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The article presents guidelines on prescribing comorbidity medications used in rheumatology practice to pregnant and breastfeeding women from the British Society for Rheumatology. The objective is to update previous guidelines on prescribing for drug categories like pain management, anticoagulants and anti-hypertensives. It excludes the management of infertility or acute pain relief during labour.

The article presents guidelines on prescribing comorbidity medications used in rheumatology practice to pregnant and breastfeeding women from the British Society for Rheumatology. The objective is to update previous guidelines on prescribing for drug categories like pain management, anticoagulants and pulmonary vasodilators. It excludes the management of infertility or acute pain relief during labour.

The article presents guidelines on prescribing immunomodulatory anti-rheumatic drugs and corticosteroids to pregnant and breastfeeding women from the British Society for Rheumatology. The objective is to update the previous guidelines and highlight medications that have to be stopped and avoided in the reproductive age group. It excludes the management of infertility or the indications for the drugs in rheumatic diseases in pregnancy.

The article presents guidelines on prescribing immunomodulatory anti-rheumatic drugs and corticosteroids to pregnant and breastfeeding women from the British Society for Rheumatology. Uncertainty over the use of the drugs in pregnancy and breastfeeding has led to the expansion of existing and novel disease-modifying antirheumatic drugs. The guideline excludes the management of infertility or indications in specific rheumatic diseases in pregnancy.

Introduction: Free‐of‐charge (FoC) medicine schemes are increasingly available and allow access to investigational treatments outside clinical trials or in advance of licensing or NHS commissioning. Methods: We retrospectively reviewed FoC medicine schemes evaluated between 2013 and 2019 by a single NHS trust and a regional drug and therapeutics committee (DTC). The details of each locally reviewed FoC scheme, and any nationally available Medicines and Healthcare products Regulatory Agency Early Access to Medicines Scheme (MHRA EAMS) in the same period, were recorded and categorised. Results: Most FoC schemes (95%) allowed access to medicines intended to address an unmet clinical need. Over 7 years, 90% were company‐FoC schemes and 10% were MHRA EAMS that were locally reviewed. Phase 3 clinical trial data were available for 44% of FoC schemes, 37% had phase 2 data and 19% were supported only by phase 1 data, retrospective observational studies or preclinical data. Utilisation of company‐FoC schemes increased on average by 50% per year, while MHRA EAMS schemes showed little growth. Conclusion: Company‐FoC medicine schemes are increasingly common. This may indicate a preference for pharmaceutical companies to independently co‐ordinate schemes. Motivations for company‐FoC schemes remain unclear and many provide access to treatments that are yet to be evaluated in appropriately conducted clinical trials, and whose efficacy and risk of harm remain uncertain. There is no standardisation of this practice and there is no regulatory oversight. Moreover, no standardised data collection framework is in place that could demonstrate the utility of such programmes in addressing unmet clinical need or to allow generation of further evidence. [ABSTRACT FROM AUTHOR]

Aims To assess the transfer of patients treated with originator biological therapies to biosimilar products in a large UK tertiary referral hospital reflecting practice within the National Health Service (NHS) using prospectively collected data by a hospital‐based registry administered by the Biologics Steering Group (BSG). Methods: We analysed data collected prospectively in a hospital‐based registry in a large NHS tertiary referral hospital in the UK. The registry was administered by the hospital's BSG, which considered requests for patients to remain on or revert to originator products. The registry contained prospectively collected data on patients switching therapy from an originator to a biosimilar. The data included clinical circumstances or rationale for each request, whether it was granted, and the results of clinical reviews at 3–6 months. Results: In a 12‐month period, we identified 1299 patients who could switch to the respective biosimilar and, of these, 1196 (92%) did so. Of the 260 patients taking infliximab, 250 (96%) switched to infliximab biosimilar; of the 390 patients taking etanercept 50 mg, 298 (76%) switched to etanercept 50 mg biosimilar; and of the 649 patients taking rituximab, 648 (99%) switched to rituximab biosimilar. The BSG received 39 applications: 12 (out of 39) applications were to remain on the originator and 27 (out of 39) were to switch back to the originator. Of the applications to remain on the originator 10 (out of 12) were approved. At 3–6 month review, 2 of these approvals reported continued efficacy, 3 switched to the biosimilar, 3 switched to an alternative therapy and 2 stopped treatment. Two (out of 10) applications were not approved, both applicants reported efficacy with the biosimilar at follow up. Of the 27 applications to switch back to the originator, 16 (out of 27) applications were approved. At 3–6 months, 9 (out of 16) applicants reported regain of efficacy, 6 (out of 16) reported cessation of reported adverse effects and 1 (out of 16) switched to alternative therapy. Eight (out of 27) applications were not approved, and, at point of follow up, 50% reported efficacy with the biosimilar and 50% had switched to an alternative therapy. Three (out of 27) applications were withdrawn by the clinical team as efficacy was achieved with the biosimilar. Conclusion: We have set up a system within a busy NHS clinical practice to successfully switch patients to biosimilars, and established a mechanism to guide decisions on continuing with or reverting back to the originator. Such a system could be of use more broadly within the NHS and other health care systems. [ABSTRACT FROM AUTHOR]