Effect of ocrelizumab on vaccine responses in patients with multiple sclerosis

ObjectiveThe phase IIIb A Study to Evaluate the Effects of Ocrelizumab on Immune Responses in Participants With Relapsing Forms of Multiple Sclerosis (VELOCE) study (NCT02545868) assessed responses to selected vaccines in ocrelizumab (OCR)-treated patients with relapsing multiple sclerosis.MethodsPatients were randomized 2:1 into the OCR group (n = 68; OCR 600 mg) or control group (n = 34; interferon beta or no disease-modifying therapy). All received tetanus toxoid (TT)-containing vaccine, Pneumovax (23-valent pneumococcal polysaccharide vaccine [23-PPV]), and keyhole limpet hemocyanin (KLH). The OCR group was subdivided into OCR1 (n = 33) and OCR2 (n = 35) at randomization. The OCR1 group received Prevnar (13-valent conjugate pneumococcal vaccine) 4 weeks after 23-PPV; the OCR2 and control groups received influenza vaccine. Vaccinations started 12 weeks after OCR initiation (OCR group) or on day 1 (control group).ResultsPositive response rate to TT vaccine at 8 weeks was 23.9% in the OCR vs 54.5% in the control group. Positive response rate to ≥5 serotypes in 23-PPV at 4 weeks was 71.6% in the OCR and 100% in the control group. Prevnar did not enhance response to pneumococcal serotypes in common with Pneumovax. Humoral response to KLH was decreased in the OCR vs control group. Seroprotection rates at 4 weeks against 5 influenza strains ranged from 55.6% to 80.0% in the OCR2 group and 75.0% to 97.0% in the control group.ConclusionPeripherally B-cell–depleted OCR recipients mounted attenuated humoral responses to clinically relevant vaccines and the neoantigen KLH, suggesting that use of standard nonlive vaccines while on OCR treatment remains a consideration. For seasonal influenza vaccines, it is recommended to vaccinate patients on OCR because a potentially protective humoral response, even if attenuated, can be expected.Classification of evidenceThis study provides Class II evidence confirming that the humoral response to nonlive vaccines in patients with relapsing multiple sclerosis after OCR treatment is attenuated compared with untreated or interferon beta–treated patients, but they can still be expected to be protective.Clinicaltrials.gov identifierNCT02545868.

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Association of shared decision making with inpatient satisfaction: a cross-sectional study

BMC Medical Informatics and Decision Making ◽

10.1186/s12911-021-01385-1 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Huiwen Luo ◽

Guohua Liu ◽

Jing Lu ◽

Di Xue

Keyword(s):

Patient Satisfaction ◽

Inpatient Care ◽

Response Rate ◽

Positive Response ◽

Physician Services ◽

Cross Sectional ◽

Medical Expenses ◽

Tertiary Hospitals ◽

Positive Response Rate ◽

High Level

Abstract Background We assessed inpatient perceived shared decision making (SDM) and tested the association of SDM with inpatient satisfaction in public tertiary hospitals in Shanghai, China. Methods A cross-sectional survey of 2585 inpatients in 47 public tertiary hospitals in Shanghai in July and August 2018 was conducted. We assessed overall SDM and 4 aspects of SDM and tested the factors influencing SDM and the association of SDM with patient satisfaction (patient satisfaction with physician services, medical expenses, outcomes and overall inpatient care), by adopting linear or two-level regression models. Results The positive response rate (PRR) and high positive response rate (HPRR) to overall SDM among the inpatients of public tertiary hospitals in Shanghai were relatively high (95.30% and 87.86%, respectively), while the HPRR to “My physician informed me of different treatment alternatives” was relatively low (80.09%). In addition, the inpatients who underwent surgery during admission had higher HPRRs and adjusted HPRRs to overall SDM than those who did not undergo surgery. The study showed that the adjusted high satisfaction rates (HSRs) with physician services, medical expenses, outcomes and overall inpatient care among the inpatients with high level of overall SDM were higher (96.50%, 68.44%, 89.50% and 92.60%) than those among the inpatients without a high level of overall SDM (71.77%, 35.19%, 57.30% and 67.49%). The greatest differences in the adjusted HSRs between the inpatients with and without a high level of SDM were found in inpatient satisfaction with medical expenses and informed consent in SDM. Moreover, 46.22% of the variances in the HSRs with overall inpatient care across the hospitals were attributed to the hospital type (general hospitals vs. specialty hospitals). Conclusions Inpatient PRRs and HPRRs to SDM in public tertiary hospitals in Shanghai are relatively high overall but lower to information regarding alternatives. SDM can be affected by the SDM preference of both the patients and physicians and medical condition. Patient satisfaction can be improved through better SDM and should be committed at the hospital level.

