Upadacitinib for rheumatoid arthritis
In April 2018, AbbVie (ABBV) positive results for its Phase 3 SELECT-COMPARE trial, which evaluated the safety and efficacy of upadacitinib for adults with moderate-to-severe rheumatoid arthritis. The trial met its primary endpoint of improved ACR20[1.American College of Rheumatology] scores and clinical remission.
In a press release on April 9, 2018, Abbvie reported that “at week 12, 71 percent of patients receiving an oral once-daily dose of upadacitinib 15 mg achieved an ACR20 response, compared with 36 percent of patients receiving placebo.” According to the press release, 29% of patients receiving upadacitinib demonstrated clinical remission, compared with 6% of patients on placebo therapy.
In the trial, 45% and 25% patients on upadacitinib demonstrated improved ACR50 and ACR70 scores, respectively, compared with 15% and 5% patients on placebo therapy. In the rheumatoid arthritis drug market, AbbVie’s upadacitinib would compete with Sanofi (SNY) and Regeneron Pharmaceuticals’ (REGN) Kevzara, Roche’s (RHHBY) Actemra, and Johnson & Johnson’s (JNJ) Simponi and Remicade.
Upadacitinib for atopic dermatitis
In February 2018, AbbVie presented new data from its Phase 2b trial evaluating the safety and efficacy of upadacitinib for the treatment of individuals with atopic dermatitis. At Week 16 in the trial, 74%, 62%, and 39% patients on upadacitinib 30 mg,[1.milligram] 15mg, and 7.5 mg, respectively, demonstrated a mean percentage change in EASI (eczema area and severity index) scores. In January 2018, the FDA granted upadacitinib breakthrough therapy designation for the treatment of adult individuals with moderate-to-severe atopic dermatitis who are eligible for systemic therapy.