Rituximab versus Conventional Therapeutic Strategy for Remission Induction in Eosinophilic Granulomatosis with Polyangiitis: A Double-blind, Randomized, Controlled Trial

Benjamin Terrier¹, Gregory Pugnet², Claire de Moreuil³, Bernard Bonnotte⁴, Ygal Benhamou⁵, Elisabeth Diot⁶, Dominique Chauveau², Pierre Duffau⁷, Nicolas Limal⁸, Antoine Neel⁹, Geoffrey Urbanski¹⁰, Noemie Jourde-Chiche¹¹, Nicolas Martin-Silva¹², Francois Maurier¹³, Arsene Mekinian¹⁴, Nicolas Schleinitz¹¹, Felix Ackermann¹⁵, Anne-Laure Fauchais¹⁶, Antoine Froissart¹⁷, Thomas Le Gallou¹⁸, Yurdagul Uzunhan¹⁹, Jean-Francois Viallard⁷, Alice Berezne²⁰, Laurent Chiche²¹, Bruno Crestani¹⁴, Guillaume Direz²², Cecile-Audrey Durel²³, Pascal Godmer²⁴, Jean-Emmanuel Kahn²⁵, Marc Lambert²⁶, Thomas Quemeneur²⁷, Jacques Cadranel¹⁴, Pierre Charles²⁸, Antoine Dossier¹⁴, Lea Jilet²⁹, Loic Guillevin¹⁴, Hendy Abdoul²⁹ and Xavier Puechal¹⁴, ¹Cochin Hospital, Paris, France, ²CHU, Toulouse, France, ³CHU, Brest, France, ⁴CHU, Dijon, France, ⁵CHU, Rouen, France, ⁶CHU, Tours, France, ⁷CHU, Bordeaux, France, ⁸CHU, Creteil, France, ⁹CHU, Nantes, France, ¹⁰CHU, Angers, France, ¹¹CHU, Marseille, France, ¹²CHU, Caen, France, ¹³CH, Metz, France, ¹⁴CHU, Paris, France, ¹⁵Hopital Foch, Suresnes, France, ¹⁶CHU, Limoges, France, ¹⁷CHIC, Creteil, France, ¹⁸CHU, Rennes, France, ¹⁹CHU, Bobigny, France, ²⁰CH, Annecy, France, ²¹CH, Marseille, France, ²²CH, Le Mans, France, ²³CHU, Lyon, France, ²⁴CH, Vannes, France, ²⁵CHU, Boulogne, France, ²⁶CHRU, Lille, France, ²⁷CH, Valenciennes, France, ²⁸CH, Paris, France, ²⁹URC, Paris, France

Meeting: ACR Convergence 2021

Date of first publication: October 22, 2021

Keywords: B-Cell Targets, Eosinophilic Granulomatosus with Polyangiitis (Churg-Strauss), Late-Breaking 2021, Randomized Trial, Vasculitis

Session Information

Date: Tuesday, November 9, 2021

Title: Late-Breaking Abstracts (L16 - L21)

Session Type: Late-Breaking Abstract Session

Session Time: 11:45AM-12:00PM

Background/Purpose: Eosinophilic granulomatosis with polyangiitis (EGPA) is an eosinophilic ANCA-associated vasculitis.Glucocorticoids, alone or in combination with cyclophosphamide in severe forms, induce remission in most patients with EGPA. Rituximab, an anti-CD20 monoclonal antibody depleting B cells, demonstrated efficacy in other ANCA-associated vasculitides. Rituximab might be indicated in the treatment of EGPA.

Methods: This phase 3, comparative, multicenter, randomized, controlled, double-blind and superiority research compared rituximab-based regimen with conventional therapeutic strategies for the induction of remission.Patients with newly diagnosed or relapsing disease were randomized in a 1:1 ratio to receive: the experimental therapeutic strategy based on the use of rituximab, or the conventional therapeutic strategy based on Five-Factor Score (FFS)-assessed disease severity. The primary end point was the rate of patients who achieved remission at day 180 as defined by BVAS=0 and a prednisone dose ≤7.5 mg/day. Secondary end points were duration of remission during the study period, the average daily glucocorticoid dose and safety.

Results: A total of 105 participants underwent randomization (74 with newly diagnosed EGPA, 63 with FFS=0, 59 with negative ANCA), with 52 participants assigned to receive rituximab and 53 to conventional strategy. At day 180, remission was achieved in 33 patients in the rituximab group (63.5%) and in 32 patients in the conventional strategy group (60.4%) (relative risk, 1.05; 95% confidence interval, 0.78 to 1.42, P=0.75). At day 360, remission was achieved in 31 patients in the rituximab group (59.6%) and in 34 patients in the conventional strategy group (64.2%) (relative risk, 1.08; 95% CI, 0.80 to 1.45, P=0.63).

Mean duration of remission was 16.4 (10.37) and 16.2 (11.68) weeks in the rituximab group and the conventional strategy group, respectively. All relapse and major relapse rates were comparable between the two groups. SF-36 was similar between the two groups. However, health assessment questionnaire (HAQ) at day 180 and day 360 (p=0.07 and p=0.09, respectively) and vasculitis damage index (VDI) at day 360 (p=0.07) tended to be better in the rituximab group. There was no significant difference in average daily glucocorticoid dose between the two arms, with an area under the curve of 4591 mg in the rituximab group and 4453 mg for the conventional strategy group.

Conclusion: In EGPA patients participating to this double-blind randomized controlled trial, rituximab was not superior to conventional therapeutic strategy based on FFS to induce vasculitis remission (Funded by the French Ministry of Health; REOVAS ClinicalTrials.gov number, NCT02807103).

B. Terrier, None; G. Pugnet, None; C. de Moreuil, None; B. Bonnotte, None; Y. Benhamou, None; E. Diot, None; D. Chauveau, None; P. Duffau, None; N. Limal, None; A. Neel, None; G. Urbanski, None; N. Jourde-Chiche, None; N. Martin-Silva, None; F. Maurier, None; A. Mekinian, None; N. Schleinitz, None; F. Ackermann, None; A. Fauchais, None; A. Froissart, None; T. Le Gallou, None; Y. Uzunhan, None; J. Viallard, None; A. Berezne, None; L. Chiche, None; B. Crestani, None; G. Direz, None; C. Durel, None; P. Godmer, None; J. Kahn, None; M. Lambert, None; T. Quemeneur, None; J. Cadranel, None; P. Charles, None; A. Dossier, None; L. Jilet, None; L. Guillevin, None; H. Abdoul, None; X. Puechal, None.

To cite this abstract in AMA style:

Terrier B, Pugnet G, de Moreuil C, Bonnotte B, Benhamou Y, Diot E, Chauveau D, Duffau P, Limal N, Neel A, Urbanski G, Jourde-Chiche N, Martin-Silva N, Maurier F, Mekinian A, Schleinitz N, Ackermann F, Fauchais A, Froissart A, Le Gallou T, Uzunhan Y, Viallard J, Berezne A, Chiche L, Crestani B, Direz G, Durel C, Godmer P, Kahn J, Lambert M, Quemeneur T, Cadranel J, Charles P, Dossier A, Jilet L, Guillevin L, Abdoul H, Puechal X. Rituximab versus Conventional Therapeutic Strategy for Remission Induction in Eosinophilic Granulomatosis with Polyangiitis: A Double-blind, Randomized, Controlled Trial [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/rituximab-versus-conventional-therapeutic-strategy-for-remission-induction-in-eosinophilic-granulomatosis-with-polyangiitis-a-double-blind-randomized-controlled-trial/. Accessed .

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