Mepolizumab for Eosinophilic Granulomatosis With Polyangiitis: A European Multicenter Observational Study

被引:102
作者
Bettiol, Alessandra [1 ]
Urban, Maria Letizia [1 ]
Dagna, Lorenzo [2 ]
Cottin, Vincent [3 ]
Franceschini, Franco [4 ,5 ]
Del Giacco, Stefano [6 ]
Schiavon, Franco [7 ]
Neumann, Thomas [8 ,9 ]
Lopalco, Giuseppe [10 ]
Novikov, Pavel [11 ]
Baldini, Chiara [12 ]
Lombardi, Carlo [13 ]
Berti, Alvise [14 ,15 ]
Alberici, Federico [16 ,17 ]
Folci, Marco [18 ,19 ]
Negrini, Simone [20 ,21 ]
Sinico, Renato Alberto [22 ]
Quartuccio, Luca [23 ]
Lunardi, Claudio [24 ]
Parronchi, Paola [1 ]
Moosig, Frank [25 ]
Espigol-Frigole, Georgina [26 ,27 ]
Schroeder, Jan [28 ]
Kernder, Anna Luise [29 ]
Monti, Sara [30 ]
Silvagni, Ettore [31 ]
Crimi, Claudia [32 ]
Cinetto, Francesco [33 ]
Fraticelli, Paolo [34 ]
Roccatello, Dario [35 ,36 ]
Vacca, Angelo [37 ]
Mohammad, Aladdin J. [38 ,39 ]
Hellmich, Bernhard [40 ]
Samson, Maxime [41 ]
Bargagli, Elena [42 ]
Cohen Tervaert, Jan Willem [43 ,44 ]
Ribi, Camillo [45 ]
Fiori, Davide [1 ]
Bello, Federica [1 ]
Fagni, Filippo [1 ]
Moroni, Luca [2 ]
Ramirez, Giuseppe Alvise [2 ]
Nasser, Mouhamad [3 ]
Marvisi, Chiara [46 ,47 ]
Toniati, Paola [48 ]
Firinu, Davide [6 ]
Padoan, Roberto [7 ]
Egan, Allyson [49 ]
Seeliger, Benjamin [50 ]
Iannone, Florenzo [10 ]
机构
[1] Univ Florence, Florence, Italy
[2] Salute San Raffaele Univ, San Raffaele Hosp, IRCCS, Milan, Italy
[3] Hosp Civils Lyon & Univ Lyon, Lyon, France
[4] ASST Spedali Civili Brescia, Brescia, Italy
[5] Univ Brescia, Brescia, Italy
[6] Univ Cagliari, Cagliari, Italy
[7] Univ Padua, Azienda Ospedaliera, Padua, Italy
[8] Cantonal Hosp St Gallen, St Gallen, Switzerland
[9] Jena Univ Hosp, Jena, Germany
[10] Univ Bari, Polyclin Hosp, Bari, Italy
[11] Sechenov First Moscow State Med Univ, Tareev Clin Internal Dis, Moscow, Russia
[12] Univ Pisa, Pisa, Italy
[13] Fdn Poliambulanza Ist Ospedaliero, Brescia, Italy
[14] Santa Chiara Hosp, Trento, Italy
[15] Univ Trento, Trento, Italy
[16] Univ Brescia, Brescia, Italy
[17] Spedali Civili Hosp, ASST Spedali Civili Brescia, Brescia, Italy
[18] IRCCS, Humanitas Clin & Res Ctr, Milan, Italy
[19] Humanitas Univ, IRCCS, Milan, Italy
[20] IRCCS Osped Policlin San Martino, Genoa, Italy
[21] Univ Genoa, Genoa, Italy
[22] Univ Milano Bicocca, Monza, Italy
[23] Univ Udine, Azienda sanitaria Univ Friuli Cent Udine, Udine, Italy
[24] Univ Verona, Verona, Italy
[25] Rheumazentrum Schleswig Holstein Mitte, Neumunster, Germany
[26] Univ Barcelona, Hosp Clin, Barcelona, Spain
[27] Inst Invest Biomed August Pi & Sunyer IDIBAPS, Barcelona, Spain
[28] ASST Grande Osped Metropolitano Niguarda, Milan, Italy
[29] Heinrich Heine Univ Dusseldorf, Dusseldorf, Germany
[30] Univ Pavia, Policlinico S Matteo Fdn, IRCCS, Pavia, Italy
[31] Univ Ferrara, Ferrara, Italy
[32] Policlin Vittorio Emanuele San Marco Univ Hosp, Catania, Italy
[33] Univ Padua, Padua, Italy
[34] Univ Hosp Ospedali Riuniti, Ancona, Italy
[35] San Giovanni Bosco Hosp, Turin, Italy
[36] Univ Turin, Turin, Italy
