RESUMEN
OBJECTIVE: The glucocorticoid toxicity index (GTI) is developed to measure glucocorticoid (GC)-related morbidity over time. This study aimed to assess GC-toxicity in patients at a rheumatology outpatient clinic by using the GTI and to identify the factors that interfere with the GTI. METHODS: This prospective study included patients with inflammatory arthritis (IA), connective tissue disease, and vasculitis who were newly prescribed GC-treatment (GC-naive) or have been still on GC-treatment for ≤2 years (GC-experienced). Patient demographics and disease characteristics, aggregate improvement score (GTI-AIS), cumulative worsening score (GTI-CWS), and cumulative GC-doses were recorded at baseline, 3rd month, and 6th month. Generalized estimating equations (GEE) were used to evaluate the GTI scores and associated factors including cumulative GC-doses. RESULTS: The study included 156 (48.7% GC-naive) patients with a mean age of 49.1 ± 17.1 years. More than half of the patients in both groups had a diagnosis of vasculitis. A higher cumulative GC-dose was found to be associated with higher GTI-scores in both groups (p< 0.001). In the GC-naive group, patients with vasculitis showed higher GTI-scores than IA patients (p< 0.001); there was also a significant increase in the GTI-CWS at the 6th month compared with the 3rd month. In the GC-experienced group, GTI-AIS and GTI-CWS were significantly different at 3rd and 6th month (p< 0.05). CONCLUSION: It was shown that GTI scores were associated with cumulative GC-doses and vasculitis patients in the GC-naive patients had higher GTI scores than inflammatory arthritis. The GTI allows individualized assessment and management of adverse effects experienced by patients as a result of GC treatment.
RESUMEN
Biosimilars offer cost-effective and safe treatment options both for patients and healthcare systems. CT-P10 is the first biosimilar of rituximab approved in Europe for use in all indications of originator rituximab (oRTX). This study aimed to provide real-life data on treatment changes and adverse events in patients who received oRTX or CT-P10. We retrospectively reviewed treatment-related adverse events [infusion-related reactions (IRRs), infections, hypogammaglobulinemia] in patients treated with at least one dose of oRTX (MabThera®) or CT-P10 (Truxima®) between 2020 and 2021 and had at least 6 months follow-up after rituximab infusion in a rheumatology clinic. The switches between oRTX and CT-P10 were performed according to drug availability at the hospital pharmacy at the time of infusion according to the local hospital procedure. Physicians were not involved in the decision of biosimilar selection. A total of 128 patients (CT-P10, n = 64; oRTX, n = 64) were included. CT-P10 was switched in 52 (40.6%) patients who had previously used oRTX, and 48 (37.5%) patients remained on oRTX. We demonstrated no difference between patients treated with oRTX or CT-P10 in the rates of IRRs, in which all reactions were grade 1 and 2. Comparable rates of infections (p > 0.05) and the rate of hypogammaglobulinemia (p > 0.05) were found in both groups with no significant difference. CT-P10 provides a safe treatment alternative in patients who require rituximab therapy. The rational use of biosimilars can be supported by evolving evidence on interchangeability and switching in real-life settings, which will help clinicians in decision-making.
