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ORIGINAL ARTICLE
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Factors predicting early discontinuation of methotrexate as a first-line treatment for rheumatoid arthritis in Italy: Results from the GISEA registry


1 Department of Medicine, Rheumatology Unit, Policlinico Hospital of Modena, University of Modena and Reggio Emilia, Modena, Italy
2 Department of Medicine, Rheumatology Unit, University of Bari, Bari, Italy
3 Department of Medicine, Rheumatology Unit, Catholic University of the Sacred Heart, Rome, Italy
4 Department of Medicine, Rheumatology Unit, Clinical and Experimental Medicine, Sant'Anna Hospital, University of Ferrara, Ferrara, Italy
5 Department of Rheumatology, Orthopedic Institute Gaetano Pini, Milan, Italy
6 Department of Medicine, Rheumatology and Clinical Immunology Unit, Spedali Civili Di Brescia, Brescia, Italy
7 Department of Clinical and Molecular Sciences, Rheumatology Unit, Università Politecnica Delle Marche, Jesi, Italy
8 Department of Medicine, Rheumatology Unit, Città della Salute e della Scienza Hospital, Turin, Italy
9 Department of Medicine, Rheumatology Unit, A.O.U. Policlinico Vittorio Emanuele, Catania, Italy
10 Department of Medicine, Rheumatology Unit, University of Siena, Siena, Italy
11 Department of Medicine, Rheumatology Unit, IRCCS Policlinico San Matteo, University of Pavia, Pavia, Italy
12 Department of Medical Sciences, Rheumatology Unit, Policlinico of the University of Cagliari, Cagliari, Italy
13 Department of Medical and Surgical Sciences, Rheumatology Clinic, University of Foggia Medical School, Foggia, Italy
14 Department of Medicine, Rheumatology Unit, University of Verona, Verona, Italy
15 Department of Internal Medicine, Sapienza University of Rome, Rome, Italy
16 Department of Medicine, Rheumatology Unit, “San Carlo” Hospital of Potenza and “Madonna delle Grazie” Hospital of Matera, Potenza, Italy
17 Department of Medicine, Rheumatology Unit, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy
18 Department of Medicine, Rheumatology Unit, University of Padua, Padova, Italy

Correspondence Address:
Andreina Manfredi,
Rheumatology Unit, Policlinico Hospital of Modena, University of Modena and Reggio Emilia, Via Università, 4, 41124 Modena
Italy
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/injr.injr_60_19

Objective: Despite the well-established efficacy of methotrexate (MTX) in rheumatoid arthritis (RA), monotherapy is not sufficient in almost half of patients. The aim of this registry-based study was to detect possible predictive factors for the early failure of MTX as a first-line treatment in early RA patients. Materials and Methods: Five-hundred and ninety RA patients beginning MTX as the first-line treatment were included. Persistence on therapy was re-evaluated after 12 months. Baseline features of disease were evaluated by means of univariate Cox regression, and parameters significantly associated to the outcome were included in multivariate model. Results: One hundred and forty-nine patients (25.3%) failed MTX during the 1st year, for inefficacy in 43.6% and adverse events in 37.5% of cases, respectively. At univariate analysis, patients who discontinued or failed treatment showed lower mean age, higher prevalence of anti-citrullinated peptide antibodies (ACPAs), and higher number of tender/swollen joints. The dose of MTX was correlated with the efficacy and the tolerance of the drug. In particular, patients treated with 7.5 mg of MTX weekly showed a higher rate of discontinuation for inefficacy than adverse events, and the contrary was detected for higher doses. On multivariate analysis, age, ACPA, and number of tender joints were directly associated with MTX discontinuation or failure. Conclusions: More than 25% of RA patients treated with MTX as a first-line therapy failed treatment at 12 months. ACPA positivity, age, and number of tender joints were associated with early withdrawal of MTX in RA patients, while the dose of MTX was correlated to the efficacy and safety of the drug.


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    -  Sebastiani M
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