Predictors of disease flare after discontinuation of concomitant methotrexate in Japanese patients with rheumatoid arthritis treated with tocilizumab - 28/11/20
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Highlights |
• | Of RA patients with sustained low disease activity receiving tocilizumab plus methotrexate, 69.4% maintained low disease activity at 52weeks after methotrexate discontinuation. |
• | Male patients and those receiving tocilizumab at an extended dosing interval were at high risk of disease flare after discontinuation of concomitant methotrexate. |
• | Methotrexate discontinuation reduced the prevalence of gastroesophageal reflux disease in RA patients. |
Abstract |
Objective |
To investigate predictors of disease flare after methotrexate discontinuation in Japanese rheumatoid arthritis (RA) patients with sustained low disease activity undergoing tocilizumab plus methotrexate combination therapy.
Methods |
Participants of this multicenter, open-label, uncontrolled, prospective study were RA patients maintaining low disease activity (Clinical Disease Activity Index [CDAI]≤10) for≥12weeks with tocilizumab plus methotrexate. Methotrexate was discontinued after 12weeks of biweekly administration while continuing tocilizumab therapy. Disease flare was defined as either a CDAI score>10 or intervention with rescue treatments for any reason even if the CDAI score was≤10. The impact of baseline characteristics on disease flare at week 64 (52weeks after methotrexate discontinuation) was assessed with logistic regression models.
Results |
Efficacy analyses were performed in 49 patients, of whom 15 had a disease flare by week 64. The proportion (95% confidence interval [CI]) of patients who maintained low disease activity without a flare at week 64 was 69.4% (54.6–81.8%). The dosing interval of tocilizumab was longer than that described on the drug label in Japan (i.e., intravenously every 4weeks, or subcutaneously every 2weeks) in 27% and 6% of patients with and without a flare, respectively. Multivariate analysis revealed that male sex (odds ratio [OR]: 18.00, 95% CI: 2.80–115.56) and extended dosing interval of tocilizumab (OR: 12.00, 95% CI: 1.72–83.80) were independent predictors of disease flare.
Conclusion |
Male patients and those receiving tocilizumab at an extended dosing interval are at high risk of disease flare after discontinuation of concomitant methotrexate.
Trial registration number |
jRCTs041180071, UMIN000021247.
Il testo completo di questo articolo è disponibile in PDF.Keywords : Rheumatoid arthritis, Tocilizumab, Methotrexate, Symptom flare up, Clinical trial
Mappa
Vol 87 - N° 6
P. 596-602 - Dicembre 2020 Ritorno al numero
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