Immune response to vaccines is maintained in patients treated with dimethyl fumarate

Hehn, Christian von; Howard, Jonathan; Liu, Shifang; Meka, Ven; Pultz, Joe; Mehta, Devangi; Prada, Claudia; Ray, Soma; Edwards, Michael; Sheikh, Sarah

doi:10.1212/nxi.0000000000000409

Cited by 78 publications

(84 citation statements)

References 21 publications

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“…A recent study with DMF in multiple sclerosis patients has reported that patients mounted an adequate immune response to inactivated vaccines. 66 There is no evidence of an impaired immune response to vaccination and in daily clinical practice, patients are not advised to suspend FAE treatment before vaccination with inactivated (as against live) vaccines.…”

Section: Can Patients Receive Vaccinations While Being Treated With Dmf?mentioning

confidence: 99%

Clinical use of dimethyl fumarate in moderate‐to‐severe plaque‐type psoriasis: a European expert consensus

Mrowietz¹,

Barker

Boehncke

et al. 2018

Acad Dermatol Venereol

124

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Fumaric acid esters (FAEs) are a group of small molecules that were first investigated for the treatment of psoriasis in 1959. The first fumarate‐based drug – Fumaderm® – was approved in Germany in 1994 for severe psoriasis and then in 2008, the label was expanded to include moderate psoriasis. Fumaderm is a combination of different FAEs: dimethyl fumarate (DMF), which is regarded as the main active component, plus calcium, magnesium and zinc salts of monoethyl fumarate (MEF). FAEs are the most frequently used first‐line systemic psoriasis treatment in Germany, with an overall treatment experience comprising more than 220 000 patient‐years. FAEs have demonstrated good, sustained clinical efficacy with an acceptable safety profile for the long‐term treatment of patients with moderate‐to‐severe psoriasis. Indeed, the European S3‐Guideline on the systemic treatment of Psoriasis vulgaris recommends FAEs for induction and long‐term treatment. Until recently, FAEs were only licensed (for the psoriasis indication) in Germany, but were imported to many other European countries, such as The Netherlands, UK, Ireland, Austria and Italy, for the treatment of psoriasis. In 2017, the European Medicines Agency (EMA) approved Skilarence®, a new oral formulation of DMF, for the treatment of adult patients with moderate‐to‐severe chronic plaque psoriasis in need of systemic therapy. Skilarence only contains DMF and is the first FAE for the treatment of psoriasis that has been approved by the EMA. This approval has given rise to a new oral treatment option for patients with moderate‐to‐severe plaque psoriasis across Europe. Here, we report the results of an expert meeting which was convened to deliver clinician‐agreed consensus and real‐world guidance on the clinical use of DMF in moderate‐to‐severe chronic plaque psoriasis. Guidance on appropriate patient selection, DMF dosage considerations, monitoring and side‐effect management is offered based upon available evidence and collective real‐world clinical experience.

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Section: Can Patients Receive Vaccinations While Being Treated With Dmf?mentioning

confidence: 99%

Clinical use of dimethyl fumarate in moderate‐to‐severe plaque‐type psoriasis: a European expert consensus

Mrowietz¹,

Barker

Boehncke

et al. 2018

Acad Dermatol Venereol

124

View full text Add to dashboard Cite

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“…33 There is insufficient evidence to support or refute whether individuals with MS receiving DMF are likely to differ in response to TT, diphtheria toxoid, pneumococcal, or meningococcal vaccination compared with participants with MS receiving IFN-β. 34 There is insufficient evidence to support or refute whether individuals with MS receiving alemtuzumab are likely to differ in response to Haemophilus influenzae type b, meningococcal, or pneumococcal polysaccharide vaccines compared with HCs. 35 There is insufficient evidence to support or refute whether individuals with MS receiving IFN-β therapy are likely to differ in response to BCG vaccination compared with individuals with MS not receiving such treatment.…”

