The risk of disease reactivation rises in adults with multiple sclerosis who discontinue natalizumab treatment after 24 doses, according to findings from the prospective, multicenter, observational TY-STOP Study.
In an intent-to-treat analysis, disease activity was significantly lower among 43 patients who continued natalizumab treatment, compared with 81 who had interrupted treatment (odds ratios, 0.33 for clinical activity and 0.35 for radiologic activity). In an as-treated analysis, clinical disease activity was more than three times higher in 16 patients who switched treatments (OR, 3.28), and more than four times higher in natalizumab quitters (OR, 4.40), compared with 35 patients who continued on natalizumab. Dr. Marinella Clerico of the University of Turin, San Luigi Gonzaga University Hospital, Orbassano, Italy, and her colleagues reported the findings online June 30 in JAMA Neurology.
One patient who discontinued treatment developed progressive multifocal leukoencephalopathy (PML) during the observation period, but recovered completely (JAMA Neurol. 2014 [doi:10.1001/jamaneurol.2014.1200]).
Continuing natalizumab seems to be the most efficacious therapeutic strategy in those who have already received 24 doses and who must – according to a "meticulous risk management plan" implemented by the European Medicines Agency in the wake of increased incidence of PML among natalizumab users – renew consent to continue treatment after 24 doses. However, given the risk of PML, the decision to continue treatment should take into account the risk of disease reactivation associated with discontinuation as well as the risk of PML with continuation, and treatment should be continued, along with meticulous monitoring for PML, in all patients in whom risk is not considered too high, they concluded.
Dr. Clerico reported receiving travel grants from Merck Serono and Biogen Idec. Other authors also made financial disclosures, the details of which are available with the full text of the article at jamaneurology.com.