Low dose dexamethasone in newly diagnosed sarcoidosis

Sarcoidosis is a rare disease that leads to a significantly reduced quality of
life and productivity loss in young adults. There is inflammatory activity in
multiple organs, often the lungs. There is no curative therapy, but symptoms
can be suppressed with anti-inflammatory drugs. However, 90% of patients
receive in the first months after diagnosis no therapy. These patients have a
high degree of inflammatory activity and debilitating symptoms of fatigue,
malaise and pain

This study examines whether early treatment at low cost leads to relief of
symptoms, increase in quality of life, reduced health care costs and increased
work productivity. The results will contribute to new guidelines.

The main objective of this intervention study is to assess the effects of
low-dose dexamethasone therapy on the quality of life of newly diagnosed
sarcoidosis patients

The secondary objectives are to assess the effects of low-dose dexamethasone
therapy on (1) the total medical costs and work productivity of this
population, (2) depression, fatigue and sleep quality, (3) the inflammatory
profile and (4) disease progression and the need for additional pharmacotherapy

Prospective, randomized, double-blind, placebo controlled intervention study.

Patients will be assigned to either 1 mg dexamethasone once daily for 180 days,
or placebo once daily for 180 days.

Participation in this study requires per patient one additional hospital visit
and one additional vena puncture and blood sample during that visit; all
further visits and vena punctures are in conformance with standard sarcoidosis
care. During these standard hospital visits one additional blood sample will be
taken for this study (no additional vena puncture).

Patients participating in this study will be required to complete 6
questionnaires every 3 months during the first year of the study, and 6
questionnaires every 6 months during the second year of the study.

The intervention consists of once daily oral dexamethasone 1 mg or placebo
during 180 days. A dose of 1 mg dexamethasone corresponds to a prednisone
equivalent of 6.5 mg. There is substantial evidence that this dose can be
safely administered during 6 months, without significant risk of bone-related,
gastro-intestinal, cardiovascular or psychiatric adverse events.
If the present study shows that low dose dexamethasone in early sarcoidosis can
improve quality of life in the first months after diagnosis this could have a
large impact on the individual, social, and economic consequences of this
disease.