In this study, the efficacy and safety of treating pulmonary sarcoidosis with 12 months vs. 6 months of prednisolone will be compared. The hypothesis is that longer treatment DURAtion would be more effective in preventing treatment failure or early relapse in SARCoidosis (DURASARC trial). The premise of this hypothesis is that even small doses of prednisolone given over longer periods can effectively suppress disease activity in sarcoidosis without a significant increase in adverse effects.
Age between 18 and 65 years
Computed tomography of the chest consistent with a diagnosis of sarcoidosis of the lung/mediastinal lymph nodes
Diagnosis of sarcoidosis made on cytological or histological samples
Having significant symptoms requiring immunosuppressive treatment and/or having reduced lung function (defined as forced vital capacity or forced expiratory volume in one second (FEV1) less than 80% predicted) or an extrapulmonary manifestation of the disease requiring treatment with low-medium dose glucocorticoids
Pregnant or lactating women
Subjects having any manifestation requiring high dose steroid treatment (this includes symptomatic neurosarcoidosis, life threatening cardiac sarcoidosis, vision threatening posterior uveitis or other forms of vision threatening ocular sarcoidosis)
Having absolute contraindication for prednisone (this includes untreated glaucoma, uncontrolled diabetes mellitus, untreated infections, untreated severe psychiatric disorders)
Unwilling to participate in the study
Parallel
Prednisolone
DrugAn initial dose of 40 mg/day will be administered for 1 week, followed by 30 mg/day for 1 week, 20 mg/day for 6 weeks, 15 mg/day for 4 weeks, 10 mg/day for 8 weeks, 5 mg/day for 4 weeks, 2.5 mg/day for 2 weeks after which the drug will be discontinued (cumulative prednisolone dose, 2485 mg).
Prednisolone
DrugAn initial dose of 40 mg/day will be administered for 1 week, followed by 30 mg/day for 1 week, 20 mg/day for 6 weeks, 15 mg/day for 4 weeks, 10 mg/day for 14 weeks, 5 mg/day for 24 weeks, 2.5 mg/day for 2 weeks after which the drug will be discontinued (cumulative prednisolone dose, 3605 mg).
Relapse or treatment failure
Proportion of subjects with a relapse (worsening after 4 weeks of stopping treatment) or treatment failure (worsening during treatment or within 4 weeks of stopping treatment requiring an increase in the treatment intensity) in the study groups. Worsening is defined as persistent (≥2 weeks) worsening of cough and/or dyspnea, and one or more of the following: a) worsening of lung function (≥5-point reduction in percentage-predicted FVC or FEV1), or b) increase in the chest radiograph abnormalities due to sarcoidosis.
Treatment response
Proportion of subjects with good or fair treatment response between the study groups defined as: Good response: Resolution (no symptoms attributable to sarcoidosis, a normal chest radiograph, and normal lung function with normal laboratory parameters related to the initial treatment-requiring indication) or improvement (improvement in respiratory symptoms with either (a) decrease in radiological abnormalities, or (b) a ≥5-point increase in the percentage-predicted FVC or FEV1 from the baseline, or (c) both, with no worsening on imaging or spirometry along with normal/stable laboratory parameters related to the initial treatment-requiring indication) with treatment. Fair response: Stabilization (any reduction in symptoms along with stable radiological abnormalities, and less than a 5-point change in the percentage-predicted FVC and FEV1 along with normal/stable lab parameters) of disease during treatment.
Sarcoidosis health related quality of life
Sarcoidosis health related quality of life will be assessed using the King's Sarcoidosis Questionnaire (KSQ). KSQ is a validated multidomain instrument used to assess QoL of patients with sarcoidosis. The domains include: general health (GH), lung, medication, skin and eyes. The questionnaire consists of 29 items (general health: 10, lung: 6, medication: 3, skin: 3, eyes: 7) that assess the disability that the symptoms in various domains have posed on the patient's day-to-day activities in the past week. Each item is rated on a 7-point Likert scale from 1 (all of the time) to 7 (none of the time). The KSQ module and overall (total) scores are finally transformed to a range of 0-100 \[(actual score - lowest possible score/range) ×100\], where higher scores represent better health status. A minimal clinically important difference (MCID) of 8 for the KSQ GH and of 4 for the KSQ lung have been proposed in a study of 271 subjects.
Forced vital capacity
Mean change in forced vital capacity assessed using spirometry between the study groups. Spirometry will be performed according to the ATS/ERS guidelines using an ultrasonic flow sensor spirometer (NDD Medizintechnik AG, Zurich, Switzerland) and will be expressed in liters.
Adverse effects
Proportion of subjects having glucocorticoid-related adverse effects will be recorded including weight gain, Cushingoid features, infections, skin thinning, ecchymosis, cataracts, increased intraocular pressure, hypertension, gastritis, osteoporosis, myopathy, mood disorder, psychosis, memory impairment, hyperglycemia, and others.
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