Safety profile of the interleukin-1 inhibitors anakinra and canakinumab in real-life clinical practice: a nationwide multicenter retrospective observational study

被引：70

作者：

Sota, Jurgen ^{[1
,2
]}

Vitale, Antonio ^{[1
,2
]}

Insalaco, Antonella ^{[3
]}

Sfriso, Paolo ^{[4
]}

Lopalco, Giuseppe ^{[5
]}

Emmi, Giacomo ^{[6
]}

Cattalini, Marco ^{[7
,8
]}

Manna, Raffaele ^{[9
]}

Cimaz, Rolando ^{[10
]}

Priori, Roberta ^{[11
]}

Talarico, Rosaria ^{[12
]}

de Marchi, Ginevra ^{[13
]}

Frassi, Micol ^{[14
,15
]}

Gallizzi, Romina ^{[16
]}

Soriano, Alessandra ^{[17
]}

Alessio, Maria ^{[18
]}

Cammelli, Daniele ^{[19
]}

Maggio, Maria Cristina ^{[20
]}

Gentileschi, Stefano ^{[1
,2
]}

Marcolongo, Renzo ^{[21
]}

La Torre, Francesco ^{[22
]}

Fabiani, Claudia ^{[23
,24
]}

Colafrancesco, Serena ^{[6
]}

Ricci, Francesca ^{[7
,8
]}

Galozzi, Paola ^{[4
]}

Viapiana, Ombretta ^{[25
]}

Verrecchia, Elena ^{[9
]}

Pardeo, Manuela ^{[3
]}

Cerrito, Lucia ^{[9
]}

Cavallaro, Elena ^{[13
]}

Olivieri, Alma Nunzia ^{[26
]}

Paolazzi, Giuseppe ^{[27
]}

Vitiello, Gianfranco ^{[19
]}

Maier, Armin ^{[28
]}

Silvestri, Elena ^{[6
]}

Stagnaro, Chiara ^{[12
]}

Valesini, Guido ^{[6
]}

Mosca, Marta ^{[12
]}

de Vita, Salvatore ^{[13
]}

Tincani, Angela ^{[14
,15
]}

Lapadula, Giovanni ^{[5
]}

Frediani, Bruno ^{[1
,2
]}

De Benedetti, Fabrizio ^{[3
]}

Iannone, Florenzo ^{[5
]}

Punzi, Leonardo ^{[4
]}

Salvarani, Carlo ^{[17
]}

Galeazzi, Mauro ^{[1
,2
]}

Angotti, Rossella ^{[29
]}

Messina, Mario ^{[29
]}

Tosi, Gian Marco ^{[24
]}

机构：

[1] Univ Siena, Policlin Le Scotte, Behcets Dis Clin, Res Ctr Syst Autoinflammatory Dis, Viale Bracci 1, I-53100 Siena, Italy

[2] Univ Siena, Policlin Le Scotte, Rheumatol Ophthalmol Collaborat Uveitis Ctr, Dept Med Sci Surg & Neurosci,Rheumatol Unit, Viale Bracci 1, I-53100 Siena, Italy

[3] Bambino Gesu Pediat Hosp, Div Rheumatol, Dept Pediat Med, IRCCS, Rome, Italy

[4] Univ Padua, Dept Med, Rheumatol Unit, Padua, Italy

[5] Univ Bari, Interdisciplinary Dept Med, Rheumatol Unit, Bari, Italy

[6] Univ Florence, Dept Expt & Clin Med, Florence, Italy

[7] Univ Brescia, Pediat Clin, Brescia, Italy

[8] Spedali Civili Brescia, Brescia, Italy

[9] Univ Cattolica Sacro Cuore, Inst Internal Med, Period Fever Res Ctr, Fdn Policlin A Gemelli, Rome, Italy

[10] AOU Meyer, Pediat Rheumatol Unit, Florence, Italy

[11] Sapienza Univ Rome, Dept Internal Med & Med Specialties, Rheumatol Unit, Rome, Italy

