Adult dose and durationIntravenous infusion, dosed by body weight. SmPC verbatim: "5 mg/kg given as an intravenous infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter." - Stopped at 14 weeks if four doses have not worked. SmPC verbatim: "If a patient shows no response after 14 weeks (i.e. after 4 doses), no additional treatment with infliximab should be given."
Paediatric doseNot a paediatric prescription in this disease. SmPC verbatim: "The safety and efficacy of infliximab in children and adolescents younger than 18 years for the indication of psoriasis have not been established."
Dose sourceRemsima 100 mg powder for concentrate for solution for infusion (infliximab) SmPC sections 4.1, 4.2, 4.3 and 4.4 (eMC product 3709)
WhyThe disease article names it first among the biologics, verbatim: "Biologicals are manufactured proteins that interrupt the immune process in psoriasis which are infliximab, adalimumab, etanercept, and interleukin antagonists." and places it precisely, verbatim: "Infliximab is reserved for patients with severe disease in whom other biological agents cannot be used". The SmPC's indication section names the disease, verbatim: "Remsima is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporin, methotrexate or psoralen ultra-violet A (PUVA)." Egypt registers one infliximab product, REMICADE 100 mg powder for intravenous infusion at roughly 5,900 EGP a vial, and a course is several vials per infusion at adult body weights.
Cautions- RED FLAG - tuberculosis is excluded before the first infusion, not after it. SmPC verbatim: "Before starting treatment with infliximab, all patients must be evaluated for both active and inactive ('latent') tuberculosis." and "Appropriate screening tests, (e.g. tuberculin skin test, chest X-ray, and/or Interferon Gamma Release Assay), should be performed in all patients". The SmPC also warns that "in the majority of these reports tuberculosis was extrapulmonary". Latent tuberculosis is common in Egypt, so this is a real gate rather than a formality.
- Hepatitis is screened for alongside tuberculosis - the disease article asks for both to be worked up before any biological agent is started.
- Infection risk runs for months after the last infusion. SmPC verbatim: "Patients must be monitored closely for infections including tuberculosis before, during and after treatment with infliximab. Because the elimination of infliximab may take up to six months, monitoring should be continued throughout this period. Further treatment with infliximab must not be given if a patient develops a serious infection or sepsis." A blunted fever is part of the hazard - "suppression of TNF may mask symptoms of infection such as fever".
- Contraindicated outright in some patients. SmPC verbatim: "Patients with tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections" and "Patients with moderate or severe heart failure (NYHA class III/IV)".
- An intravenous hospital drug, not a prescription pad drug. SmPC verbatim: "Remsima infusions should be administered by qualified healthcare professionals trained to detect any infusion-related issues." and "Infliximab has been associated with acute infusion-related reactions, including anaphylactic shock, and delayed hypersensitivity reactions".