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Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis

New England Journal of Medicine ◽

10.1056/nejmoa1601277 ◽

2017 ◽

Vol 376 (3) ◽

pp. 221-234 ◽

Cited By ~ 596

Author(s):

Stephen L. Hauser ◽

Amit Bar-Or ◽

Giancarlo Comi ◽

Gavin Giovannoni ◽

Hans-Peter Hartung ◽

...

Keyword(s):

Multiple Sclerosis ◽

Interferon Beta ◽

Relapsing Multiple Sclerosis

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Patient-rated suitability of a novel electronic device for self-injection of subcutaneous interferon beta-1a in relapsing multiple sclerosis: an international, single-arm, multicentre, Phase IIIb study

BMC Neurology ◽

10.1186/1471-2377-10-28 ◽

2010 ◽

Vol 10 (1) ◽

Cited By ~ 27

Author(s):

Virginia Devonshire ◽

Txomin Arbizu ◽

Björn Borre ◽

Michael Lang ◽

Alessandra Lugaresi ◽

...

Keyword(s):

Multiple Sclerosis ◽

Interferon Beta ◽

Electronic Device ◽

Multicentre Phase ◽

Phase Iiib ◽

Relapsing Multiple Sclerosis

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In VitroAssessment of the Biologic Activity of Interferon Beta Formulations used for the Treatment of Relapsing Multiple Sclerosis

Journal of Immunoassay and Immunochemistry ◽

10.1080/15321819.2013.848815 ◽

2014 ◽

Vol 35 (3) ◽

pp. 288-299 ◽

Cited By ~ 5

Author(s):

Carolina Scagnolari ◽

Carla Selvaggi ◽

Emilia Di Biase ◽

Maurizio Fraulo ◽

Fernando Dangond ◽

...

Keyword(s):

Multiple Sclerosis ◽

Interferon Beta ◽

Biologic Activity ◽

Relapsing Multiple Sclerosis

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Waning Humoral Response 3 to 6 Months after Vaccination with the SARS-COV-2 BNT162b2 mRNA Vaccine in Dialysis Patients

Journal of Clinical Medicine ◽

10.3390/jcm11010064 ◽

2021 ◽

Vol 11 (1) ◽

pp. 64

Author(s):

Noa Berar-Yanay ◽

Sarit Freiman ◽

Maʹanit Shapira ◽

Amer Saffoury ◽

Ameer Elemy ◽

...

Keyword(s):

