Types of studies
Studies meeting the following criteria were included:
randomised controlled studies with adequate methods of concealment of randomisation;
single, double-blind or unblinded;
with no minimum treatment period.
Types of participants
Adults (over 16 years) of either gender with focal epilepsy syndromes. This includes patients with a recent diagnosis as well as those with chronic epilepsy.
Types of interventions
The experimental interventions include glucocorticosteroids or immunosuppressants by oral, intravenous, intramuscular or subcutaneous route taken in addition to AEDs.
Glucocorticosteroids include hydrocortisone, prednisolone, methylprednisolone and dexamethasone.
Immunosuppressants include intravenous immunoglobulins, azathioprine, mycophenolic acid, leflunomide, teriflunomide, methotrexate, tacrolimus, ciclosporin, pimecrolimus, abetimus, gusperimus, thalidomide, lenalidomide, etanercept, pegsunercept, anakinra, sirolimus, deforolimus, everolimus, temsirolimus, zotarolimus, biolimus A9, ecluzimab, infliximab, adalimumab, certolizumab pegol, afelimomab, golimumab, mepolizumab, omalizumab, faralimomab, elsilimomab, lebrikizumab, ustekinumab, muromonab-CD3, otelixizumab, teplizumab, visilizumab, clenoliximab, keliximab, zanolimumab, efalizumab, erlizumab, rituximab, afutuzumab, ocrelizumab, pascolizumab, lumiliximab, teneliximab, toralizumab, aselizumab, galiximab, gavilimomab, ruplizumab, belimumab, ipilimumab, tremelimumab, bertilimumab, lerdelimumab, metelimumab, natalizumab, tocilizumab, basiliximab, daclizumab, inolimomab, zolimomab aritox, atorolimumab, cedelizumab, dorlixizumab, fontolizumab, gantenerumab, gomiliximab, maslimomab, morolimumab, pexelizumab, reslizumab, rovelizumab, siplizumab, talizumab, vapaliximab and vepalimomab.
Control interventions include placebo, no additional treatment or another immunomodulatory drug intervention analysed separately.
Types of outcome measures
Seizure freedom: proportion of patients that achieve complete seizure cessation during the treatment period.
50% or greater reduction in seizure frequency compared to baseline seizure frequency.
The proportion of patients experiencing any of the following side effects that are considered by the review authors to be common and important side effects of immunomodulatory drugs:
All adverse effects secondary to glucocorticoids, including:
impaired glucose tolerance;
All adverse effects secondary to long-term immunomodulation including:
induction of malignancy.
Cognitive side effects including confusion, delirium, drowsiness and sedation.
Other serious side effects (as defined by the European Medicines Agency (EMEA 1995)):
results in death;
requires inpatient hospitalisation or prolongation of existing hospitalisation;
results in persistent or significant disability/incapacity;
is a congenital anomaly/birth defect; or
requires intervention to prevent permanent impairment or damage.
Patients that experience any adverse effect.
Withdrawal due to intolerable side effects or lack of efficacy.
Quality of life using a validated score.