Chest
Volume 121, Issue 1, January 2002, Pages 24-31
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Clinical Investigations
Sarcoid
Early Treatment of Stage II Sarcoidosis Improves 5-Year Pulmonary Function

https://doi.org/10.1378/chest.121.1.24Get rights and content

Study objective

To evaluate the 5-year prognosis ofpatients with stage I and stage II newly detected (< 3 months)pulmonary sarcoidosis treated immediately after diagnosis withprednisolone for 3 months followed by inhaled budesonide for 15months.

Design

Randomized, double-blind,placebo-controlled, parallel-group study for 18 months. Thereafter,open follow-up without treatment.

Setting

Twentypulmonary medicine departments in Finland.

Patients

One hundred eighty-nine adult patients, most of them with normal lungfunction, were randomized to treatment. One hundred forty-nine patientswere followed up for 5 years: 79 patients with initial stage I diseaseand 70 patients with stage II disease.

Treatment

Oralprednisolone for 3 months followed by inhaled budesonide for 15 months(800 μg bid), or placebo tablets followed by placebo inhaler therapy.Thereafter, treatment only on an individual basis in the case ofclinical deterioration.

Measurements

Yearly follow-upvisits with chest radiographs, lung function tests (FEV1,FVC), diffusion capacity of the lung for carbon monoxide(Dlco), serum angiotensin-converting enzyme (SACE), andserum and urinary calcium measurements.

Results

Noinitial differences were observed in chest radiographic findingsbetween the active-treatment and placebo-treatment groups, either inpatients with initial stage I or stage II(-III) disease. However, afterthe 5-year follow-up, 18 steroid-treated patients (26%) and 30placebo-treated patients (38%) still had remaining chest radiographicchanges. Placebo-treated patients more frequently required treatmentwith corticosteroids during the 5-year follow-up (p < 0.05).Steroid-treated patients with initial stage II(-III) disease improvedmore in FVC and Dlco (p < 0.05). No differences inreported adverse events or in SACE, serum calcium, or urinary calciumvalues were seen.

Conclusion

Immediate treatment ofpulmonary stage II(-III) sarcoidosis—but not stage I disease—improvedthe 5-year prognosis with regard to lung functionvariables.

Section snippets

Study Design

The 18-month treatment phase was a randomized,placebo-controlled, double-blind, parallel-group, multicenter study aspreviously described.5 The 5-year follow-up study was anopen-label study extension.

Patients

The 18-month treatment phase included 189 randomized patients ofboth genders and ≥ 18 years old. They had newly detected (diagnosedwithin 3 months from the first symptoms or signs) radiographic stage Idisease (bilateral hilar lymphadenopathy; n = 94) or stage II disease(parenchymal infiltrates with

Results

Of the initial 189 randomized patients, 35 patients (16steroid-treated and 19 placebo-treated) did not complete the 18-monthtreatment phase as previously reported.5 Of the 154remaining patients, 149 patients participated in the follow-up part ofthe study. Five patients refused to take part in the follow-up. Figure 1 shows the initial randomization to treatment with corticosteroids orplacebo, separately for patients with stage I and stage II(-III)pulmonary radiographic findings. The number of

Discussion

Corticosteroids are considered to be beneficial in the treatmentof pulmonary sarcoidosis, as their administration usually results inrelief of respiratory symptoms and improvements in lung function andchest radiographic findings.8 Results of controlledclinical studies also show that both systemic9 andinhaled1011 corticosteroid treatment influence cellularand biochemical findings, which appear to be important in theimmunopathogenesis of the disease. However, reappearance of symptomsand

Appendix

In addition to the authors, the following investigators andhospitals were members of the Finnish Study Group on PulmonarySarcoidosis, and participated in the study: Etelaï-Karjala CentralHospital (R. Kauppinen), Etelaï-Pohjanmaa Central Hospital (M.Koskenkari, E. Kokko, L. Tuomisto), Haïrmaï Hospital (E.Aalto), Kanta-Haïme Central Hospital (M. Jaïrvinen),Keski-Pohjanmaa Central Hospital (R. Lillqvist, J-H. Slotte), KiljavaHospital (R. Tammivaara, S. Koskinen), Kuopio University Hospital

ACKNOWLEDGMENT

The authors thank Eeva-Leena Franicevic, RN,Meltola Hospital, and later at AstraZeneca, Finland, for monitoring thestudy.

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    Financial support was provided by AstraZeneca, R&D, Lund, Sweden, andAstraZeneca, Finland.

    Dr. Persson is a full-time statistician employed by AstraZenecaR&D, Lund, Sweden.

    Dr. Selroos, who initiated the study while working asPhysician-in-Chief at Meltola Hospital, Finland, has been appointed amedical advisor to AstraZeneca, R&D, Lund, Sweden.

    A complete list of the members of the Finnish Sarcoidosis Study groupis given in the Appendix.

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