open access

Vol 82, No 6 (2014)
ORIGINAL PAPERS
Submitted: 2014-10-22
Accepted: 2014-10-22
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Methotrexate as a single agent for treating pulmonary sarcoidosis: a single centre real-life prospective study

Anna Goljan-Geremek, Michał Bednarek, Monika Franczuk, Elżbieta Puścińska, Adam Nowiński, Monika Czystowska, Dariusz Kamiński, Damian Korzybski, Anna Stokłosa, Anna Kowalska, Emil Wojda, Paweł Śliwiński, Barbara Burakowska, Jakub Ptak, Inga Barańska, Alicja Drygalska, Grzegorz Małek, Iwona Bestry, Stefan Wesołowski, Marek Kram, Dorota Górecka
DOI: 10.5603/PiAP.2014.0069
·
Pneumonol Alergol Pol 2014;82(6):518-533.

open access

Vol 82, No 6 (2014)
ORIGINAL PAPERS
Submitted: 2014-10-22
Accepted: 2014-10-22

Abstract

Introduction: The first-line therapy in chronic sarcoidosis, according to WASOG/ATS/ERS recommendations, is GCS. This therapy is associated with significant adverse effects and finally does not alter the natural history of the disease. The objective of our study was to evaluate the efficacy and safety of monotherapy with MTX, as an alternative to GCS, in progressive pulmonary sarcoidosis.

Material and methods: An open prospective real-life, single-centre trial was performed on 50 patients with biopsy proven sarcoidosis, 28M and 22F, mean age 45.55 ± 8.9 years. The average duration of disease before MTX therapy was 12.34 ± 20.49 years, GCS therapy in the past was applied in 41 patients. All patients received MTX (10 mg or 15 mg weekly) between 2004 and 2013 because of chronic progressive pulmonary sarcoidosis. Therapy was planned for 24 months. Patients underwent regular clinical evaluation, pulmonary function assessment, exercise ability testing (6MWT), and chest radiography for therapy effectiveness every six months and side effects monitoring every 4–6 weeks. Forty-nine patients were included for statistical analysis of treatment efficacy. They were retrospectively allocated to “MTX responder” group if an improvement of 10% of FEV1, FVC, TLC, or 15% of DLCO from the initial value was documented for at least one parameter or “non-responders” if the patient did not meet the above-mentioned criteria.

Results: Duration of treatment ranged from 6 to 24 months, mean time 60.75 ± 34.1 weeks. For the whole cohort significant improvement after MTX therapy was observed for minimal SaO2 (%) (p = 0.043) and for decrease of DSaO2 (%) (p = 0.048) in six-minute walk test. The results were significantly better for patients treated with 15 mg than for those treated with 10 mg weekly and for those who obtained a greater total amount of MTX during therapy. Significant difference of DLCO%pred was observed after six months of MTX therapy between groups treated 15 mg vs 10 mg weekly (73.27 ± 12.7% vs. 63.15 ± 16.4%, p = 0.03). Twenty-five patients (55%) met the criteria of “MTX responders” group. Patients who responded well to treatment had significantly lower TLC and FVC initial values comparing to “MTX non-responders”. After treatment the only significant difference in PFT between groups was noted for DLCO%pred. Eleven patients (22%) stopped the treatment due to adverse events of MTX, mild hepatic abnormalities were observed in ten patients (20%), and concomitant infection was found in four patients. There were no patients with a fatal outcome.

Conclusions: MTX as a single agent in the treatment of sarcoidosis has proved to be a safe and effective steroid alternative. Selected patients with chronic pulmonary sarcoidosis experience definite PFT improvements after MTX treatment. There is need to search for predictors of MTX treatment effectiveness.

Abstract

Introduction: The first-line therapy in chronic sarcoidosis, according to WASOG/ATS/ERS recommendations, is GCS. This therapy is associated with significant adverse effects and finally does not alter the natural history of the disease. The objective of our study was to evaluate the efficacy and safety of monotherapy with MTX, as an alternative to GCS, in progressive pulmonary sarcoidosis.

Material and methods: An open prospective real-life, single-centre trial was performed on 50 patients with biopsy proven sarcoidosis, 28M and 22F, mean age 45.55 ± 8.9 years. The average duration of disease before MTX therapy was 12.34 ± 20.49 years, GCS therapy in the past was applied in 41 patients. All patients received MTX (10 mg or 15 mg weekly) between 2004 and 2013 because of chronic progressive pulmonary sarcoidosis. Therapy was planned for 24 months. Patients underwent regular clinical evaluation, pulmonary function assessment, exercise ability testing (6MWT), and chest radiography for therapy effectiveness every six months and side effects monitoring every 4–6 weeks. Forty-nine patients were included for statistical analysis of treatment efficacy. They were retrospectively allocated to “MTX responder” group if an improvement of 10% of FEV1, FVC, TLC, or 15% of DLCO from the initial value was documented for at least one parameter or “non-responders” if the patient did not meet the above-mentioned criteria.

Results: Duration of treatment ranged from 6 to 24 months, mean time 60.75 ± 34.1 weeks. For the whole cohort significant improvement after MTX therapy was observed for minimal SaO2 (%) (p = 0.043) and for decrease of DSaO2 (%) (p = 0.048) in six-minute walk test. The results were significantly better for patients treated with 15 mg than for those treated with 10 mg weekly and for those who obtained a greater total amount of MTX during therapy. Significant difference of DLCO%pred was observed after six months of MTX therapy between groups treated 15 mg vs 10 mg weekly (73.27 ± 12.7% vs. 63.15 ± 16.4%, p = 0.03). Twenty-five patients (55%) met the criteria of “MTX responders” group. Patients who responded well to treatment had significantly lower TLC and FVC initial values comparing to “MTX non-responders”. After treatment the only significant difference in PFT between groups was noted for DLCO%pred. Eleven patients (22%) stopped the treatment due to adverse events of MTX, mild hepatic abnormalities were observed in ten patients (20%), and concomitant infection was found in four patients. There were no patients with a fatal outcome.

Conclusions: MTX as a single agent in the treatment of sarcoidosis has proved to be a safe and effective steroid alternative. Selected patients with chronic pulmonary sarcoidosis experience definite PFT improvements after MTX treatment. There is need to search for predictors of MTX treatment effectiveness.

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Keywords

methotrexate, sarcoidosis, PFT, treatment

About this article
Title

Methotrexate as a single agent for treating pulmonary sarcoidosis: a single centre real-life prospective study

Journal

Advances in Respiratory Medicine

Issue

Vol 82, No 6 (2014)

Pages

518-533

DOI

10.5603/PiAP.2014.0069

Bibliographic record

Pneumonol Alergol Pol 2014;82(6):518-533.

Keywords

methotrexate
sarcoidosis
PFT
treatment

Authors

Anna Goljan-Geremek
Michał Bednarek
Monika Franczuk
Elżbieta Puścińska
Adam Nowiński
Monika Czystowska
Dariusz Kamiński
Damian Korzybski
Anna Stokłosa
Anna Kowalska
Emil Wojda
Paweł Śliwiński
Barbara Burakowska
Jakub Ptak
Inga Barańska
Alicja Drygalska
Grzegorz Małek
Iwona Bestry
Stefan Wesołowski
Marek Kram
Dorota Górecka

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