Factores de riesgo recurrencia penfigo

Published in Dermatology

Journal Scan / Research · April 01, 2020

Factors Associated With Short-Term Relapse in Patients With Pemphigus Who Receive Rituximab as First-Line Therapy

JAMA Dermatology

TAKE-HOME MESSAGE

• In this post hoc analysis, 47 patients with pemphigus vulgaris (PV) or pemphigus foliaceous (PF) received rituximab 1000 mg on days 0 and 14 along with short-term oral corticosteroids as first-line treatment. Of these, 9 patients with PV and 2 with PF experienced disease relapse within 12 months of initiating treatment. There was no significant difference in age, gender, mean BMI, type of pemphigus, or median delay from disease onset to initiation of treatment between those patients who remained clear and those who experienced relapse. Patients who relapsed had higher mean baseline Pemphigus Disease Area Index (PDAI) scores than those who did not relapse (54 vs 28; P=.03). Although statistical significance was not reached, mean baseline anti-DSG1 and anti-DSG3 antibody levels were almost twice as high in patients who relapsed versus those who did not. At month 3, 7 relapsed patients (64%) had antibody levels of ≥20 IU/mL anti-DSG1 and/or ≥130 IU/mL anti-DSG3.

• The authors propose considering a maintenance dose of rituximab at month 6 for patients with baseline PDAI score ≥45 or patients with persistently elevated antibody levels at month 3.

– Caitlyn T. Reed, MD

Abstract

IMPORTANCE

Rituximab and short-term corticosteroid therapy are the criterion standard treatments for patients with newly diagnosed moderate to severe pemphigus.

OBJECTIVE

To examine factors associated with short-term relapse in patients with pemphigus treated with rituximab.

DESIGN, SETTING, AND PARTICIPANTS

This post hoc analysis of a randomized clinical trial (Comparison Between Rituximab Treatment and Oral Corticosteroid Treatment in Patients With Pemphigus [RITUX 3]) conducted from January 1, 2010, to December 31, 2015, included patients from 20 dermatology departments of tertiary care centers in France from the RITUX 3 trial and 3 newly diagnosed patients treated according to the trial protocol. Data analysis was performed from February 1 to June 30, 2019.

EXPOSURE

Patients randomly assigned to the rituximab group in the RITUX 3 trial and the 3 additional patients were treated with 1000 mg of intravenous rituximab on days 0 and 14 and 500 mg at months 12 and 18 combined with a short-term prednisone regimen.

MAIN OUTCOMES AND MEASURES

Baseline (pretreatment) clinical and biological characteristics (Pemphigus Disease Area Index [PDAI] score, ranging from 0-250 points, with higher values indicating more severe disease) and changes in anti-desmoglein (DSG) 1 and anti-DSG3 values as measured by enzyme-linked immunosorbent assay during the 3 months after rituximab treatment were compared between patients with disease relapse and those who maintained clinical remission during the first 12 months after treatment. The positive and negative predictive values of these factors were calculated.

RESULTS

Among 47 patients (mean [SD] age, 54.3 [17.0] years; 17 [36%] male and 30 [64%] female) included in the study, the mean (SD) baseline PDAI score for patients with relapsing disease was higher than that of the patients with nonrelapsing disease (54 [33] vs 28 [24]; P = .03). At month 3, 7 of 11 patients with relapsing disease (64%) vs 7 of 36 patients with nonrelapsing disease (19%) had persistent anti-DSG1 antibody values of 20 IU/mL or higher and/or anti-DSG3 antibody values of 130 IU/mL or higher (P = .01). A PDAI score of 45 or higher defining severe pemphigus and/or persistent anti-DSG1 antibody values of 20 IU/mL or higher and/or anti-DSG3 antibody values of 130 IU/mL or higher at month 3 provided a positive predictive value of 50% (95% CI, 27%-73%) and a negative predictive value of 94% (95% CI, 73%-100%) for the occurrence of relapse after rituximab.

CONCLUSIONS AND RELEVANCE

The findings suggest that initial PDAI score and changes in anti-DSG antibody values after the initial cycle of rituximab might help differentiate a subgroup of patients with high risk of relapse who might benefit from maintenance rituximab infusion at month 6 from a subgroup of patients with low risk of relapse who do not need early maintenance therapy.

JAMA Dermatology

Factors Associated With Short-Term Relapse in Patients With Pemphigus Who Receive Rituximab as First-Line Therapy: A Post Hoc Analysis of a Randomized Clinical Trial

JAMA Dermatol 2020 Mar 18;[EPub Ahead of Print], C Mignard, M Maho-Vaillant, ML Golinski, P Balayé, C Prost-Squarcioni, E Houivet, SB Calbo, B Labeille, C Picard-Dahan, MP Konstantinou, G Chaby, MA Richard, JD Bouaziz, S Duvert-Lehembre, E Delaporte, P Bernard, F Caux, M Alexandre, S Ingen-Housz-Oro, P Vabres, G Quereux, A Dupuy, S Debarbieux, M Avenel-Audran, M D'Incan, C Bédane, N Bénéton, D Jullien, N Dupin, L Misery, L Machet, M Beylot-Barry, O Dereure, B Sassolas, J Benichou, P Joly, V Hébert 

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Benjamin Hidalgo-Matlock
Skin Care Physicians of Costa Rica

Clinica Victoria en San Pedro: 4000-1054
Momentum Escazu: 2101-9574

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