Tocilizumab (TCZ), is a recombinant humanized anti-interleukin-6 receptor (IL-6R) monoclonal antibody which has a main use in the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis (sJIA) and polyarticular juvenile idiopathic arthritis (pJIA). This article provides an overview of TCZ including looking into the past at the discovery of interleukin-6 (IL-6) as a pro-inflammatory cytokine. It also looks at how tocilizumab was developed, manufactured and tested to ensure both safety and efficacy in a human population. The article then explores the advantages and disadvantages of using TCZ when compared to other biologics approved in RA, sJIA and pJIA and finally looks ahead to the future and the emerging role of IL-6 and its blockade by TCZ as a treatment for giant cell arteritis (GCA), polymyalgia rheumatica (PMR) and large vessel vasculitis (LVV).
BackgroundInfliximab is a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α), used to treat autoimmune diseases such as rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis.1 In 2015 NICE recommended the use of a new less expensive biosimilar CT-P13 (Remsima™; Inflectra™), based on its efficacy, safety and quality comparable to the reference infliximab product.2 At Southend University Hospital NHS Foundation Trust, the use of CT-P13 has reduced treatment costs and allowed significant cost savings compared with reference infliximab.ObjectivesTo review patient outcomes and estimate the cost savings of using CT-P13 as compared with reference infliximab.MethodsInformation packs were sent out to patients to inform them of the intended switch from Infliximab to CT-P13. Their understanding was further reinforced in a face-to-face session with the biologics pharmacist and any concerns were addressed. Additionally patients had access to a dedicated email account which was set up to deal with their queries. Written consent was obtained from patients prior to the switch. Patients were carefully monitored during the first infusion of CT-P13 and were advised to contact the rheumatology department if they developed any undue side-effects or loss of disease control. All eligible patients were offered a chance to recruit to BSR Biologics Register. All side-effects were reported to MHRA.Results25 patients consented to the switch from infliximab to the biosimilar CT-P13. 20 patients reported no new side-effects or loss of disease control (80%, ±15.68). 4 patients developed side-effects after switching to CT-P13. 1 developed flu like symptoms, 1 developed inflamed foreskin and 2 developed pruritic rashes, (one patient after the first dose and the other patient after the 4th dose). All patients who developed side-effects were successfully switched back to reference infliximab. 1 patient reported loss of disease control and is due to switch back at their next infusion. None of the patients initiating CT-P13 first line have developed any side-effects to date. A paired t-test has revealed no statistically significant difference in CRP values taken before and after the switch (n=21, p=0.151). £70k is expected to be saved based on this reported use of CT-P13 in our rheumatology department over 12 months.ConclusionsIn our cohort of patients, switching from Infliximab to CT-P13 appeared to be safe for the majority of patients and represents a significant opportunity to provide a more cost effective service in rheumatology. The immunogenic nature of infliximab highlights the importance of having a robust safety net strategy when switching patients to biosimilars. Further multi-centre studies are needed to corroborate our findings.ReferencesMerck Sharp & Dohme Limited. Summary of product Characteristics for Remicade. Updated 30/10/2015. [accessed 19/01/2016] Available from Committee for Medicinal Products for Human Use. Remsima EPAR Assessment report [Internet]. European Medical Agency [accessed 19/01/20...
The in vitro activity of the compound RU-51746, the sodium salt of cefpodoxime (which is administered orally as the ester cefpodoxime proxetil) was compared with that of other commonly used oral antibiotics against a selection of clinical isolates of common bacteria from patients with urinary tract, soft tissue and respiratory tract infections. RU-51746 was found to inhibit 90% of Enterobacteriaceae at less than 1 mg/l; pneumococci, pyogenic streptococci (Lancefield groups A, C and G) and Streptococcus agalactiae were almost all inhibited by concentrations of less than 0.06 mg/l; Haemophilus influenzae (including beta-lactamase producers) were inhibited by less than 1 mg/l; 90% of Branhamella catarrhalis were inhibited at less than 2 mg/l. Activity against Acinetobacter spp. and staphylococci was variable and enterococci were all resistant.
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