AbbVie Inc.'s upadacitinib met all primary and key secondary goals in a phase 3 trial studying the medication in patients with moderate to severe rheumatoid arthritis who did not adequately respond to treatment with methotrexate, an older medication.
The trial, dubbed Select-Monotherapy, analyzed patients' American College of Rheumatology, or ACR, scores and monitored low disease activity as its main objectives. An ACR score is a measure of change in rheumatoid arthritis symptoms, which include stiffness, swelling and pain in the joints. For example, an ACR score of 20 indicates a 20% improvement in tender and swollen joints, plus three other signs of symptom relief.
Trial participants received methotrexate, 15 milligrams of upadacitinib, or 30 milligrams of upadacitinib. After 14 weeks of treatment, 68% of patients taking the 15-milligram dose demonstrated an ACR score of 20, 42% had shown a score of 50 and 23% had had a score of 70. In addition, 28% of these patients were in clinical remission, meaning signs of the disease were significantly reduced.
ACR scores of 20, 50 and 70 were achieved in 71%, 52% and 33% of the patients treated with 30 milligrams of upadacitinib, respectively, and 41% were in remission. In patients who continued treatment with methotrexate, 41%, 15%, and 3% achieved similar ACR scores, and 8% were in remission.
Low disease activity was reported in 45% and 53% of patients in the 15-milligram and 30-milligram groups, respectively, compared to 19% of patients continuing on methotrexate.
Upadacitinib demonstrated a tolerable safety profile, consistent with other trials of the Select research program, AbbVie said.
Upadacitinib is also being evaluated in the treatment of Crohn's disease, ulcerative colitis, ankylosing spondylitis and atopic dermatitis.
Methotrexate is a commonly used first line of treatment in rheumatoid arthritis patients.
Upadacitinib earlier met its goals in a phase 3 trial studying the drug against a placebo. That trial was called Select-Beyond.