Throughout the 5 years of the phase 3 SELECT-EARLY trial, patients treated with upadacitinib 15 mg or 30 mg showed better clinical response than those treated with methotrexate for rheumatoid arthritis (RA), Vibeke Strand, MD, stated during her presentation at the ACR Convergence on November 12.

Dr Strand is an adjunct clinical professor at the Stanford University School of Medicine in Palo Alto, California.

“There were higher rates of several adverse events, including serious infection, herpes zoster, and creatine phosphokinase (CPK) elevation with upadacitinib when compared to methotrexate,” Dr Strand said, “but when used as monotherapy in methotrexate-naïve patients, upadacitinib has better long-term efficacy and a favorable benefit-risk profile.”

The researchers randomly assigned patients 1:1:1 to upadacitinib 15 mg or upadacitinib 30 mg or methotrexate. Of the 775 randomized patients, those receiving upadacitinib consistently demonstrated higher achievement of disease activity targets over 5 years compared with methotrexate.

At week 260, 53% patients on upadacitinib 15mg and 59% on upadacitinib 30mg attained Clinical Disease Activity Index remission compared to 43% patients on methotrexate.

The overall rates of major adverse cardiovascular events, venous thromboembolism, lymphopenia, and malignancy excluding nonmelanoma skin cancer were similar across treatments.

Reference:
Strand V. 0459: Upadacitinib monotherapy versus methotrexate in patients with rheumatoid arthritis: Efficacy and safety through 5 Years in the SELECT-EARLY randomized controlled trial. Presented at: American College of Rheumatology Convergence. November 12, 2023. San Diego.