Author Topic: NEJM's article on Ocrevus/MS one of top 10 articles in 2017  (Read 115 times)

0 Members and 0 Guests are viewing this topic.

Offline agate

  • Administrator
  • *****
  • Posts: 9664
  • MS diagnosed 1980
  • Location: Pacific Northwest
NEJM's article on Ocrevus/MS one of top 10 articles in 2017
« on: December 26, 2017, 03:47:09 pm »
The New England Journal of Medicine Neurology's article  (January 19, 2017) on Ocrevus for PPMS is one of the 10 articles of 2017 that the journal considers most significant. This is a review of the article as it appeared in NEJM Neurology on January 27, 2017:

January 27, 2017

Positive Clinical Trial Results for Ocrelizumab in Primary Progressive Multiple Sclerosis

Robert T. Naismith, MD reviewing Montalban X et al. N Engl J Med 2017 Jan 19.

This B-cell depleting therapy reduced worsening disability by 24%.

Effective treatments for primary progressive multiple sclerosis (PPMS) have remained a major unmet need. A phase II study of rituximab in PPMS was overall negative, but subgroup analyses suggested possible benefit in younger and less disabled patients. Similar to rituximab, the investigational drug ocrelizumab depletes B cells via binding by CD20. For this multicenter, randomized, double-blind, placebo-controlled, manufacturer-sponsored phase 3 study, investigators recruited 732 patients with PPMS (age range, 18–55; Expanded Disability Status Scale score 3.0– 6.5 [i.e., mild disability through walker dependent]; disease duration <15 years) who met diagnostic criteria plus the presence of abnormal cerebrospinal fluid. Ocrelizumab or placebo was administered as two 300-mg doses separated by 2 weeks, repeated every 6 months.

Disability worsening confirmed at 3 months (the primary outcome) occurred for 33% on ocrelizumab versus 39% on placebo, a 24% relative risk reduction. The 25-foot timed walk worsened from baseline by 39% on treatment versus 55% on placebo. Ocrelizumab also had favorable effects on T2 lesion volume and change in brain volume. Mild infusion reactions occurred in 40% on ocrelizumab and led to discontinuation in 0.4%. Common infections were slightly increased with ocrelizumab. Neoplasms were identified in 2.3% on ocrelizumab versus 0.8% on placebo.


The MS field welcomes favorable study results for PPMS. Ocrelizumab is reasonably well tolerated, and the infrequent dosing is convenient. One third of patients still progressed while taking ocrelizumab, so clinicians should balance optimism with expectations when discussing this treatment with patients. Patients who are older than 55, wheelchair bound, and with disease duration >15 years were not studied; benefits in that population remain unknown. To assess the risk for neoplasms and infectious complications, long-term evaluation of data from clinical trial populations and postmarketing investigations will be needed. For patients with PPMS who fit study criteria, treatment at this time seems recommendable, pending FDA approval.

Dr. Naismith has received honoraria for consulting with Genentech, manufacturer of ocrelizumab.


Disclosures for Robert T. Naismith, MD at time of publication

Consultant / Advisory board   Alkermes; Acorda Therapeutics; Bayer HealthCare; Biogen Idec; EMD Serono; Genzyme Corp./Sanofi; Genentech; Malinckrodt Pharmaceuticals; Pfizer; Novartis
Speaker’s bureau   Acorda Therapeutics; Biogen Idec; Genzyme Corp./Sanofi
Grant / Research support   National Multiple Sclerosis Society; National Institutes of Health
MS Speaks--online for 17 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010. Glatopa (glatiramer acetate 40mg 3 times/week) since 12/16/20.


Related Topics

  Subject / Started by Replies Last post
1 Replies
Last post January 15, 2017, 04:50:34 pm
by agate
0 Replies
Last post April 28, 2017, 10:16:05 am
by agate
0 Replies
Last post April 02, 2020, 10:04:21 pm
by agate
0 Replies
Last post June 05, 2020, 08:09:00 pm
by agate
0 Replies
Last post August 19, 2021, 04:08:40 pm
by agate