Efficacy and safety of methylprednisolone pulse followed by oral prednisone vs. oral prednisone alone in sarcoidosis tubulointerstitial nephritis: a randomized, open-label, controlled clinical trial

• Published in: Nephrology, dialysis, transplantation dialysis, transplantation, 2023-03, Vol.38 (4), p.961-968
• Main Authors: Mahevas, Matthieu, Audard, Vincent, Rousseau, Alexandra, Cez, Alexandre, Guerrot, Dominique, Verhelst, David, Delahousse, Michel, Hanrotel, Catherine, Pillebout, Evangeline, Daugas, Eric, Krastinova, Evguenia, Valeyre, Dominique, Boffa, Jean-Jacques
• Format: Article
• Language: English
• Subjects: Human health and pathology; Humans; Life Sciences; Methylprednisolone - adverse effects; Nephritis, Interstitial - drug therapy; Nephritis, Interstitial - epidemiology; Prednisone - adverse effects; Prospective Studies; Sarcoidosis - chemically induced; Sarcoidosis - drug therapy; Treatment Outcome; Urology and Nephrology
• ISSN: 0931-0509; 1460-2385
• DOI: 10.1093/ndt/gfac227

ABSTRACT Background We determine the benefit of pulsed methylprednisolone for improving kidney function in patients with sarcoidosis tubulointerstitial nephritis. Methods We conducted a multicenter, prospective, randomized, open-label, controlled trial in patients with biopsy-proven acute tubulointerstitial nephritis caused by sarcoidosis at 21 sites in France. Patients were randomly assigned to receive a methylprednisolone pulse 15 mg/kg/day for 3 days, then oral prednisone (MP group) or oral prednisone 1 mg/kg/day alone (PRD group). The primary end point was a positive response at 3 months, defined as a doubling of estimated glomerular filtration rate (eGFR) compared with the eGFR before randomization. Results We randomized 40 participants. Baseline eGFR before PRD was 22 mL/min/1.73m2 {interquartile range [IQR], 16–44} and before MP was 25 mL/min/1.73m2 (IQR, 22–36) (P = .3). The two groups did not differ in underlying pathological lesions, including mean percentage of interstitial fibrosis and intensity of interstitial infiltrate. In the intent-to-treat population, the median eGFR at 3 months did not significantly differ between the PRD and MP groups: 45 (IQR, 34–74) and 46 (IQR, 39–65) mL/min/1.73m2. The primary end point at 3 months was achieved in 16 of 20 (80%) PRD patients and 10 of 20 (50%) MP patients (P = .0467). The eGFR was similar between the two groups after 1, 3, 6, and 12 months of treatment. For both groups, eGFR at 1 month was strongly correlated with eGFR at 12 months (P