional data on HUMIRA^® (adalimumab) and the investigational JAK inhibitor upadacitinib, at the 28^th European Academy of Dermatology and Venereology (EADV) Congress, October 9-13, in Madrid.

NORTH CHICAGO, Ill., Aug. 16, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved RINVOQ^™ (upadacitinib), a 15 mg, once-daily oral Janus kinase (JAK) inhibitor, for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX-IR).¹ RINVOQ is expected to be available in the U.S. in late August 2019.

NORTH CHICAGO, Ill., June 12, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new results from the Phase 3 clinical trials SELECT-EARLY and SELECT-COMPARE showing that patients receiving upadacitinib once-daily (15 mg or 30 mg, SELECT-EARLY; 15 mg plus methotrexate (MTX), SELECT-COMPARE) through 48 weeks continue to demonstrate improved signs and symptoms of rheumatoid arthritis, as measured by ACR20/50, and clinical remission based on Disease Activity Score 28 C-Reactive Protein (DAS28-CRP)<2.6.^1,2 The studies evaluate upadacitinib, an investigational, once-daily JAK1-selective inhibitor, in patients with moderately to severely active rheumatoid arthritis.^1,2 Additionally, data from an integrated safety analysis across five Phase 3 SELECT clinical trials show that treatment with upadacitinib in patients with moderately to severely active rheumatoid arthritis demonstrates a consistent safety profile.³

NORTH CHICAGO, Ill., June 11, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new results showing a significant number of patients treated with SKYRIZI™ (risankizumab) experienced complete skin clearance at week 94.¹ In the study, at week 28 patients who achieved a static Physician Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) were re-randomized to continue treatment with SKYRIZI or withdrawal.¹ After 94 weeks of continuous treatment with SKYRIZI, 73 percent and 72 percent of these patients achieved a sPGA score of clear (sPGA 0) and a 100 percent improvement in the Psoriasis Area and Severity Index (PASI 100), respectively, compared to 2 percent of patients re-randomized to withdrawal (p<0.001).¹ These two-year results (up to 104 weeks) from the Phase 3 IMMhance study, evaluating the efficacy and safety of SKYRIZI in adult patients with moderate to severe psoriasis, will be presented today at the 24th World Congress of Dermatology (WCD) in Milan.