PMID- 32479166
OWN - NLM
STAT- MEDLINE
DCOM- 20201221
LR  - 20210711
IS  - 1539-3704 (Electronic)
IS  - 0003-4819 (Linking)
VI  - 173
IP  - 3
DP  - 2020 Aug 4
TI  - Long-Term Rituximab Use to Maintain Remission of Antineutrophil Cytoplasmic 
      Antibody-Associated Vasculitis: A Randomized Trial.
PG  - 179-187
LID - 10.7326/M19-3827 [doi]
AB  - BACKGROUND: Biannual rituximab infusions over 18 months effectively maintain 
      remission after a "standard" remission induction regimen for patients with 
      antineutrophil cytoplasmic antibody-associated vasculitis (AAV). OBJECTIVE: To 
      evaluate the efficacy of prolonged rituximab therapy in preventing AAV relapses 
      in patients with granulomatosis with polyangiitis (GPA) or microscopic 
      polyangiitis (MPA) who have achieved complete remission after completing an 
      18-month maintenance regimen. DESIGN: Randomized controlled trial. 
      (ClinicalTrials.gov: NCT02433522). SETTING: 39 clinical centers in France. 
      PATIENTS: 68 patients with GPA and 29 with MPA who achieved complete remission 
      after the first phase of maintenance therapy. INTERVENTION: Rituximab or placebo 
      infusion every 6 months for 18 months (4 infusions). MEASUREMENTS: The primary 
      end point was relapse-free survival at month 28. Relapse was defined as new or 
      reappearing symptoms or worsening disease, with a Birmingham Vasculitis Activity 
      Score greater than 0. RESULTS: From March 2015 to April 2016, 97 patients (mean 
      age, 63.9 years; 35% women) were randomly assigned, 50 to the rituximab and 47 to 
      the placebo group. Relapse-free survival estimates at month 28 were 96% (95% CI, 
      91% to 100%) and 74% (CI, 63% to 88%) in the rituximab and placebo groups, 
      respectively, an absolute difference of 22% (CI, 9% to 36%) with a hazard ratio 
      of 7.5 (CI, 1.67 to 33.7) (P = 0.008). Major relapse-free survival estimates at 
      month 28 were 100% (CI, 93% to 100%) versus 87% (CI, 78% to 97%) (P = 0.009), 
      respectively. At least 1 serious adverse event developed in 12 patients (24%) in 
      the rituximab group (with 9 infectious serious adverse events occurring among 6 
      patients [12%]) versus 14 patients (30%) in the placebo group (with 6 infectious 
      serious adverse events developing among 4 patients [9%]). No deaths occurred in 
      either group. LIMITATION: Potential selection bias based on previous rituximab 
      response and tolerance. CONCLUSION: Extended therapy with biannual rituximab 
      infusions over 18 months was associated with a lower incidence of AAV relapse 
      compared with standard maintenance therapy. PRIMARY FUNDING SOURCE: French 
      Ministry of Health and Hoffmann-La Roche.
FAU - Charles, Pierre
AU  - Charles P
AD  - Cochin Hospital, Paris Descartes University, and Institut Mutualiste Montsouris, 
      Paris, France (P.C.).
FAU - Perrodeau, Elodie
AU  - Perrodeau E
AD  - Centre d'Epidemiologie Clinique, Hopital Hotel-Dieu, Universite Paris Descartes, 
      Sorbonne Paris Cite INSERM Unite 1153, Paris, France (E.P., P.R.).
FAU - Samson, Maxime
AU  - Samson M
AD  - Centre Hospitalier Universitaire de Dijon, INSERM, UMR 1098, University of 
      Bourgogne Franche-Comte, FHU INCREASE, Dijon, France (M.S., B.B.).
FAU - Bonnotte, Bernard
AU  - Bonnotte B
AD  - Centre Hospitalier Universitaire de Dijon, INSERM, UMR 1098, University of 
      Bourgogne Franche-Comte, FHU INCREASE, Dijon, France (M.S., B.B.).
