Efficacy, safety outcomes similar with high, low prednisolone dose for sarcoidosis

Key takeaways:

• Relapse/treatment failure rates did not differ between a low and high dose of prednisolone.
• The higher dose did not yield significant improvements in health-related quality-of-life scores.

Patients with sarcoidosis receiving 40 mg per day of prednisolone had comparable rates of treatment failure and adverse effects to patients receiving 20 mg per day, according to a European Respiratory Society International Congress presentation.

“The [World Association of Sarcoidosis and other Granulomatous Disorders] guideline of 1999, which remained the only guiding document for almost 2 decades, and the recent [British Thoracic Society] 2021 statements say that we should use 20 to 40 mg [per day] as the initial dose of prednisolone for treating sarcoidosis, while the [European Respiratory Society] 2021 statement suggests that we should use only the 20 mg per day dose as the initiating therapy in most patients with sarcoidosis,” Sahajal Dhooria, MD, DM, associate professor in the department of pulmonary medicine at Postgraduate Institute of Medical Education and Research in Chandigarh, India, said during the presentation.

In a single center, open-label, parallel group, randomized controlled trial (SARCORT), Dhooria and colleagues analyzed 42 patients with sarcoidosis initially treated with high-dose prednisolone (40 mg/day) and 43 patients initially treated with low-dose prednisolone (20 mg/day) to compare rates of relapse/treatment failure between the two groups at 18 months.

Researchers also looked for differences in time to relapse, overall response, lung function (FVC) at 6 and 18 months, treatment-related adverse effects and health-related quality-of-life scores (Sarcoidosis Health Questionnaire and Fatigue Assessment Scale).

Over 6 months, the dose of daily prednisolone was gradually reduced in both sets of patients. Patients receiving the higher dose began with 40 mg daily for 4 weeks, followed by 30 mg, 20 mg, 15 mg, 10 mg and 5 mg daily each for 4 weeks, Dhooria said. Patients in the lower dose group received 20 mg and 15 mg daily for 8 weeks and then 10 mg and 5 mg daily for 4 weeks.

During the last 2 weeks, researchers gave patients in both groups 5 mg of prednisolone on alternate days.

Of the total cohort, 37 patients (86%) receiving the high-dose and 41 patients (95.3%) receiving the lower dose attended the follow-up visit at 18 months.

Researchers did not find a significant difference in the rate of relapse between the high-dose and low-dose groups (46.5% vs. 44.2%). Time to relapse/treatment failure also appeared comparable, with a mean time of 307 days in the high-dose group and a mean time of 269 days in the low-dose group.

Other outcomes, including overall response (resolution, improvement, stabilization and worsening), changes in FVC and the prevalence of adverse effects related to the treatment, did not differ between the two doses of prednisolone, according to Dhooria.

Researchers also found comparable changes in health-related quality-of-life scores among both sets of patients.

“High-dose prednisolone was not found to be superior to a lower dose in improving outcomes or the health-related quality of life in sarcoidosis and was associated with similar adverse effects,” Dhooria said during the presentation.