Disease activity and therapeutic drug monitoring of polyglutamates of methotrexate after daily or weekly administration of low-dose methotrexate in patients recently diagnosed with rheumatoid arthritis.
Ana Socorro Rodríguez-BáezAna Patricia Huerta-GarcíaSusanna Edith Medellín-GaribayCristian Jazmín Rodríguez-PinalMarco Ulises Martínez-MartínezDavid Herrera-Van OostdamCarlos Abud-MendozaSilvia Romano-MorenoRosa Del Carmen Milán-SegoviaPublished in: Basic & clinical pharmacology & toxicology (2022)
Low-dose methotrexate can be challenging to treat rheumatoid arthritis due to side effects, lack of adherence and risk of medication errors. The aim of this study was to explore the safety and efficacy of low-dose methotrexate administered daily or weekly in patients with rheumatoid arthritis. Patients were randomized according to a total oral dose of 12.5 mg of methotrexate administered: (A) divided in 5 days/week and (B) once per week. Patients were assessed along 24 weeks after starting treatment. Polyglutamates of methotrexate were quantified by ultrahigh-performance liquid chromatography coupled to tandem mass spectrometer. Patients from groups A and B showed a good response to methotrexate treatment in 29% and 25.5%, respectively, and a global frequency of adverse events of 37%. Methotrexate polyglutamate 3 concentrations were higher in normal weight (body mass index 18.5-24.9 kg/m 2 ) than in obese (body mass index 30 kg/m 2 ) patients with a median (interquartile range) of 28 (17.95-45.15) and 10.35 (5.22-30.88) nM without differences between dosage groups. Daily dosage regimen represents a therapeutic alternative without compromising the efficacy and safety of methotrexate treatment and with similar adherence patterns than weekly dosage regimen; further, methotrexate polyglutamate 3 concentrations could be a useful tool for therapeutic drug monitoring purposes.
Keyphrases
- high dose
- low dose
- rheumatoid arthritis
- disease activity
- body mass index
- end stage renal disease
- rheumatoid arthritis patients
- newly diagnosed
- ejection fraction
- physical activity
- systemic lupus erythematosus
- peritoneal dialysis
- chronic kidney disease
- healthcare
- prognostic factors
- ankylosing spondylitis
- type diabetes
- emergency department
- metabolic syndrome
- mass spectrometry
- clinical trial
- adipose tissue
- bariatric surgery
- high resolution
- weight loss
- patient reported outcomes
- liquid chromatography
- randomized controlled trial
- photodynamic therapy
- patient safety
- combination therapy
- juvenile idiopathic arthritis
- placebo controlled
- weight gain
- insulin resistance
- systemic sclerosis
- study protocol