Oral methylprednisolone found noninferior to IV steroids for MS relapse

This study robustly addressed a question of high importance in clinical practice and with important implications for patients. Moreover, the time window chosen for this study, of only 14 days between onset of symptoms and treatment, compared with the longer time periods of previous studies, is more suitable to establish the role of route administration in relapse recovery, allowing exploration of the effects of steroids on acute inflammation. Windows longer than 14 days reduce the potential beneficial effects on inflammation (the period of enhancement in a new lesion is about 4 weeks) and increase inter-patient variability.

The major limitation of Dr. Le Page and colleagues’ study was the absence of MRI data to support the clinical findings, considering the established modest intra-rater and inter-rater concordance. The use of the same assessor for each patient throughout the study significantly reduced but did not eliminate this bias.

Even with some limitations, the study by Dr. Le Page and colleagues is a milestone in the history of treatment for multiple sclerosis and will lead to a change in clinical practice with relevant advantages for both patients and the community, with potential applications in many other disorders when short courses of high-dose steroids are needed. Despite accumulating evidence for the equal effects of intravenous and oral high-dose steroids, oral administration has not entered clinical practice, except in a few countries, and is mostly not considered as a treatment scheme for relapses in clinical trials, perhaps because in most countries formulations of high-dose steroids for oral administration are not available. In the study by Dr. Le Page and colleagues, 10 tablets were needed to reach the cumulative daily dosage of 1,000 mg of methylprednisolone. More efforts are needed to obtain adequate oral formulations, and we hope that the clear results of this clinical trial will promote actions to address this issue.

Dr. Giancarlo Comi and Dr. Marta Radaelli are with the department of neurology at Vita-Salute San Raffaele University and Hospital San Raffaele in Milan. Dr. Comi declared having received consulting fees from Novartis, Teva, Sanofi, Genzyme, Merck Serono, Biogen, Bayer, Serono Symposia International Foundation, Roche, Almirall, Chugai, and Receptos. Dr. Radaelli declared no competing interests. These comments were taken from their accompanying editorial(Lancet 2015;386[9997];937-9).