NASHVILLE, Tenn. -- Treatment with the humanized anti-CD20 monoclonal antibody ocrelizumab was associated with reduced vaccine response in patients with multiple sclerosis (MS) in a study reported here.
In just over 100 patients, those on ocrelizumab (OCR) were roughly half as likely to have a positive response to a tetanus vaccine at 8 weeks compared with those on no disease-modifying therapy or interferon-beta, according to data presented at the annual meeting of the Consortium of Multiple Sclerosis Centers (CMSC).
Action Points
- Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
Several previous studies have also shown decreased responses to routine vaccinations in patients on various disease-modifying treatments, but this study is the first to examine responses to OCR in MS patients, the authors noted.
Compared with patients who were on no disease-modifying therapies or those on interferon-beta (the control group), patients treated with the monoclonal antibody had decreased humoral response to several vaccines.
"Vaccine response was less than normal, but there was still a response," said CMSC president Michael Racke, MD, of Ohio State University Medical Center in Columbus, who was not involved with the study.
He told 番茄社区 that it is probably a good idea to give routine vaccinations several months before starting patients on biologic medications, if possible. "Vaccinations against infections are an important part of the management of patients with multiple sclerosis."
The randomized, open-label study was conducted to assess whether patients with relapsing MS treated with ocrelizumab raise adequate humoral responses to selected vaccines.
A total of 102 patients were randomized 2:1 into group A (n = 68), receiving a single dose of ocrelizumab 600 mg, or the control group B (n = 34), on no disease-modifying therapy or interferon-beta.
All patients received a tetanus toxoid-containing vaccine, keyhole limpet hemocyanin, and a 23-valent pneumococcal polysaccharide vaccine (23-PPV).
At randomization, group A was subdivided into groups A1 (n = 33), receiving pneumococcal booster vaccine (13-PCV) 4 weeks after 23-PPV, and A2 (n = 35), receiving seasonal influenza vaccine. Group B vaccinations were the same as for group A2. Vaccinations in group A started 12 weeks after OCR treatment start, and in group B, on day 1.
Among the main findings:
- The rate of positive response to tetanus vaccine at 8 weeks was 23.9% in group A (OCR) versus 54.5% in group B (control)
- Positive response to ≥5 serotypes in 23-PPV at 4 weeks was 71.6% in group A (OCR) and 100% in group B (control)
- In group A1 (OCR), the booster vaccine (13-PCV) did not enhance the response to 12 serotypes in common with 23-PPV
- The humoral response to the neoantigen keyhole limpet hemocyanin was decreased in group A (OCR) compared with group B (control) at all time points measured
Seroprotective titers at 4 weeks against five influenza strains (season 2015/2016 and 2016/2017) ranged from 55.6% to 80.0% in group A2 (OCR) and 75.0% to 97.0% in group B (control).
"As expected, ocrelizumab attenuated the humoral response to the studied vaccines," the researchers concluded.
Disclosures
No funding source was noted for the study.
Several of the co-authors were employees of Hoffmann-La Roche. Others reported financial relationships with that company, as well as with Pfizer, Eli Lilly, and others.