Immunology

NORTH CHICAGO, Ill., Dec. 10, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced top-line results from the Phase 3b Heads Up study showing that upadacitinib (30 mg, once daily) achieved superiority to dupilumab (300 mg, every other week) for the primary endpoint, the proportion of patients with at least a 75 percent improvement in the Eczema Area Severity Index (EASI 75) at week 16, in adults with moderate to severe atopic dermatitis.¹ Of patients treated with upadacitinib, 71 percent achieved EASI 75 at week 16 compared to 61 percent of dupilumab-treated patients (p=0.006).¹ Upadacitinib also showed superiority compared to dupilumab for all ranked secondary endpoints, including additional measures of skin clearance and itch reduction.¹

NORTH CHICAGO, Ill., Dec. 9, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive results from the Phase 3 induction study, U-ACHIEVE, which showed upadacitinib (45 mg, once daily) met the primary endpoint of clinical remission (per Adapted Mayo Score) at week 8, as well as all ranked secondary endpoints, in adult patients with moderate to severe ulcerative colitis.¹ In the study, 26 percent of patients receiving upadacitinib achieved clinical remission compared to 5 percent of patients receiving placebo (p<0.001).¹ U-ACHIEVE is the first of two Phase 3 induction studies to evaluate the safety and efficacy of upadacitinib in adults with moderate to severe ulcerative colitis.¹

NORTH CHICAGO, Ill., Aug. 25, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that it has submitted an application for a new indication to the U.S. Food and Drug Administration (FDA) for RINVOQ™ (upadacitinib; 15 mg, once daily), a selective and reversible JAK inhibitor, for the treatment of adult patients with active ankylosing spondylitis. AbbVie also submitted an application to the European Medicines Agency (EMA) for RINVOQ earlier this year for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy.

NORTH CHICAGO, Ill., July 28, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced upadacitinib (15 mg and 30 mg, once daily) plus topical corticosteroids (TCS) met the co-primary endpoints and all secondary endpoints in AD Up, the third pivotal Phase 3 study of RINVOQ in atopic dermatitis.¹ AD Up evaluated the efficacy and safety of both doses of upadacitinib therapy versus placebo in adults and adolescents with moderate to severe atopic dermatitis; all treatment groups, including placebo, received concomitant TCS.¹ The co-primary endpoints were at least a 75 percent improvement in the Eczema Area Severity Index (EASI 75) from baseline and a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0/1 (clear or almost clear) at week 16.¹

NORTH CHICAGO, Ill., June 18, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced upadacitinib (15 mg and 30 mg, once daily) monotherapy met the co-primary endpoints of at least a 75 percent improvement in the Eczema Area Severity Index (EASI 75) and a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) of clear or almost clear (0/1) at week 16 in adults and adolescents with moderate to severe atopic dermatitis who are candidates for systemic therapy.¹ Measure Up 1 is the first pivotal Phase 3 study to evaluate the efficacy and safety of RINVOQ for the treatment of moderate to severe atopic dermatitis.

NORTH CHICAGO, Ill., June 12, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new late-breaking Phase 3b head-to-head data showing superior rates of skin clearance for SKYRIZI^® (risankizumab-rzaa) to COSENTYX^® (secukinumab) at week 52.¹ Particularly, 66 percent of psoriasis patients receiving SKYRIZI achieved completely clear skin—100 percent clearance in the Psoriasis Area and Severity Index (PASI 100)—versus 40 percent of patients receiving COSENTYX at week 52 (p<0.001).¹

NORTH CHICAGO, Ill., June 10, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new data from a Phase 2a study of ABBV-3373, an investigational anti-tumor necrosis factor (TNF) Glucocorticoid Receptor Modulator (GRM) steroid antibody drug conjugate (ADC), in adult patients with moderate to severe rheumatoid arthritis.¹ The primary endpoint was the change in Disease Activity Score 28 C-Reactive Protein (DAS28-CRP) from baseline to week 12 and two statistical comparisons were pre-specified.¹ The first compared ABBV-3373 and mean outcome from historical adalimumab data.¹ The second compared ABBV-3373 and combined in-trial and historical adalimumab data.¹ Results of the first comparison show a greater difference in the primary endpoint change in DAS28-CRP from baseline to week 12 for ABBV-3373 (-2.65) as compared to a pre-specified historical adalimumab mean (-2.13) (p=0.022).¹ Results of the second comparison, based on a Bayesian analysis, predicted with a 90 percent probability that ABBV-3373 was associated with a greater improvement on DAS28-CRP from baseline to week 12 than adalimumab based on in-trial data combined with historical data.¹ Additionally, evaluations of serum cortisol levels over 12 weeks indicate that ABBV-3373 showed no systemic glucocorticoid effects.¹

NORTH CHICAGO, Ill., June 6, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new Phase 3 data from the SELECT-CHOICE clinical trial, showing that RINVOQ™ (upadacitinib, 15 mg, once daily) met the primary endpoint of non-inferiority versus ORENCIA^® (abatacept) on change from baseline in Disease Activity Score 28 C-Reactive Protein (DAS28-CRP) at week 12.¹ In addition, RINVOQ met the key secondary endpoints of superiority versus ORENCIA on change from baseline in DAS28-CRP at week 12 and proportion of patients achieving clinical remission at week 12 as measured by DAS28-CRP<2.6.¹ The study evaluated RINVOQ in adult patients with moderate to severe active rheumatoid arthritis and prior inadequate response or intolerance to biologic disease-modifying anti-rheumatic drugs (DMARDs). Full results were presented today at the 2020 Annual European E-Congress of Rheumatology (EULAR).

NORTH CHICAGO, Ill., June 4, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new long-term results showing that once daily upadacitinib continued to improve signs and symptoms in patients with rheumatoid arthritis at 72 and 84 weeks in the SELECT-COMPARE (upadacitinib, 15 mg in combination with methotrexate [MTX]) and SELECT-MONOTHERAPY (upadacitinib, 15 mg and 30 mg) Phase 3 clinical trials, respectively.^1,2 The safety profile of upadacitinib (15 mg and 30 mg) monotherapy or upadacitinib (15 mg) in combination with MTX was consistent with that observed in the previously reported integrated Phase 3 safety analysis in rheumatoid arthritis, with no new safety risks detected.^1-5