The most compelling argument to proactively monitor the safety and optimal use of drugs in GPA is the off-label status of most drugs except rituximab, because their marketing approval and associated therapeutic recommendations are not based on GPA-specific data. Finally, pharmacists, whether in a hospital or community setting, can play an important role in improving medication use in GPA by conducting medication reviews and reconciliation.
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Rare disease patient organizations can help to educate patients, empowering them to participate actively in their own healthcare by giving them the confidence to voice concerns to their healthcare professionals, understand where and when to seek professional advice, and participate in support groups where patients can encourage each other to persist with their treatment plans. Effective communication between clinicians across care settings before prescribing or de-prescribing can improve drug safety. Such a situation may occur if clinicians prescribe or de-prescribe drugs without due consideration of the patients’ current medication, potentially giving rise to prescribing cascades. This can significantly improve patient care but poses a risk of conflicting treatment plans if the diverse prescribing practices are not harmonized. Drug safety considerations in GPA are complex since patients likely receive multi-disciplinary care from awide range of specialists.
Glucocorticoids, as well as azathioprine, methotrexate, and rituximab, are also known to cause immunosuppression, increasing infection risk. There are several adverse drug reactions (ADRs) with long-term use of glucocorticoids, including hyperglycemia and diabetes. GPA patients suffering from metabolic syndrome have an increased risk of GPA relapse, highlighting the need to study multimorbidity in these patients to improve clinical outcomes. In addition to the symptoms of GPA, patients are likely to have other chronic conditions, such as hypertension, dyslipidaemia and diabetes mellitus which can lead to a higher burden of medication use and an altered drug risk-benefit profile. Furthermore, patients with loco-regional symptoms can be treated with antimicrobial treatment, adding to the burden of polypharmacy . Rituximab can be used in a fixed treatment regimen with no planned discontinuation, fixed treatment intervals in patients with relapsing disease or in newly diagnosed patients, or retreating with rituximab. There is also no consensus on the therapeutic regimen using rituximab, the only drug explicitly indicated for use in GPA both by the European Medicines Agency and by the Food and Drug Administration. However, there is no consensus on glucocorticoid discontinuation.
There is at least one drug in the pipeline which may potentially be used to speed up the process of discontinuing glucocorticoids in conditions similar to GPA. Glucocorticoid tapering is important to lower the risk of infection while avoiding relapse. Challenges in the pharmacological management of patients with GPAįour scientific societies have recommended long-term management of severe GPA in remission using low-dose oral glucocorticoids and an immunosuppressant, with azathioprine, methotrexate, and rituximab being most commonly recommended, although mycophenolate is also used.
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