Blog entry by Meguid El Nahas

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by Meguid El Nahas - Wednesday, 28 May 2014, 1:13 PM
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PROFESSOR PIERRE DELANAYE COMMENTED ON THIS ARTICLE:

J Am Soc Nephrol. 2014 Apr;25(4):850-63. doi: 10.1681/ASN.2013030251. Epub 2014 Jan 30.

Rituximab in steroid-dependent or frequently relapsing idiopathic nephrotic syndrome.

 

Abstract

The outcome of steroid-dependent or frequently relapsing nephrotic syndrome of minimal change disease (MCD), mesangial proliferative GN (MesGN), or FSGS may be poor and with major treatment toxicity. This academic, multicenter, off-on trial (ClinicalTrials.gov #NCT00981838) primarily evaluated the effects of rituximab therapy followed by immunosuppression withdrawal on disease recurrence in 10 children and 20 adults with MCD/MesGN (n=22) or FSGS who had suffered ≥2 recurrences over the previous year and were in steroid-induced remission for ≥1 month. Participants received one dose (n=28) or two doses of rituximab (375 mg/m(2) intravenously). At 1 year, all patients were in remission: 18 were treatment-free and 15 never relapsed. Compared with the year before rituximab treatment, total relapses decreased from 88 to 22 and the per-patient median number of relapses decreased from 2.5 (interquartile range [IQR], 2-4) to 0.5 (IQR, 0-1; P<0.001) during 1 year of follow-up. Reduction was significant across subgroups (children, adults, MCD/MesGN, and FSGS; P<0.01). After rituximab, the per-patient steroid maintenance median dose decreased from 0.27 mg/kg (IQR, 0.19-0.60) to 0 mg/kg (IQR, 0-0.23) (P<0.001), and the median cumulative dose to achieve relapse remission decreased from 19.5 mg/kg (IQR, 13.0-29.2) to 0.5 mg/kg (IQR, 0-9.4) (P<0.001). Furthermore, the mean estimated GFR increased from 111.3±25.7 to 121.8±29.2 ml/min per 1.73 m(2) (P=0.01), with the largest increases in children and in FSGS subgroups. The mean height z score slope stabilized in children (P<0.01). Treatment was well tolerated. Rituximab effectively and safely prevented recurrences and reduced the need for immunosuppression in steroid-dependent or frequently relapsing nephrotic syndrome, and halted disease-associated growth deficit in children.

COMMENTS:

Une étude publiée en avril 2014 dans le JASN par les collègues italiens de Bergame.

Ils ont étudié l'effet du rituximab chez 30 patients avec GN (minimal change, mesangio-proliférative ou FSGS) et une cortico dépendance ou des récidives fréquentes. Le rituximab est administré à une dose unique de 375 mg/m² (une deuxième dose chez deux patients qui n'ont pas répondu en terme de lymphocytes . Les résultats sont intéressants à 1 et à 2 ans. Le nombre de récidive est diminué de 5X. 18 patients sur 30 ne sont plus traités, y compris sans corticoides. L'effet "steroid-sparing" me parait prouvé par différente analyse. Bien sûr, il s'agit d'une étude non randomisée (le nombre de récidive à 1 an est comparé au nombre de récidive l'année précédent le ritux) mais il faut aussi avouer qu'une étude randomisée est probablement impossible vu la rareté de la maladie.

Attention cette étude concernait des patients en rémission au moment de l'administration du rituximab! Il ne s'agissait donc pas de patient coritico RESISTANT.

Très belle étude dans son genre il me semble... 

Translated as:

Important and significant stuy in SDNS where patient salready in remission under corticotherapy were treated with a single dose (375mg/m2) of Rituximab and obtained a sustained remission compared to their frequent relapses before hand. 

Of note, it is NOT a study of steroid resistant nephrotic syndrome as all th epatients were in remission by steroids at the time of Rituximab administration. So instead it is a study of Steroid Dependant (frequent relapsing) nephrotic syndrome (SDNS).

Also, this is NOT a randomised controlled study.But to conduct such a study would be difficult.

Elegant study of its kind, it seems.

 

 
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