PMID- 35869690
OWN - NLM
STAT- MEDLINE
DCOM- 20220916
LR  - 20221021
IS  - 1875-9114 (Electronic)
IS  - 0277-0008 (Linking)
VI  - 42
IP  - 9
DP  - 2022 Sep
TI  - Randomized controlled trial to compare safety and efficacy of mycophenolate vs. 
      cyclosporine after rituximab in children with steroid-resistant nephrotic 
      syndrome.
PG  - 690-696
LID - 10.1002/phar.2721 [doi]
AB  - OBJECTIVE: The comparative safety and efficacy of maintenance mycophenolate 
      mofetil (MMF) and cyclosporine (CYC) following rituximab (RTX) in children with 
      steroid-resistance nephrotic syndrome are uncertain. STUDY DESIGN AND SETTING: 
      Multicenter randomized controlled trial. PATIENTS: Sixty-six children between 2 
      and 6 years of age with SRNS. INTERVENTIONS: Patients were randomized to receive 
      either MMF 1000 mg/m(2) /day (n = 32) or CYC 5 mg/kg/day (n = 34) for 12 months 
      following RTX induction therapy (375 mg/m(2) ) given as needed for B-cell count. 
      MAIN OUTCOMES: Complete remission and adverse events (AEs). RESULTS: Complete 
      remission was observed in 26 patients (83.1%) in the MMF group compared with 21 
      patients (61.7%) in the CYC group (p = 0.02). The median time to remission was 
      shorter in the MMF group than in the CYC group (2.64 vs. 3.4 months; hazard ratio 
      [HR], 0.61; 95% CI, 0.74-0.90, p = 0.03). The median time to first relapse was 
      longer in the MMF group compared with the CYC group (10.8 vs. 8.0 months; HR, 
      1.12; 95% CI, 1.31-1.54, p = 0.01), and this was significantly correlated with 
      the median time to B-cell recovery in the two groups (8.6 vs. 5.2 months in MMF 
      and CYC, respectively, p = 0.02). The overall incidence of adverse drug events 
      was lower in the MMF group compared with the CYC group (59.3% vs. 76.4%, 
      p = 0.03). CONCLUSIONS: MMF-RTX is superior to CYC-RTX in maintaining remission 
      with fewer AEs in children with initial SRNS. Additional high-quality randomized 
      control trials with long-term follow-up are needed to identify the long-term 
      potential complications.
CI  - (c) 2022 Pharmacotherapy Publications, Inc.
FAU - Assadi, Farahnak
AU  - Assadi F
AUID- ORCID: 0000-0001-5202-036X
AD  - Division of Nephrology, Department of Pediatrics, Rush University Medical Center, 
      Chicago, Illinois, USA.
FAU - Mazaheri, Mojgan
AU  - Mazaheri M
AD  - Section of Nephrology, Department of Pediatrics, Semnan University of Medical 
      Science, Semnan, Iran.
FAU - Sadeghi-Bodj, Simin
AU  - Sadeghi-Bodj S
AD  - Division of Nephrology, Department of Pediatrics, Zahedan University of Medical 
      Sciences, Zahedan, Iran.
LA  - eng
SI  - IRCT/IRCT20150421021894N
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20220806
PL  - United States
TA  - Pharmacotherapy
JT  - Pharmacotherapy
JID - 8111305
RN  - 0 (Enzyme Inhibitors)
RN  - 0 (Immunosuppressive Agents)
RN  - 0 (Steroids)
RN  - 4F4X42SYQ6 (Rituximab)
RN  - 83HN0GTJ6D (Cyclosporine)
RN  - HU9DX48N0T (Mycophenolic Acid)
SB  - IM
MH  - Child
MH  - Child, Preschool
MH  - *Cyclosporine/adverse effects
MH  - Enzyme Inhibitors/therapeutic use
MH  - Humans
MH  - Immunosuppressive Agents/adverse effects
MH  - Mycophenolic Acid/adverse effects
MH  - *Nephrotic Syndrome/chemically induced/drug therapy
MH  - Rituximab/adverse effects
MH  - Steroids/therapeutic use
MH  - Treatment Outcome
OTO - NOTNLM
OT  - children
OT  - cyclosporine
OT  - mycophenolate mofetil
OT  - rituximab
OT  - steroid-resistant nephrotic syndrome
EDAT- 2022/07/24 06:00
MHDA- 2022/09/17 06:00
CRDT- 2022/07/23 02:52
PHST- 2022/06/23 00:00 [revised]
PHST- 2022/05/09 00:00 [received]
PHST- 2022/06/24 00:00 [accepted]
PHST- 2022/07/24 06:00 [pubmed]
PHST- 2022/09/17 06:00 [medline]
PHST- 2022/07/23 02:52 [entrez]
AID - 10.1002/phar.2721 [doi]
PST - ppublish
SO  - Pharmacotherapy. 2022 Sep;42(9):690-696. doi: 10.1002/phar.2721. Epub 2022 Aug 6.