Section: Tetanus Toxoid Vaccinationmentioning

confidence: 99%

Practice guideline update summary: Vaccine-preventable infections and immunization in multiple sclerosis

et al. 2019

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ObjectiveTo update the 2002 American Academy of Neurology (AAN) guideline regarding immunization and multiple sclerosis (MS).MethodsThe panel performed a systematic review and classified articles using the AAN system. Recommendations were based on evidence, related evidence, principles of care, and inferences according to the AAN 2011 process manual, as amended.Major recommendations (Level B except where indicated)Clinicians should discuss the evidence regarding immunizations in MS with their patients and explore patients' opinions, preferences, and questions. Clinicians should recommend that patients with MS follow all local vaccine standards, unless there are specific contraindications and weigh local vaccine-preventable disease risks when counseling patients. Clinicians should recommend that patients with MS receive the influenza vaccination annually. Clinicians should counsel patients with MS about infection risks associated with specific immunosuppressive/immunomodulating (ISIM) medications and treatment-specific vaccination guidance according to prescribing information (PI) and vaccinate patients with MS as needed at least 4–6 weeks before initiating patients' ISIM therapy. Clinicians must screen for infections according to PI before initiating ISIM medications (Level A) and should treat patients testing positive for latent infections. In high-risk populations, clinicians must screen for latent infections before starting ISIM therapy even when not specifically mentioned in PI (Level A) and should consult specialists regarding treating patients who screen positive for latent infection. Clinicians should recommend against using live-attenuated vaccines in people with MS receiving ISIM therapies. Clinicians should delay vaccinating people with MS who are experiencing a relapse.

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“…An IFN-β-controlled study examined the effectiveness of vaccination in MS patients treated with dimethyl fumarate (DMF) [107]. There were no significant differences in T-cell-dependent recall response (both 68% of DMF-treated patients and 73% of IFN-β-treated patients had ≥2-fold increase in IgG), lower but non-significant T-cell independent humoral response (66% of DMF-treated vs. 79% IFN-β-treated) and no differences in the response towards neoantigen, with 53% of both DMF-and IFN-β-treated MS patients developing immunity towards meningococcal C [107]. A similar vaccine design was employed for a pilot study in 25 MS patients treated with alemtuzumab, which were compared to literature controls [108].…”

Section: The Remaining Studies Utilize a Range Of Vaccines That Wouldmentioning

confidence: 99%

Infections, Vaccines and Autoimmunity: A Multiple Sclerosis Perspective

et al. 2020

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Background: Multiple sclerosis (MS) is a chronic neuroinflammatory and neurodegenerative disease that is associated with multiple environmental factors. Among suspected susceptibility events, studies have questioned the potential role of overt viral and bacterial infections, including the Epstein Bar virus (EBV) and human endogenous retroviruses (HERV). Furthermore, the fast development of immunomodulatory therapies further questions the efficacy of the standard immunization policies in MS patients. Topics reviewed: This narrative review will discuss the potential interplay between viral and bacterial infections and their treatment on MS susceptibility and disease progression. In addition, the review specifically discusses the interactions between MS pathophysiology and vaccination for hepatitis B, influenza, human papillomavirus, diphtheria, pertussis, and tetanus (DTP), and Bacillus Calmette-Guerin (BCG). Data regarding potential interaction between MS disease modifying treatment (DMT) and vaccine effectiveness is also reviewed. Moreover, HERV-targeted therapies such as GNbAC1 (temelimab), EBV-based vaccines for treatment of MS, and the current state regarding the development of T-cell and DNA vaccination are discussed. Lastly, a reviewing commentary on the recent 2019 American Academy of Neurology (AAN) practice recommendations regarding immunization and vaccine-preventable infections in the settings of MS is provided. Conclusion: There is currently no sufficient evidence to support associations between standard vaccination policies and increased risk of MS. MS patients treated with immunomodulatory therapies may have a lower benefit from viral and bacterial vaccination. Despite their historical underperformance, new efforts in creating MS-based vaccines are currently ongoing. MS vaccination programs follow the set back and slow recovery which is widely seen in other fields of medicine.

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Immune response to vaccines is maintained in patients treated with dimethyl fumarate

Cited by 78 publications

References 21 publications

Clinical use of dimethyl fumarate in moderate‐to‐severe plaque‐type psoriasis: a European expert consensus

Clinical use of dimethyl fumarate in moderate‐to‐severe plaque‐type psoriasis: a European expert consensus

Practice guideline update summary: Vaccine-preventable infections and immunization in multiple sclerosis

Infections, Vaccines and Autoimmunity: A Multiple Sclerosis Perspective

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