FAU - Neel, Antoine
AU  - Neel A
AD  - CRTI UMR 1064, INSERM, Universite de Nantes, and Centre Hospitalier Universitaire 
      Nantes, Nantes, France (A.N.).
FAU - Agard, Christian
AU  - Agard C
AD  - Centre Hospitalier Universitaire Nantes, Nantes, France (C.A.).
FAU - Huart, Antoine
AU  - Huart A
AD  - Centre Hospitalier Universitaire de Toulouse, Toulouse, France (A.H., G.P.).
FAU - Karras, Alexandre
AU  - Karras A
AD  - Hopital Europeen Georges-Pompidou, Universite Paris Descartes, Paris, France 
      (A.K.).
FAU - Lifermann, Francois
AU  - Lifermann F
AD  - Centre Hospitalier de Dax, Dax, France (F.L.).
FAU - Godmer, Pascal
AU  - Godmer P
AD  - Centre Hospitalier Bretagne Atlantique de Vannes, Vannes, France (P.G.).
FAU - Cohen, Pascal
AU  - Cohen P
AD  - Cochin Hospital, Paris Descartes University, Paris, France (P.C., C.V., X.P., 
      B.T., L.M., L.G.).
FAU - Hanrotel-Saliou, Catherine
AU  - Hanrotel-Saliou C
AD  - Hopital la Cavale Blanche, Centre Hospitalier Universitaire Brest, Brest, France 
      (C.H.).
FAU - Martin-Silva, Nicolas
AU  - Martin-Silva N
AD  - Centre Hospitalier Universitaire de Caen, Caen, France (N.M.).
FAU - Pugnet, Gregory
AU  - Pugnet G
AD  - Centre Hospitalier Universitaire de Toulouse, Toulouse, France (A.H., G.P.).
FAU - Maurier, Francois
AU  - Maurier F
AD  - Hopitaux Prives de Metz, Metz, France (F.M.).
FAU - Sibilia, Jean
AU  - Sibilia J
AD  - Hopital de Hautepierre, Centre Hospitalier Universitaire de Strasbourg, 
      Strasbourg, France (J.S.).
FAU - Carron, Pierre-Louis
AU  - Carron PL
AD  - Centre Hospitalier Universitaire Grenoble Alpes, Grenoble, France (P.C.).
FAU - Gobert, Pierre
AU  - Gobert P
AD  - Clinique Rhone Durance, Avignon, France (P.G.).
FAU - Meaux-Ruault, Nadine
AU  - Meaux-Ruault N
AD  - Centre Hospitalier Universitaire Jean-Minjoz, Besancon, France (N.M.).
FAU - Le Gallou, Thomas
AU  - Le Gallou T
AD  - Centre Hospitalier Universitaire de Rennes, Rennes, France (T.L.).
FAU - Vinzio, Stephane
AU  - Vinzio S
AD  - Groupe Hospitalier Mutualiste de Grenoble, Grenoble, France (S.V.).
FAU - Viallard, Jean-Francois
AU  - Viallard JF
AD  - Centre Hospitalier Universitaire de Bordeaux, Pessac, France (J.V.).
FAU - Hachulla, Eric
AU  - Hachulla E
AD  - Centre Hospitalier Universitaire de Lille, Lille, France (E.H.).
FAU - Vinter, Christine
AU  - Vinter C
AD  - Cochin Hospital, Paris Descartes University, Paris, France (P.C., C.V., X.P., 
      B.T., L.M., L.G.).
FAU - Puechal, Xavier
AU  - Puechal X
AD  - Cochin Hospital, Paris Descartes University, Paris, France (P.C., C.V., X.P., 
      B.T., L.M., L.G.).
FAU - Terrier, Benjamin
AU  - Terrier B
AD  - Cochin Hospital, Paris Descartes University, Paris, France (P.C., C.V., X.P., 
      B.T., L.M., L.G.).
