Doklady. Biochemistry and biophysics · 2026
Efficacy and Safety of Rapid Dose Escalation of Methotrexate in Rheumatoid Arthritis (Results of the Multicenter METEOR Study).
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Amirdzhanova V N, Polischuk E Yu, Anoshenkova O N, Vinogradova I B, Zonova E V, Ivanova L V, Samigullina R R, Salnikova T S, Shakhramanova E L, Schmidt E I, Yakupova S P, Lila A M, Nasonov E L
Аннотация
UNLABELLED: The aim of the study was to analyze the effectiveness and tolerability of subcutaneous methotrexate (sc MTX) (METHORTRIT; sc ROMPHARM Company) in RA patients with high disease activity with rapid dose escalation, to assess their quality of life (QOL) in real clinical practice.
MATERIALS AND METHODS: -The study included 105 patients, mostly women, with a reliable diagnosis of RA with high disease activity (DAS28 ≥ 5.1) aged 18 years and older and ineffectiveness of previous oral MT therapy for at least 6 months or who had not received MT. sc MTX therapy was started at a dose of 15 mg /weekly. During the first month of therapy, a rapid escalation of the scMTX dose of 2.5 mg/week was performed once a week until the dose of 22.5 mg/week was reached; then, with insufficient response, the dose of sc MTX could be increased to 25 mg/week. The evaluation of the effectiveness of therapy, functional status, and QOL was carried out after 4-12-18-24 weeks.
RESULTS: -After a rapid escalation of the sc MTX dose during the first month of the study, at all stages of follow-up, a rapid decrease in disease activity was noted for all standard indices (DAS28 from 5.8 ± 0.75 to 2.93 ± 1.05; CDAI from 30.13 ± 8.33 to 7.08 ± 6.07; SDAI from 32.78 ± 9.64 to 7.48 ± 6.53) and the activity index, which was evaluated by the patients themselves (RAPID-3 from 16.18 ± 4.6 to 5.56 ± 4.66), p ≤ 0.05. The number of patients with high disease activity according to DAS28 decreased by 2 times by the 4th week of therapy (to 46.2%), after 12 weeks they remained 13.3%, and by 24 weeks high activity remained only in 4.4% of patients. There was a marked decrease in pain from 65.6 ± 13.07 to 20.5 ± 17.1 mm in VAS (p < 0.001), which contributed to an improvement in the functional state: the HAQ index decreased on average from 1.47 ± 0.65 to 0.64 ± 052 points. Population indices of functional status (HAQ ≤ 0.5) by the 24th week of therapy were observed in 48.9% of patients. A decrease in the level of fatigue (from 6.25 ± 7.04 to 1.81 ± 1.71 cm according to VAS, p < 0.001) was accompanied by a decrease in anxiety (from 7.47 ± 4.03 to 2.36 ± 2.72, p < 0.001) and depression (from 7.77 ± 3.84 to 2.50 ± 2.56, p < 0.001), as well as improved sleep. By the 24th week of the study, 45% of patients had population-based indices of QOL according to the EQ-5D index. Glucocorticoids (GC) were completely eliminated in 2/3 of the patients. Patients who did not receive GC had lower disease activity by 24 weeks in all indices: DAS 28 (2.7 ± 0.1 and 3.4± 0.2, respectively), CDAI (6.0 ± 0.3 and 10.2 ± 0.1), SDAI (6.4 ± 0.2 and 10.9 ± 0.3), p < 0.05. Patients receiving and not receiving GC had the same number of adverse reactions (p > 0.05); however, the number of infections in patients receiving GC was significantly higher (9.5%-0.0, respectively, p = 0.009). The need for nonsteroidal anti-inflammatory drugs (NSAIDs) at the beginning of the study was in 93.2% of patients on average 21.1 days per month; after 24 weeks, the need for NSAIDs was in 54.4% of patients on average 3.8 days per month. In general, the safety profile of MTX was acceptable.
