Upadacitinib Monotherapy Yields Positive Results in Phase 3 Rheumatoid Arthritis Study

Both doses of the oral janus kinase 1 (JAK1) selective inhibitor upadacitinib (15 mg and 30 mg) met the primary endpoints of a 50% improvement in American College of Rheumatology criteria (ACR50) at 12 weeks and clinical remission at 24 weeks compared with methotrexate in adult patients with moderate to severe rheumatoid arthritis (RA).

The SELECT-EARLY study (ClinialTrials.gov Identifier: NCT02706873) is an ongoing clinical trial evaluating upadacitinib as monotherapy for adult patients with moderate to severe RA who are methotrexate-naive.

Compared with methotrexate, a significantly higher percentage of patients receiving upadacitinib in both doses achieved superior responses at 12 and 24 weeks. At 12 weeks, 52% of patients receiving 15 mg of upadacitinib and 56% of patients receiving 30 mg upadacitinib achieved ACR50, compared with 28% of patients receiving methotrexate.

In addition, at 24 weeks, clinical remission defined by the Disease Activity Score of 28 joints was achieved by 48% of patients receiving 15 mg of upadacitinib and 50% of patients achieving 30 mg upadacitinib, compared with 18% of patients receiving methotrexate.

At 24 weeks, low disease activity was achieved by 60% of patients in the 15 mg group and 65% of patients in the 30 mg group. Both doses significantly inhibited radiographic progression as measured by the change in modified total Sharp score compared with methotrexate.

The researchers noted that the safety profile of upadacitinib was consistent with results reported in previous clinical trials.

“It is very encouraging that approximately half of patients achieved the desired clinical target of remission in 6 months with upadacitinib monotherapy at either dose. Outcomes from this trial address the need for additional monotherapy options early in the disease,” stated Ronald van Vollenhoven, MD, PhD, director of the Amsterdam Rheumatology and Immunology Center ARC and professor of rheumatology, University of Amsterdam and Free University. “Results suggest upadacitinib as a monotherapy has the potential to control rheumatoid arthritis and reduce the risk of permanent bone and joint damage for methotrexate-naive patients.”

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Reference

Upadacitinib Monotherapy Meets All Primary and Ranked Secondary Endpoints Versus Methotrexate in a Phase 3 Study in Rheumatoid Arthritis [press release]. North Chicago, Illinois: AbbVie Inc. https://news.abbvie.com/alert-topics/immunology/upadacitinib-monotherapy-meets-all-primary-and-ranked-secondary-endpoints-versus-methotrexate-in-phase-3-study-in-rheumatoid-arthritis.htm. Published June 5, 2018. Accessed June 7, 2018.