NeuroSpeak & ResearchSpeak: effectiveness and safety of immunosuppressants

Long-term immunosuppression the new marketing battleground to differentiate DMTs. #NeuroSpeak #ResearchSpeak #MSBlog

"As promised a PDF of my slides from one of my ECTRIMS teaching courses on immunosuppressants. Immunosuppression, in particular long-term immunosuppression, was a hot topic at ECTRIMS for several reasons. The main driver, however, is that this will almost certainly become the next marketing battleground to differentiate DMTs from each other. One issue that came up was whether or not boosting your immune response to varicella-zoster virus with a vaccine would reduce your risk of getting shingles or zoster. Until we have definitive data we won't know. The study below of a new component VZV vaccine from GSK is very reassuring; it shows much better protection than the current live VZV vaccine. I would therefore urge all of the MS pharma companies to partner with GSK to do a large study to see if by boosting VZV immunity, in people who are VZV-seropositive, prior to starting an immunosuppressive reduces their risk of getting shingles or zoster. Please note that under current NHS vaccine guidelines we can't do this routinely. The only people we vaccinate with the current VZV vaccine (live attenuated vaccine) prior to starting an immunosuppressive therapy are those who are VZV-seronegative." 



Cunningham et al. Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older. N Engl J Med. 2016 Sep 15;375(11):1019-32. 

Background: A trial involving adults 50 years of age or older (ZOE-50) showed that the herpes zoster subunit vaccine (HZ/su) containing recombinant varicella-zoster virus glycoprotein E and the AS01B adjuvant system was associated with a risk of herpes zoster that was 97.2% lower than that associated with placebo. A second trial was performed concurrently at the same sites and examined the safety and efficacy of HZ/su in adults 70 years of age or older (ZOE-70). 

Methods: This randomized, placebo-controlled, phase 3 trial was conducted in 18 countries and involved adults 70 years of age or older. Participants received two doses of HZ/su or placebo (assigned in a 1:1 ratio) administered intramuscularly 2 months apart. Vaccine efficacy against herpes zoster and postherpetic neuralgia was assessed in participants from ZOE-70 and in participants pooled from ZOE-70 and ZOE-50. 

Results: In ZOE-70, 13,900 participants who could be evaluated (mean age, 75.6 years) received either HZ/su (6950 participants) or placebo (6950 participants). During a mean follow-up period of 3.7 years, herpes zoster occurred in 23 HZ/su recipients and in 223 placebo recipients (0.9 vs. 9.2 per 1000 person-years). Vaccine efficacy against herpes zoster was 89.8% (95% confidence interval [CI], 84.2 to 93.7; P<0.001) and was similar in participants 70 to 79 years of age (90.0%) and participants 80 years of age or older (89.1%). In pooled analyses of data from participants 70 years of age or older in ZOE-50 and ZOE-70 (16,596 participants), vaccine efficacy against herpes zoster was 91.3% (95% CI, 86.8 to 94.5; P<0.001), and vaccine efficacy against postherpetic neuralgia was 88.8% (95% CI, 68.7 to 97.1; P<0.001). Solicited reports of injection-site and systemic reactions within 7 days after injection were more frequent among HZ/su recipients than among placebo recipients (79.0% vs. 29.5%). Serious adverse events, potential immune-mediated diseases, and deaths occurred with similar frequencies in the two study groups. 

Conclusions: In our trial, HZ/su was found to reduce the risks of herpes zoster and postherpetic neuralgia among adults 70 years of age or older. (Funded by GlaxoSmithKline Biologicals; ZOE-50 and ZOE-70 ClinicalTrials.gov numbers, NCT01165177 and NCT01165229.).

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