Response Rate ◽

Vaccine Dose ◽

Humoral Response ◽

Albumin Level ◽

High Response Rate ◽

Control Group ◽

Dialysis Patients ◽

Serious Adverse Events ◽

Antibody Levels

Background and objectives: The short-term reported antibody response to SARS-COV-2 vaccination in dialysis patients is high, with a seroconversion response rate up to 97%. Data on the long-term durability of this response are scarce. Our objective was to characterize the long-term anti-spike antibody level in dialysis patients. Design, setting, participants, and measurements: In an observational study, we measured SARS-COV-2 anti-spike antibody levels in dialysis patients who completed 2 doses of the BNT162b2 mRNA SAR S-COV-2 vaccine at 1, 3 and 6 months after the second vaccine dose. We compared the response to dialysis patients who were infected with COVD-19 and to a control group of healthcare-employees. Results: One hundred and forty-two dialysis patients who had been vaccinated (ages 64 ± 11.9 years, 61% male), 33 dialysis patients who had COVID-19 infection (ages 54 ± 14.3 years, 55% male) and 104 individuals in the control group (ages 50 ± 12.2 years, 44% male) were included. The response rate in the vaccinated dialysis patients was 94%, 78% and 73% at 1, 3 and 6 months after the second vaccine dose. In the COVID-19 infected dialysis group and in the control group, the response rate remained at 100% over 6 months. The percentage of change in antibody levels between one and 6 months was −66% in the vaccinated dialysis group, −28% in the control group (p < 0.001) and +48% in dialysis patients who had been infected with COVID-19 (p < 0.001). A non-responder status at 6 months was associated with a lower albumin level. No serious adverse events following vaccination were reported. In conclusion: the initially high response rate to the BNT162b2 vaccine in dialysis patients decreases rapidly. Our results indicate that an early booster (3rd) dose, at three months after the second dose, may be advised for this population to preserve the humoral immunity.

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Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (RADIANCE): a multicentre, randomised, 24-month, phase 3 trial

The Lancet Neurology ◽

10.1016/s1474-4422(19)30238-8 ◽

2019 ◽

Vol 18 (11) ◽

pp. 1021-1033 ◽

Cited By ~ 35

Author(s):

Jeffrey A Cohen ◽

Giancarlo Comi ◽

Krzysztof W Selmaj ◽

Amit Bar-Or ◽

Douglas L Arnold ◽

...

Keyword(s):

Multiple Sclerosis ◽

Interferon Beta ◽

Phase 3 ◽

Safety And Efficacy ◽

Relapsing Multiple Sclerosis

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Patients transitioning from non-pegylated to pegylated interferon beta-1a have a low risk of new flu-like symptoms: ALLOW phase 3b trial results

Multiple Sclerosis Journal - Experimental Translational and Clinical ◽

10.1177/2055217318822148 ◽

2019 ◽

Vol 5 (1) ◽

pp. 205521731882214 ◽

Cited By ~ 1

Author(s):

Robert T Naismith ◽

Barry Hendin ◽

Sibyl Wray ◽

DeRen Huang ◽

Fiorenza Gaudenzi ◽

...

Keyword(s):

Multiple Sclerosis ◽

Interferon Beta ◽

Pegylated Interferon ◽

Symptom Duration ◽

Open Label ◽

Open Label Study ◽

Management Guidance ◽

Cumulative Duration ◽

Multiple Sclerosis Patients ◽

Relapsing Multiple Sclerosis

Background Flu-like symptoms are common adverse events associated with interferon beta relapsing multiple sclerosis therapies. Objectives To evaluate the incidence and severity of flu-like symptoms after transitioning from non-pegylated interferons to peginterferon beta-1a and assess flu-like symptom mitigation using naproxen. Methods ALLOW was a phase 3b open-label study in relapsing multiple sclerosis patients. Patients had received non-pegylated interferon for 4 or more months immediately before beginning a 4-week screening period. At baseline, patients switched to peginterferon beta-1a and were randomly assigned (1:1) to continue their current flu-like symptoms management regimen or start twice-daily naproxen 500 mg for 8 weeks. Patients then switched to their preferred regimen and were followed for 48 weeks in total. Results Of 201 patients, 89.6% did not experience new/worsening flu-like symptoms during their first 8 weeks on peginterferon beta-1a. Flu-like symptom severity remained low in current-regimen and naproxen patients, with no significant between-group differences. Median flu-like symptom duration per injection was 3.2 hours longer with peginterferon beta-1a versus prior interferon, but the 4-week cumulative duration was reduced 49–78%. No new safety signals were identified. Conclusion Most patients who switched from non-pegylated interferon to peginterferon beta-1a did not experience new/worsening flu-like symptoms. Flu-like symptom duration per injection increased, but the cumulative duration significantly decreased. These data may inform flu-like symptom management guidance.

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