CONCLUSIONS: -With high RA activity, the tactics of starting therapy with sc MTX at a dose of 15 mg per week and a rapid escalation of its dose of 2.5 mg weekly to 22.5-25 mg/week, allows achieving therapy goals by 3 months in 17.8% of patients, and by 6 months in 64.5%, to quickly improve the QOL, reduce the level of pain, reduce the dose of GC by 3 months of therapy or completely cancel them, and reduce the need for NSAIDs by 7 times with an acceptable level of therapy safety.
MATERIALS AND METHODS: -The study included 105 patients, mostly women, with a reliable diagnosis of RA with high disease activity (DAS28 ≥ 5.1) aged 18 years and older and ineffectiveness of previous oral MT therapy for at least 6 months or who had not received MT. sc MTX therapy was started at a dose of 15 mg /weekly. During the first month of therapy, a rapid escalation of the scMTX dose of 2.5 mg/week was performed once a week until the dose of 22.5 mg/week was reached; then, with insufficient response, the dose of sc MTX could be increased to 25 mg/week. The evaluation of the effectiveness of therapy, functional status, and QOL was carried out after 4-12-18-24 weeks.
RESULTS: -After a rapid escalation of the sc MTX dose during the first month of the study, at all stages of follow-up, a rapid decrease in disease activity was noted for all standard indices (DAS28 from 5.8 ± 0.75 to 2.93 ± 1.05; CDAI from 30.13 ± 8.33 to 7.08 ± 6.07; SDAI from 32.78 ± 9.64 to 7.48 ± 6.53) and the activity index, which was evaluated by the patients themselves (RAPID-3 from 16.18 ± 4.6 to 5.56 ± 4.66), p ≤ 0.05. The number of patients with high disease activity according to DAS28 decreased by 2 times by the 4th week of therapy (to 46.2%), after 12 weeks they remained 13.3%, and by 24 weeks high activity remained only in 4.4% of patients. There was a marked decrease in pain from 65.6 ± 13.07 to 20.5 ± 17.1 mm in VAS (p < 0.001), which contributed to an improvement in the functional state: the HAQ index decreased on average from 1.47 ± 0.65 to 0.64 ± 052 points. Population indices of functional status (HAQ ≤ 0.5) by the 24th week of therapy were observed in 48.9% of patients. A decrease in the level of fatigue (from 6.25 ± 7.04 to 1.81 ± 1.71 cm according to VAS, p < 0.001) was accompanied by a decrease in anxiety (from 7.47 ± 4.03 to 2.36 ± 2.72, p < 0.001) and depression (from 7.77 ± 3.84 to 2.50 ± 2.56, p < 0.001), as well as improved sleep. By the 24th week of the study, 45% of patients had population-based indices of QOL according to the EQ-5D index. Glucocorticoids (GC) were completely eliminated in 2/3 of the patients. Patients who did not receive GC had lower disease activity by 24 weeks in all indices: DAS 28 (2.7 ± 0.1 and 3.4± 0.2, respectively), CDAI (6.0 ± 0.3 and 10.2 ± 0.1), SDAI (6.4 ± 0.2 and 10.9 ± 0.3), p < 0.05. Patients receiving and not receiving GC had the same number of adverse reactions (p > 0.05); however, the number of infections in patients receiving GC was significantly higher (9.5%-0.0, respectively, p = 0.009). The need for nonsteroidal anti-inflammatory drugs (NSAIDs) at the beginning of the study was in 93.2% of patients on average 21.1 days per month; after 24 weeks, the need for NSAIDs was in 54.4% of patients on average 3.8 days per month. In general, the safety profile of MTX was acceptable.
CONCLUSIONS: -With high RA activity, the tactics of starting therapy with sc MTX at a dose of 15 mg per week and a rapid escalation of its dose of 2.5 mg weekly to 22.5-25 mg/week, allows achieving therapy goals by 3 months in 17.8% of patients, and by 6 months in 64.5%, to quickly improve the QOL, reduce the level of pain, reduce the dose of GC by 3 months of therapy or completely cancel them, and reduce the need for NSAIDs by 7 times with an acceptable level of therapy safety.