FAU - Ravaud, Philippe
AU  - Ravaud P
AD  - Centre d'Epidemiologie Clinique, Hopital Hotel-Dieu, Universite Paris Descartes, 
      Sorbonne Paris Cite INSERM Unite 1153, Paris, France (E.P., P.R.).
FAU - Mouthon, Luc
AU  - Mouthon L
AD  - Cochin Hospital, Paris Descartes University, Paris, France (P.C., C.V., X.P., 
      B.T., L.M., L.G.).
FAU - Guillevin, Loic
AU  - Guillevin L
AD  - Cochin Hospital, Paris Descartes University, Paris, France (P.C., C.V., X.P., 
      B.T., L.M., L.G.).
CN  - French Vasculitis Study Group
LA  - eng
SI  - ClinicalTrials.gov/NCT02433522
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20200602
PL  - United States
TA  - Ann Intern Med
JT  - Annals of internal medicine
JID - 0372351
RN  - 0 (Immunologic Factors)
RN  - 4F4X42SYQ6 (Rituximab)
SB  - IM
CIN - Ann Intern Med. 2020 Aug 4;173(3):235-236. PMID: 32479173
CIN - Ann Intern Med. 2020 Dec 1;173(11):948. PMID: 33253611
CIN - Ann Intern Med. 2020 Dec 1;173(11):947-948. PMID: 33253612
CIN - Ann Intern Med. 2020 Dec 1;173(11):947. PMID: 33253614
MH  - Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis/*drug therapy
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Immunologic Factors/administration & dosage/*therapeutic use
MH  - Infusions, Intravenous
MH  - Male
MH  - Middle Aged
MH  - Rituximab/administration & dosage/*therapeutic use
MH  - Treatment Outcome
FIR - Matignon, Marie
IR  - Matignon M
FIR - Aumaitre, Olivier
IR  - Aumaitre O
FIR - Regent, Alexis
IR  - Regent A
FIR - Bienvenu, Boris
IR  - Bienvenu B
FIR - Gil, Helder
IR  - Gil H
FIR - Fabre, Marc
IR  - Fabre M
FIR - Galempoix, Jean-Marc
IR  - Galempoix JM
FIR - Bonnin, Anthony
IR  - Bonnin A
FIR - Noel, Nicolas
IR  - Noel N
FIR - Chatelus, Emmanuel
IR  - Chatelus E
FIR - Larroche, Claire
IR  - Larroche C
FIR - Schleinitz, Nicolas
IR  - Schleinitz N
FIR - Marie, Isabelle
IR  - Marie I
FIR - Lavigne, Christian
IR  - Lavigne C
FIR - Mestrallet, Stephanie
IR  - Mestrallet S
FIR - Lazaro, Estibaliz
IR  - Lazaro E
FIR - Perard, Laurent
IR  - Perard L
FIR - Damade, Richard
IR  - Damade R
FIR - Delbes, Sebastien
IR  - Delbes S
FIR - Kassem, Hassan
IR  - Kassem H
FIR - Jarrin, Irene
IR  - Jarrin I
FIR - de Menthon, Mathilde
IR  - de Menthon M
FIR - Closs-Prophette, Fabienne
IR  - Closs-Prophette F
FIR - Fur, Alain
IR  - Fur A
FIR - de Bouverie, Odile
IR  - de Bouverie O
FIR - Daugas, Eric
IR  - Daugas E
FIR - Jourde-Chiche, Noemie
IR  - Jourde-Chiche N
EDAT- 2020/06/02 06:00
MHDA- 2020/12/22 06:00
CRDT- 2020/06/02 06:00
PHST- 2020/06/02 06:00 [pubmed]
PHST- 2020/12/22 06:00 [medline]
PHST- 2020/06/02 06:00 [entrez]
AID - 10.7326/M19-3827 [doi]
PST - ppublish
SO  - Ann Intern Med. 2020 Aug 4;173(3):179-187. doi: 10.7326/M19-3827. Epub 2020 Jun 
      2.