Objective: Pharmacotherapy management of systemic autoimmune disorders is challenging due to the high disease relapse rate and requires chronic complex treatment regimens. Adverse drug reactions (ADRs) are the fourth leading cause of death worldwide. Hence, monitory of ADRs become essential to achieve desired therapeutic outcomes. Therefore, this study was conducted to assess the ADRs and their risk factors among systemic autoimmune disorder patients.

METHODS: A cross-sectional study was conducted at the rheumatology department in a tertiary care teaching hospital for twenty-two months. Patients diagnosed with rheumatoid arthritis, systemic lupus erythematosus, systemic vasculitis, and psoriasis of both gender and aged ≥ 16 years were included in this study. A clinical pharmacist participated in daily ward round or visited outpatient clinic to review patients' medical conditions and medication details to identify the suspected ADRs. Naranjo probability scale was used for causality assessment, Modified Hartwig and Siegel scale was used for severity assessment and Schumock and Thornton scale was used for assessment of preventability. Logistic regression analysis was used to identify the associated risk factors of ADRs, using SPSSv25.

RESULTS:

A total of 860 patients were investigated. Of them, 226 ADRs were identified among 184/860 (21.3%) patients. Most of the identified ADRs were related to methotrexate (87/226, 38.4%) and prednisolone (42/226, 18.5%). Causality assessment shows majority of ADRs were probable (119, 52.6%), possible (77, 34.0%) and definite (30, 13.2%) in type. Of them, most ADRs were moderate in severity (147, 65.0%) and preventable type (91, 40.2%). The most common risk factor identified that associated with the ADRs was patients taking ≥10 drugs (OR 7.04, P<000.1).

CONCLUSION: This study reveals that pharmacotherapy management of systemic autoimmune disorders is associated with ADRs development is high. Thus, early detection of ADRs and their associated risk factors, and appropriately managing ADRs can help to avoid further complications.