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Methotrexate alone and methotrexate combined with etanercept in treatment of rheumatoid arthritis


The aim of this study is to evaluate the efficacy and safety of methotrexate (MTX) alone and combined therapy of Etanercept (ETN) and methotrexate (MTX), in patients with rheumatoid arthritis (RA).


Patients with RA were treated in combination with ETN (with doses of 25 mg subcutaneously twice weekly), with oral MTX (doses up to 20 mg weekly), and alone MTX (doses up to 20 mg weekly) in period of two years, in Rheumatology Department of Internal Clinic in Prishtina. Clinical response was assessed using American College of Rheumatology (ACR) criteria and the Disease Activity Score (DAS28) in 60 patients with RA. Radiographic changes were measured in the beginning and at the end of the study with Sharp Score.


Of total number of 60 patients (10 of them were males and 50 were females) with mean age of 57.63, 10 or 16.6% of patients were treated with combined therapy (ETN plus MTX) and 50 or 83.3% of patients with monotherapy (MTX). The group of combined therapy (ETN+MTX) after the treatment resulted with improvement of acute phase reactants as erythrocyte sedimentation rate (ESR) for the first hour (41.1 vs. 10.3 mm/hour) and C-reactive protein (CRP) (40.8 vs. 6 mg/liter) comparing to the group treated with MTX alone there were no significant changes (ESR: 45.7 vs. 34.3 mm/hour; CRP: 48 vs. 24 mg/liter). Before treatment the severity of the disease was high, where in group with combined therapy (ETN plus MTX) DAS28 was 5.32, and in the group with monotherapy of MTX DAS28 was 5.90. After 2 years of treatment we had significant changes in the results of DAS28, where in group treated with ETN plus MTX DAS28 was 2.12 ± 0.15, while in the group of patients treated with MTX DAS28 were 3.75 ± 0.39 (t = 13.03; df = 58; p < 0.0001). The group with combined therapy showed less radiographic progression comparing to the group of monotherapy (p < 0.05).


According to our results we can conclude that ETN in combination with MTX reduced disease activity, slowed radiographic progression and improved clinical manifestations more effectively than MTX alone within period of 2 years. During the treatment, no serious adverse events were noticed with combination treatment of ETN and MTX.


  1. 1.

    Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS: The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum. 1988, 31: 315-324. 10.1002/art.1780310302.

  2. 2.

    Matsumoto AK, Bathon J, Bingham III CO: Rheumatoid arthritis treatment. Available from Johns Hopkins Arthritis Center. []

  3. 3.

    Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al: American College of Rheumatology preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995, 38: 727-35. 10.1002/art.1780380602.

  4. 4.

    Prevoo ML, van 't Hof MA, Kuper HH, van Leeuwen MA, van de Putte LB, van Riel PL: Modified disease activity scores that include twenty-eight-joint counts: development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum. 1995, 38: 44-8. 10.1002/art.1780380107.

  5. 5.

    Pincus T, Sokka T, Wolfe F: Premature mortality in patients with rheumatoid arthritis: evolving concepts. Arthritis Rheum. 2001, 44: 1234-6. 10.1002/1529-0131(200106)44:6<1234::AID-ART213>3.0.CO;2-R.

  6. 6.

    Bathon JM, Martin RW, et al: A comparison treatment of etanercept and methotrexate in patients with early rheumatoid arthritis. N Engl J Med. 2000, 343: 1586-93. 10.1056/NEJM200011303432201.

  7. 7.

    Weinblatt ME, Kreer JM, Bankhurst AS: A trial of etanercept, a recombinant tumor necrosis factor receptor: Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate. N Engl J Med. 1999, 340 (4): 253-9. 10.1056/NEJM199901283400401. The first DBPCS (89 patients) with etanercept which showed the efficacy of etanercept when used as combination treatment with methtrexate over 6 months of treatment

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Correspondence to Sylejman Rexhepi.

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Rexhepi, S., Rexhepi, M., Rexhepi, B. et al. Methotrexate alone and methotrexate combined with etanercept in treatment of rheumatoid arthritis. Arthritis Res Ther 14, P60 (2012) doi:10.1186/ar3661

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  • Rheumatoid Arthritis
  • Methotrexate
  • Erythrocyte Sedimentation Rate
  • Acute Phase
  • Etanercept