ACR Convergence 2020: Study Data for Lupus & Rheumatoid Arthritis

The therapy may also be promising for patients with cutaneous  lupus erythematosus (CLE), for which no specifically targeted therapies have ever been developed. Results from part B of the study, which looked at responses in patients with cutaneous lupus erythematosus, were presented later that day in an abstract session by another collaborator, Victoria Werth, MD, a professor of dermatology at the Hospital of the University of Pennsylvania, Philadelphia. Doses of 50 mg, 150 mg and 450 mg BIIB059 given every four weeks for 16 weeks significantly reduced CLASI-A scores at week 16, with a significantly dose-responsive relationship. At week 16, a higher proportion of patients at the 450 mg dose achieved a seven point or greater reduction in CLASI-A compared with placebo.

Dr. Curtis

Withdrawal of Etanercept or Methotrexate During RA Remission
Jeffrey R. Curtis, MD, MPH, a professor of medicine in the Division of Clinical Immunology and Rheumatology at the University of Alabama at Birmingham, spoke about results from the SEAM-RA trial (Study of Etanercept And Methotrexate in RA), which studied the effects of withdrawing methotrexate or etanercept in patients who had been in remission on a combination therapy.³

Dr. Curtis pointed out that for RA patients in sustained remission on a combination therapy, such as methotrexate combined with a TNF-inhibitor like etanercept, it’s not clear if both these therapies need to be used indefinitely. “For someone in their 40s or 50s, having to stay on both of these medicines for what might be decades is a bit of a daunting prospect,” he noted.

Both ACR and EULAR guidelines recommend considering tapering RA medications for patients in sustained remission. “Probably it’s not realistic to expect people to come off all [RA] therapies, but the idea that someone starting on two drugs, combination therapy, might be able to withdraw one of them—that probably would be quite attractive to many patients, as well as clinicians,” said Dr. Curtis. However, the optimal way to approach this has not been clear.

This is not the first RA trial to study the question of therapy withdrawal in patients in remission. Dr. Curtis noted that one aspect that sets this trial apart is the use of a very stringent definition of remission. Before trial screening, patients had been in remission for six months or more on combination therapy of etanercept and methotrexate. During a 24-week lead in period, participants were evaluated several times for remission status, to make sure that they were still in remission, as assessed by the Simplified Disease Activity Index (SDAI).