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First-line rituximab combined with short-term prednisone versus prednisone alone for the treatment of pemphigus (Ritux 3): a prospective, multicentre, parallel-group, open-label randomised trial
- Source :
- Lancet, Lancet, Elsevier, 2017, 389 (10083), pp.2031-2040. ⟨10.1016/S0140-6736(17)30070-3⟩, Lancet, Elsevier, 2017, 389 (10083), pp.2031-2040. 〈http://www.sciencedirect.com/science/article/pii/S0140673617300703〉. 〈10.1016/S0140-6736(17)30070-3〉, The Lancet, The Lancet, 2017, 389 (10083), pp.2031-2040. ⟨10.1016/S0140-6736(17)30070-3⟩
- Publication Year :
- 2017
- Publisher :
- HAL CCSD, 2017.
-
Abstract
- IF 44.002; International audience; Background High doses of corticosteroids are considered the standard treatment for pemphigus. Because long-term corticosteroid treatment can cause severe and even life-threatening side-effects in patients with this disease, we assessed whether first-line use of rituximab as adjuvant therapy could improve the proportion of patients achieving complete remission off-therapy, compared with corticosteroid treatment alone, while decreasing treatment side-effects of corticosteroids.Methods We did a prospective, multicentre, parallel-group, open-label, randomised trial in 25 dermatology hospital departments in France (Ritux 3). Eligible participants were patients with newly diagnosed pemphigus aged 18-80 years being treated for the first time (not at the time of a relapse). We randomly assigned participants (1: 1) to receive either oral prednisone alone, 1.0 or 1.5 mg/kg per day tapered over 12 or 18 months (prednisone alone group), or 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, 0.5 or 1.0 mg/kg per day tapered over 3 or 6 months (rituximab plus short-term prednisone group). Follow-up was for 3 years (study visits were scheduled weekly during the first month of the study, then monthly until month 24, then an additional visit at month 36). Treatment was assigned through central computer-generated randomisation, with stratification according to disease-severity (severe or moderate, based on Harman's criteria). The primary endpoint was the proportion of patients who achieved complete remission off-therapy at month 24 (intention-to-treat analysis). This study is registered with ClinicalTrials.gov, number NCT00784589.Findings Between May 10, 2010, and Dec 7, 2012, we enrolled 91 patients and randomly assigned 90 to treatment (90 were analysed; 1 patient withdrew consent before the random assignment). At month 24, 41 (89%) of 46 patients assigned to rituximab plus short-term prednisone were in complete remission off-therapy versus 15 (34%) of 44 assigned to prednisone alone (absolute difference 55 percentage points, 95% CI 38.4-71.7; p
- Subjects :
- 0301 basic medicine
Adult
Male
medicine.medical_specialty
Prednisolone
Follow-Up
Vulgaris
law.invention
030207 dermatology & venereal diseases
03 medical and health sciences
0302 clinical medicine
Randomized controlled trial
Prednisone
law
Internal medicine
[ SDV.MHEP ] Life Sciences [q-bio]/Human health and pathology
Antineoplastic Combined Chemotherapy Protocols
medicine
Clinical endpoint
Humans
Corticosteroids
Disease
Prospective Studies
Prospective cohort study
Adjuvant
Aged
business.industry
Standard treatment
General Medicine
Middle Aged
Mycophenolate-Mofetil
medicine.disease
3. Good health
Surgery
Pemphigus
Regimen
030104 developmental biology
Treatment Outcome
Combination
Rituximab
Female
Therapy
business
Single-Cycle
Intensity Score Absis
[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
medicine.drug
Subjects
Details
- Language :
- English
- ISSN :
- 01406736 and 1474547X
- Database :
- OpenAIRE
- Journal :
- Lancet, Lancet, Elsevier, 2017, 389 (10083), pp.2031-2040. ⟨10.1016/S0140-6736(17)30070-3⟩, Lancet, Elsevier, 2017, 389 (10083), pp.2031-2040. 〈http://www.sciencedirect.com/science/article/pii/S0140673617300703〉. 〈10.1016/S0140-6736(17)30070-3〉, The Lancet, The Lancet, 2017, 389 (10083), pp.2031-2040. ⟨10.1016/S0140-6736(17)30070-3⟩
- Accession number :
- edsair.doi.dedup.....80eaa72d54c2a1695ae407ee3b52f5bc
- Full Text :
- https://doi.org/10.1016/S0140-6736(17)30070-3⟩