Roy Fleischmann, MD: Long-Term Safety, Efficacy of Upadacitinib for Rheumatoid Arthritis Treatment

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Results found all clinical and patient-reported responses were statistically better with upadacitinib plus methotrexate compared with adalimumab plus methotrexate, although both treatments were effective.

In an interview with HCPLive Rheumatology, Roy Fleischmann, MD, clinical professor of medicine at the University of Texas Southwestern Medical Center at Dallas and co-Medical Director of the Metroplex Clinical Research Center in Dallas, discussed the recent results of the SELECT-COMPARE study presented at the European Congress of Rheumatology (EULAR) 2023.1 Patients with rheumatoid arthritis receiving the Janus kinase (JAK) inhibitor, upadacitinib, over a 5-year period reported numerically better clinical responses when compared with patients in the adalimumab cohort. Radiographic progression continued to be similarly low through week 192 in both cohorts.

The SELECT-COMPARE study is an ongoing 10-year study conducted in methotrexate incomplete responders. Patients were either treated with upadacitinib 15 milligrams/day, adalimumab 40 milligrams every other week, or placebo. All patients received background methotrexate. Non-responders to upadacitinib were switched to adalimumab, and non-responders to adalimumab were switched to upadacitinib within the first 6 months.

The initial results of the study showed that upadacitinib plus methotrexate was superior to placebo, which was the primary endpoint. The secondary endpoint was whether upadacitinib was superior to adalimumab, both plus methotrexate, in terms of the American College of Rheumatology 50% response rate (ACR50). The study found that all clinical and patient-reported responses were statistically better with upadacitinib plus methotrexate compared with adalimumab plus methotrexate, although both treatments were effective.

The drug was well tolerated and similar rates of treatment-emergent adverse events (TEAEs), serious TEAEs, and AEs leading to discontinuation were similar across treatment arms.

The team plans to continue monitoring the efficacy and safety of the treatments. The study size is relatively small compared to the ORAL Surveillance study, so the long-term risks, such as major adverse cardiac events (MACE) or venous thromboembolism (VTE), have not been fully explored.

“The SELECT-COMPARE study provides solid and consistent data over multiple years, demonstrating the efficacy and safety of upadacitinib compared to adalimumab in methotrexate incomplete responders,” Fleischmann concluded. “The study emphasizes the potential for patients to respond to the alternative treatment if one option fails. The findings support the use of upadacitinib as a preferred choice.”

This transcript was edited for clarity.

Disclosure: Fleischmann is a consultant for AbbVie, Amgen, Boehringer-Ingelheim, Bristol-Myers Squibb, Eli Lilly, Galapagos, Galvani, Gilead, GSK, Janssen, Novartis, Pfizer, and UCB.

References

R M Fleischmann, J Swierkot, S Penn, P Durez, et al. Long-Term Safety and Efficacy of Upadacitinib or Adalimumab in Patients With Rheumatoid Arthritis: 5-Year Data From the SELECT-COMPARE Study. Paper presented at: European Congress of Rheumatology (EULAR) 2023. Milan, Italy. May 31 – June 3, 2023.

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