Efficacy and Tolerability of Methotrexate and Methylprednisolone in a Comparative Assessment of the Primary and Long-Term Outcomes in Patients with Pulmonary Sarcoidosis.

Volodymyr Gavrysyuk,Olesia Bychenko,Nataliia Vlasova,Nataliia Pendalchuk,Nataliia Morska,Yaroslav Dziublyk,Ievgenia Merenkova

doi:10.3390/diagnostics11071289

Abstract

Background: There is insufficient information in the literature on the comparative efficacy and tolerability of methotrexate (MTX) and methylprednisolone (MP) in patients with pulmonary sarcoidosis in assessing primary outcomes and the relapse rate. Purpose: The aim of our study was to evaluate primary and long-term outcomes of using MTX and MP in patients with pulmonary sarcoidosis. Methods: A total of 143 patients with newly diagnosed pulmonary sarcoidosis, verified by high-resolution computed tomography (CT) data, were examined. Corticosteroid (CS) therapy was used in 97 patients using MP at a dose of 0.4 mg/kg body weight for 4 weeks, followed by a dose reduction to 0.1 mg/kg by the end of the sixth month. The total duration of CS therapy was 12 months on average. Forty-six patients were treated with MTX at a dose of 10 mg/week (28) and 15 mg/week (18) per os for 6 to 12 months. The study of the relapse rate was conducted within 12 months after the CT data normalization in 60 patients after CS therapy and in 24 after MTX treatment. Results: MP treatment was successfully completed in 68 (70.1%), and MTX in 29 (60.4%) patients. In five MP patients (5.2%) and in five (10.9%) MTX, treatment was discontinued due to serious side effects. In seven (7.2%) MP patients and ten (21.7%) MTX patients, treatment required additional therapy due to the lack of efficacy. Progression with MP treatment (17–17.5%) was more common than with MTX (2–4.3%; Chi square = 4.703, p = 0.031). Relapses after MP therapy were observed in 26 (43.3%) patients, and after MTX therapy in 2 (8.3%; Chi square = 9.450, p = 0.003). Conclusion: In patients with pulmonary sarcoidosis, MTX monotherapy does not differ significantly from MP monotherapy in terms of the level of efficacy and the rate of serious side effects. Increasing the MTX dose from 10 to 15 mg/week accelerates the rate of regression of sarcoidosis, improves treatment efficacy, and does not affect the rate of serious side effects. When using MTX, there is a significant decrease in the incidence of treatment resistance and the relapse rate.

Highlights

Sarcoidosis is a multisystemic disease of unknown nature, characterized by the formation of noncaseating epithelioid cell granulomas in the affected organs [1,2,3]
The diagnosis of pulmonary sarcoidosis was verified by high resolution computed tomography (CT) using the criteria described by Veltkamp M., Grutters J
During the initial stage of the study, we conducted a comparative analysis of the baseline clinical symptoms of the patients (Table 1)

Summary

Introduction

Sarcoidosis is a multisystemic disease of unknown nature, characterized by the formation of noncaseating epithelioid cell granulomas in the affected organs [1,2,3].Usually, sarcoidosis affects young and middle-aged people. If there are indications for systemic pharmacotherapy (dyspnea, cough, pulmonary function impairment, involvement of the heart, nervous system, eyes, hypercalcemia, as well as all cases of disease progression [1,8,9]), first-line agent corticosteroids (CS) are prescribed [1,8,10,11]. Their efficacy in assessing the immediate results has been proven in randomized trials [12,13]. Results: MP treatment was successfully completed in 68 (70.1%), and MTX in 29 (60.4%)

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