[37] Aldo Moro Univ Bari, Bari, Italy
[38] Lund Univ, Skane Univ Hosp, Cambridge, England
[39] Univ Cambridge, Cambridge, England
[40] Univ Tubingen, Medius Kliniken, Kirchheim Unter Teck, Germany
[41] Dijon Univ Hosp, Dijon, France
[42] Univ Siena, Siena, Italy
[43] Univ Alberta, Maastricht, Netherlands
[44] Maastricht Univ, Maastricht, Netherlands
[45] Univ Hosp Ctr Lausanne, Lausanne, Switzerland
[46] IRCCS, Azienda USL IRCCS Reggio Emilia, Reggio Emilia, Italy
[47] Univ Modena & Reggio Emilia, Reggio Emilia, Italy
[48] ASST Spedali Civili Brescia, Brescia, Italy
[49] Univ Cambridge, Cambridge, England
[50] Hannover Med Sch, Hannover, Germany
关键词
FOLLOW-UP; PLACEBO; EGPA; SAFETY;
D O I
10.1002/art.41943
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objective Mepolizumab proved to be an efficacious treatment for eosinophilic granulomatosis with polyangiitis (EGPA) at a dose of 300 mg every 4 weeks in the randomized, controlled MIRRA trial. In a few recently reported studies, successful real-life experiences with the approved dose for treating severe eosinophilic asthma (100 mg every 4 weeks) were observed. We undertook this study to assess the effectiveness and safety of mepolizumab 100 mg every 4 weeks and 300 mg every 4 weeks in a large European EGPA cohort. Methods We included all patients with EGPA treated with mepolizumab at the recruiting centers in 2015-2020. Treatment response was evaluated from 3 months to 24 months after initiation of mepolizumab. Complete response to treatment was defined as no disease activity (Birmingham Vasculitis Activity Score [BVAS] = 0) and a prednisolone or prednisone dose (or equivalent) of <= 4 mg/day. Respiratory outcomes included asthma and ear, nose, and throat (ENT) exacerbations. Results Two hundred three patients, of whom 191 received a stable dose of mepolizumab (158 received 100 mg every 4 weeks and 33 received 300 mg every 4 weeks) were included. Twenty-five patients (12.3%) had a complete response to treatment at 3 months. Complete response rates increased to 30.4% and 35.7% at 12 months and 24 months, respectively, and rates were comparable between mepolizumab 100 mg every 4 weeks and 300 mg every 4 weeks. Mepolizumab led to a significant reduction in BVAS score, prednisone dose, and eosinophil counts from 3 months to 24 months, with no significant differences observed between 100 mg every 4 weeks and 300 mg every 4 weeks. Eighty-two patients (40.4%) experienced asthma exacerbations (57 of 158 [36%] who received 100 mg every 4 weeks; 17 of 33 [52%] who received 300 mg every 4 weeks), and 31 patients (15.3%) experienced ENT exacerbations. Forty-four patients (21.7%) experienced adverse events (AEs), most of which were nonserious AEs (38 of 44). Conclusion Mepolizumab at both 100 mg every 4 weeks and 300 mg every 4 weeks is effective for the treatment of EGPA. The 2 doses should be compared in the setting of a controlled trial.
引用
收藏
页码:295 / 306
页数:12
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