Table 3.
Overview of statements from European prescribing documentation for disease-modifying therapies (DMTs) for MS regarding risks of infection and application of vaccination
| DMT | Statements on risk of infection | Statements on vaccination |
|---|---|---|
| Interferon-β | None | None |
| Glatiramer acetatea | Infection, influenza, bronchitis, gastroenteritis, herpes simplex, otitis media, rhinitis, tooth abscess, vaginal candidiasis are listed as “very common”b or “common”c side effects | None |
| Dimethyl fumarate | Do not initiate during severe active infection and consider suspending treatment if serious infection develops | Inactivated vaccines were safe and effective during treatment; avoid use of attenuated live vaccines |
| Teriflunomide | No increase in serious infections. Monitor infections carefully and consider withdrawal for serious infections | Non-live vaccines may be considered during treatment, but avoid use of attenuated live vaccines |
| Fingolimod | Serious, life-threatening/fatal cases of encephalitis, meningitis or meningoencephalitis caused by herpes simplex and VZV have occurred; HPV has also been reported | Fingolimod may reduce the effectiveness of vaccinations for up to 2 months after treatment. Vaccinate for VZV in antibody-negative patients 1 month before treatment initiation. Consider vaccination for HPV before initiation. Avoid use of attenuated live vaccines |
| Natalizumab | Testing for antibodies to JCV is recommended prior to initiation. Monitor regularly for PML or GCN. Screen for PML regularly using MRI for high-risk patients.d Suggestion of increased risk of herpes or VZV infections | No or minor effect on the efficacy of vaccinations has been observed. No data on live vaccines |
| Cladribine tablets | Risk of activation of latent infections, including TB, hepatitis and herpes zoster (treat infections before initiation) | Vaccinate for VZV in antibody-negative patients 4–6 weeks before treatment initiation. Avoid use of live or attenuated live vaccines while WBC counts are outside normal limits |
| Ocrelizumab | PML has been observed with other anti-CD20 agents (evaluate suspected cases with MRI). Reactivation of hepatitis B has been observed (screen/treat as necessary) | Avoid live or attenuated live vaccines while B lymphocytes are depleted. Inactivated seasonal influenza vaccines are preferred. Perform any required vaccination at least 6 weeks before initiation |
| Alemtuzumab | URTI, UTI, herpes zoster, LRTI, gastroenteritis, oral candidiasis, vulvovaginal candidiasis, influenza, ear infection, pneumonia, vaginal infection, tooth infection are described as “common”b or “very common”c side effects | Avoid live vaccines in recently treated patients. Consider VZV vaccination for antibody-negative patients before initiation. Delay initiation for at least 6 weeks after any vaccine |
Information was abstracted from European Summaries of Product Characteristics. Interferon-β1a (Rebif®, Merck KGaA) was used as an example of this class of DMT. Statements have been edited for conciseness: always consult the full documentation before prescribing. Recommendations on vaccination assume no contraindications. aNot available for prescription in the Arabian Gulf. Side effects expected in at least b10% or c1% of patients; “uncommon” side effects (< 1% of patients) are not shown here for clarity. dPatients who are anti-JCV antibody positive with more than 2 years of treatment with natalizumab therapy, who have also have received prior immunosuppressant therapy or patients with a high anti-JCV antibody index who have received more than 2 years of natalizumab without prior immunosuppression. GCN granule cell neuronopathy, JCV John Cunningham virus, LRTI lower respiratory tract infection, PML progressive multifocal leukoencephalopathy, TB tuberculosis, URTI upper respiratory tract infection, UTI urinary tract infection, VZV varicella zoster virus, WBC white blood cell