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Dosing and duration of glucocorticoid therapy for adult patients with IgA nephropathy

Dosing and duration of glucocorticoid therapy for adult patients with IgA nephropathy
Glucocorticoid Initial dose Duration of initial dose Taper Total duration of glucocorticoid therapy* Reference

Methylprednisolone (IV)

and

Prednisolone/prednisone (oral)

Methylprednisolone 1 g IV for 3 days at the start of months 1, 3, and 5

and

Prednisolone or prednisone 0.5 mg/kg orally every other day on remaining days		 6 months None 6 months

Pozzi et al 1999[1]
(86 patients)

Rauen et al 2015[2]
(109 patients)
Prednisone 1 mg/kg orally per day (maximum dose: 75 mg/day) 2 months Reduce daily dose by 0.2 mg/kg every month for 4 months 6 months Manno et al 2009[3]
(97 patients)
Prednisone 0.8 to 1 mg/kg orally per day 2 months Reduce daily dose by 5 to 10 mg every 2 weeks for ≥4 months 6 to 8 months Lv et al 2009[4]
(63 patients)
Methylprednisolone 0.4 mg/kg orally once daily (rounded to nearest 4 mg; maximum dose: 32 mg/day) 2 months Reduce daily dose by 4 mg every month for ≥4 months 6 to 9 months TESTING 2022[5,6]
(241 patients)
Targeted-release formulation of budesonide (TRF-budesonide)Δ◊ 16 mg orally daily 9 months Reduce dose to 8 mg once daily for 2 weeks, then discontinue 9 months and 2 weeks

Barratt et al 2023[7]
(199 patients)

Lafayette et al 2023[8,9]
(364 patients)
This table describes glucocorticoid regimens used for IgA nephropathy in various clinical trials, listed in chronological order by trial. For further discussion on treatment, including patient selection and strategies for minimizing toxicity and prevention of Pneumocystis jirovecii pneumonia infection, refer to the UpToDate clinical topic review of treatment of IgA nephropathy.

IgA: immunoglobulin A; IV: intravenously.

* Although the total duration of conventional release glucocorticoid therapy in clinical trials ranged from 6 to 9 months, UpToDate contributors aim for a total duration of 6 months, administered as an initial dose for 2 months followed by tapered doses for 4 months, individualized according to response; refer to topic discussion.

¶ Only the reduced dose of methylprednisolone from the TESTING trial is reported here since the higher dose that was initially used in the trial was discontinued for safety reasons.

Δ TRF-budesonide is an oral targeted-release formulation of the glucocorticoid budesonide that has been designed to release the drug in the distal ileum, where most Peyer patches are located. TRF-budesonide is reported to have a 90% hepatic conversion to metabolites with minimal glucocorticoid activity at first liver passage, limiting its systemic bioavailability.

◊ Some UpToDate contributors use TRF-budesonide as initial immunosuppressive therapy in patients with IgA nephropathy in whom systemic glucocorticoids are contraindicated or who do not wish to take systemic glucocorticoids. Other UpToDate contributors would reserve this agent for patients who do not respond to or cannot tolerate a 6-month course of moderate-dose oral systemic glucocorticoids and who have a persistent urine protein-to-creatinine ratio ≥1.5 g/g or proteinuria ≥2 g/day.
References:
  1. Pozzi C, Bolasco PG, Fogazzi GB, et al. Corticosteroids in IgA nephropathy: A randomised controlled trial. Lancet 1999; 353:883.
  2. Rauen T, Eitner F, Fitzner C, et al. Intensive supportive care plus immunosuppression in IgA nephropathy. N Engl J Med 2015; 373:2225.
  3. Manno C, Torres DD, Rossini M, et al. Randomized controlled clinical trial of corticosteroids plus ACE-inhibitors with long-term follow-up in proteinuric IgA nephropathy. Nephrol Dial Transplant 2009; 24:3694.
  4. Lv J, Zhang H, Chen Y, et al. Combination therapy of prednisone and ACE inhibitor versus ACE-inhibitor therapy alone in patients with IgA nephropathy: A randomized controlled trial. Am J Kidney Dis 2009; 53:26.
  5. Lv J, Wong MG, Hladunewich MA, et al. Effect of oral methylprednisolone on decline in kidney function or kidney failure in patients with IgA nephropathy: The TESTING randomized clinical trial. JAMA 2022; 327:1888.
  6. Lv J, Zhang H, Wong MG, et al. Effect of oral methylprednisolone on clinical outcomes in patients with IgA nephropathy: The TESTING randomized clinical trial. JAMA 2017; 318:432.
  7. Barratt J, Lafayette R, Kristensen J, et al. Results from part A of the multi-center, double-blind, randomized, placebo-controlled NefIgArd trial, which evaluated targeted-release formulation of budesonide for the treatment of primary immunoglobulin A nephropathy. Kidney Int 2023; 103:391.
  8. Lafayette R, Kristensen J, Stone A, et al. Efficacy and safety of a targeted-release formulation of budesonide in patients with primary IgA nephropathy (NefIgArd): 2-year results from a randomised phase 3 trial. Lancet 2023; 402:859.
  9. TARPEYO [package insert]. Stockholm, Sweden: Calliditas Therapeutics AB; 2021. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215935s000lbl.pdf (Accessed on May 1, 2023).
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