Long-term methotrexate use in rheumatoid arthritis patients: real-world data from the MARTE study.

BACKGROUND: The MARTE study investigated the demographic, clinical, and therapeutic characteristics of rheumatoid arthritis (RA) patients ongoing methotrexate (MTX) treatment for longer than 8 years. METHODS: This cross-sectional, observational study considered 587 RA patients from 67 Rheumatology Units across Italy. Data collected included demographic, clinical, and therapeutic characteristics, focusing on MTX prescription patterns (route of administration, dosing regimens, treatment duration, and discontinuation). RESULTS: As initial therapy, 90.6% of patients received one conventional synthetic Disease Modifying Anti Rheumatic Drug (csDMARD), with treatment started within the first 3 months from diagnosis in half of the patients. MTX was the first csDMARD in 46.2% of patients. The prevalent route of administration at diagnosis was the intramuscular (60.5%), while at study entry (baseline) 57.6% were receiving subcutaneous MTX. Patients who required a higher MTX dose at study entry were those who received a significantly lower starting MTX dose (P<0.001). Significantly higher MTX doses were currently required in men (P<0.001), current smokers (P=0.013), and overweight patients (P=0.028), whereas patients on oral therapy received significantly lower doses of MTX (P<0.001). CONCLUSIONS: The MARTE study confirms once again the potential of the proper use of MTX in the treatment of RA. Data from our study suggest that a higher dose of MTX should be used since the first stages in overweight patients, men, and smokers.

Adherence to current recommendations on the use of methotrexate in rheumatoid arthritis in Italy: results from the MARI study.

OBJECTIVES: The aim of this study was to assess how the management of rheumatoid arthritis (RA) with methotrexate (MTX) in Italy is adherent to current national recommendations. METHODS: We performed a cross-sectional and retrospective analysis of data collected from the MARI study, a multicentre survey on Italian patients with RA on treatment with MTX for at least 12 months. Retrospective data included patient's clinical history, previous treatment with MTX, screening tests performed before MTX prescription. Cross-sectional data were collected about current treatment with MTX, concomitant medications, and disease activity. Each proposition of the 2013 Italian recommendations on the use of MTX in RA was reformulated in terms of audit criteria, and adherence to provided indications was evaluated for every patient. RESULTS: Among the 1336 included patients, less than 40% had started treatment with MTX within 3-6 months from the diagnosis and nearly 30% of them were prescribed with an initial dose of MTX between 12.5 and 15 mg/week. Screening for HBV and HCV infection as well as chest x-ray was performed in a proportion of patients around 60% and more than 90% of them underwent lab tests before MTX prescription and regularly throughout the treatment. Folic acid supplementation was given at recommended dosages in a high proportion of patients. CONCLUSIONS: Our survey showed a good adherence of Italian rheumatologists to recommendations regarding safety issues with MTX in RA, but a suboptimal approach in terms of time and dosage of the treatment in the early phases of the disease.

Long-term safety and efficacy of low-dose cyclosporin A in severe psoriatic arthritis.

OBJECTIVE: The aim of this study was to evaluate the efficacy and tolerability of long-term treatment with cyclosporin A (CsA) in patients with psoriatic arthritis (PsA). METHODS: Sixty patients with PsA were enrolled in a prospective, nonrandomised study of CsA. Patients with hypertension or hypercreatinemia were excluded. Disease activity was evaluated according to clinical activity measures and the Psoriasis Area Severity Index (PASI). Assessments were made at baseline and after 3, 6, 12, 18, and 24 months. Measurements. The primary endpoints were 20% and 50% improvement in disease activity according to American College of Rheumatology (ACR) responses at 6, 12, 18, and 24 months. Other endpoints were 70% ACR responses at 6, 12, 18, and 24 months and other measures of disease activity at 3, 6, 12, 18, and 24 months. RESULTS: Forty-nine patients completed the 24-month of treatment with CsA. When all the clinical variables throughout the study were compared with baseline results, they all showed significant improvement after 6 months of treatment. Erythrocyte sedimentation rates (ESR) reached a significant improvement after 12 months of treatment (P<0.05). The PASI scores decreased from 15.1+/-4.3 to 5.2+/-2.7 after 24 months of treatment (P<0.001). Side effects included hypertrichosis (24% of patients), gum hyperplasia (12%), gastrointestinal intolerance (9%), hypertension (21%), neurological disturbance (7%), and nephrotoxicity (17%). Three patients withdrew due to treatment failure. One patient was lost to follow-up, and seven patients withdrew due to side effects. CONCLUSIONS: Cyclosporin A represents a helpful second-choice treatment for patients with active psoriatic arthritis. Administration of CsA necessitates expert and careful follow-up of patients.