[12] Univ Pisa, Dept Clin & Expt Med, Rheumatol Unit, Pisa, Italy

[13] Univ Udine, Dept Med & Biol Sci, Rheumatol Clin, Udine, Italy

[14] Univ Brescia, Spedali Civili, Rheumatol & Clin Immunol, Brescia, Italy

[15] Univ Brescia, Dept Clin & Expt Sci, Brescia, Italy

[16] Univ Messina, Dept Pediat, Azienda G Martino, Messina, Italy

[17] Ist Ricovero & Cura Carattere Sci, Rheumatol Unit, Dept Internal Med, Azienda Osped ASMN, Reggio Emilia, Italy

[18] Univ Federico II, Naples, Italy

[19] Univ Florence, Expt & Clin Med Dept, Florence, Italy

[20] Univ Palermo, Univ Dept ProSAMI, Palermo, Italy

[21] Univ Padua, Dept Med, Clin Immunol, Padua, Italy

[22] Vito Fazzi Hosp, Pediat Rheumatol Sect, Pediat Oncoematol Unit, Lecce, Italy

[23] Humanitas Res Hosp, Dept Ophthalmol, Milan, Italy

[24] Univ Siena, Dept Med Surg & Neurosci, Ophthalmol Unit, Siena, Italy

[25] Univ Verona, Rheumatol Sect, Dept Med, Verona, Italy

[26] Seconda Univ Naples, Dipartimento Donna Bambino & Chirurg Gen & Specia, Naples, Italy

[27] Santa Chiara Hosp, Dept Rheumatol, Trento, Italy

[28] Osped Bolzano, Struttura Semplice Reumatol, Bolzano, Italy

[29] Univ Siena, Div Pediat Surg, Dept Med Surg & Neurol Sci, Siena, Italy

[30] Univ Cattolica Sacro Cuore, Inst Pediat, Period Fever Res Ctr, Fdn Policlin A Gemelli, I-GRID8142 Rome, Italy

来源：

CLINICAL RHEUMATOLOGY | 2018年 / 37卷 / 08期

关键词：

Anakinra; Autoinflammatory disorders; Canakinumab; Interleukin-1; Safety profile; ONSET STILL-DISEASE; RHEUMATOID-ARTHRITIS; RECEPTOR ANTAGONIST; BEHCETS-DISEASE; ANTI-INTERLEUKIN-1; TREATMENT; PERIODIC SYNDROMES; CASE SERIES; EFFICACY; METHOTREXATE; MANAGEMENT;

D O I：

10.1007/s10067-018-4119-x

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

A few studies have reported the safety profile of interleukin (IL)-1 blockers from real life. The aim of this study is to describe anakinra (ANA) and canakinumab (CAN) safety profile in children and adults, based on data from a real-life setting. Demographic, clinical, and therapeutic data from patients treated with ANA and CAN were retrospectively collected and analyzed. Four hundred and seventy five patients were enrolled; ANA and CAN were prescribed in 421 and 105 treatment courses, respectively. During a mean follow-up of 24.39 +/- 27.04 months, 89 adverse events (AE) were recorded; 13 (14.61%) were classified as serious AE (sAE). The overall estimated rate of AE and sAE was 8.4 per 100 patients/year. Safety concerns were more frequent among patients aged 65 years compared with patients < 16 years (p = 0.002). No differences were detected in the frequency of safety concerns between monotherapy and combination therapy with immunosuppressants (p = 0.055), but a significant difference was observed when injection site reactions were excluded from AE (p = 0.01). No differences were identified in relation to gender (p = 0.462), different lines of biologic therapy (p = 0.775), and different dosages (p = 0.70 ANA; p = 0.39 CAN). The overall drug retention rate was significantly different according to the occurrence of safety concerns (p value < 0.0001); distinguishing between ANA and CAN, significance was maintained only for ANA (p < 0.0001 ANA; p > 0.05 CAN). Treatment duration was the only variable associated with onset of AE (OR = 0.399 [C.I. 0.250-0.638], p = 0.0001). ANA and CAN have shown an excellent safety profile; the risk for AE and sAE tends to decrease over time from the start of IL-1 inhibition.

引用

页码：2233 / 2240

页数：8

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