Figure 2: Clinical data.
Prednisone taper is shown for all five patients; the remainder of clinical data includes only the four patients who attempted prednisone taper. A. Prednisone was tapered according to a specified protocol, Patient 2 was lost to follow up at week 4, and Patient 5 experienced worsening neurologic sarcoidosis requiring increased prednisone and ultimately withdrawal from the study. 3 patients met the primary endpoint and tapered to ≤5 mg/day. All three tapered off prednisone during the 1-year extension; 2 completed the 1-year extension and Patient 4’s extension study is ongoing. B. Pulmonary function was stable for all patients given established 10% between-test margin of variability for spirometry measurement. *DCLO is only shown for 3 patients, as this was done at baseline and week 16. C. Saint George Respiratory Questionnaire (SGRQ) scores all improved during the trial; a clinically significant difference for SGRQ is 4 units, thus all SGRQ changes were clinically significant. D) Chest radiographs from two patients whose radiographic findings improved during the study; patient 1 had a repeat chest x-ray at week 51 (during extension) showing further improvement. FEV1: forced expiratory volume in 1 second, FVC: forced vital capacity, DLCO: diffusion capacity for carbon monoxide.