ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 265

Tocilizumab Compared with Anakinra in Refractory Adult-Onset Still’s Disease. Multicenter Study of 75 Patients

Leyre Riancho-Zarrabeitia1, Vanesa Calvo-Río1, Ricardo Blanco1, Jose L. Hernández2, Francisco Ortiz-Sanjuán1, Alejandro Olivé3, Anne Riveros Frutos4, Santos Castañeda5, Javier Narváez6, Maria Luisa Velloso Feijoo7, M. Victoria Hernández8, Alberto Sifuentes Giraldo9, Olga Maiz-Alonso10, Esteban Rubio Romero11, Cristina Mata-Arnaiz12, Adela Gallego Flores13, Jordi del Blanco14, Catalina Gómez-Arango15, Sara Manrique-Arija16, Maria Carmen Ordoñez17, Inmaculada Ros Vilamajo18, Miguel Angel Caracuel-Ruiz19, Mercedes Freire20, Jose Llobet21, Carlos Marras22, Concepción Moll Tuduri23, Chamaida Plasencia24, Rosa Roselló25, Ana Urruticoechea26, Inmaculada Jiménez-Moleón27, José Antonio Bernal28, Vera Ortiz-Santamaría29, Juan Ramón De Dios30, Mireia Moreno31, Jordi Fiter32, Marina de los Riscos33, Patricia E. Carreira33, María José Rodríguez Valls Sr.34, Carmen Gonzalez-Vela35, Javier Loricera1, Natalia Palmou1 and Miguel Angel Gonzalez-Gay1, 1Rheumatology, Hospital Universitario Marqués de Valdecilla. IDIVAL, Santander, Spain, 2Internal Medicine, Hospital Universitario Marqués de Valdecilla. IDIVAL, Santander, Spain, 3Rheumatology, Hospital U German Trias i Pujol, Badalona, Spain, 4Rheumatology, Hospital Universitari Germans Trias i Pujol, Barcelona, Spain, 5Rheumatology, H.U. La Princesa, Madrid, Spain, 6Rheumatology, Hospital Universitario de Bellvitge, Barcelona, Spain, 7H Valme, Sevilla, Spain, 8Arthritis Unit, Rheumatology, Hospital Clinic, Barcelona, Spain, 9Department of Rheumatology, University Hospital Ramón y Cajal, Madrid, Spain, 10Rheumatology, HU Donostia, San Sebastián, Spain, 11Rheumatology Department,, Hospital Universitario Virgen del Rocío, Sevilla, Spain, 12Rheumatology, Hospital Laredo, Santander, Spain, 13Rheumatology, Hospital de Mérida, Mérida, Spain, 14Rheumatology, H Sant Jaume, Calella, Spain, 15Rheumatology, Hospital Basurto,, Santander, Spain, 16Rheumatology, Hospital Universitario Carlos Haya, Malaga, Spain, 17HRU Carlos Haya, Malaga, Spain, 18Hospital Son Llàtzer, Palma de Mallorca, Spain, 19Plaza Cruz Roja, 1, Hospital Reina Sofia, Córdoba, Spain, 20Hospital Universitario Juan Canalejo, La Coruña, Spain, 21Hospital San Pau, Barcelona, Spain, 22Hospital Universitario Virgen de la Arrixaca, Murcia, Spain, 23H Mateu Orfila, Mahón, Spain, 24Rheumatology Unit, La Paz University Hospital-Rheumatology, Madrid, Spain, 25H San Jorge, Huesca, Spain, 26Hospital Can Misses, Ibiza, Spain, 27Rheumatology, Hospital San Cecilio, Granada, Spain, 28Sección de Reumatología, Hospital General Universitario de Alicante, Alicante, Spain, 29Rheumatology, Hospital General. Granollers., Granollers, Spain, 30Rheumatology, HU Álava, Vitoria, Spain, 31Hospital de Sabadell - Institut Universitari Parc Taulí, Sabadell, Spain, 32Rheumatology, HU Son Espases. Palma de Mallorca., Palma de Mallorca, Spain, 33Rheumatology, Hospital Universitario 12 de Octubre, Madrid, Spain, 34Rheumatology, Rheumatolgy Unit. Hospital Jerez, Jerez, Spain, 35Pathology, Hospital Universitario Marqués de Valdecilla. IDIVAL, Santander, Spain

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: , ,

Session Information

Date: Sunday, November 8, 2015

Title: Miscellaneous Rheumatic and Inflammatory Diseases Poster I

Session Type: ACR Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose: Interleukin (IL)-1 and IL-6 are pivotal cytokines in the pathogenesis of adult-onset Still’s disease (AOSD). Our aim was to compare the efficacy and safety of tocilizumab (TCZ) versus anakinra (ANK) given for at least 1 year to AODS patients refractory to conventional treatment.

Methods: Multicenter study (31 hospitals) of 75 patients (TCZ; n=34 and ANK; n 41) with AODS refractory to conventional immunosuppressive drugs and in many cases also to other biological agents.

Results: Comparisons of the group of patients with TCZ and ANK were: a) Average age: 39±16 vs. 34±14 years (p=0.2) b) Percentage of women: 76.5% vs. 63.4% (p=0.2) c) Median disease duration 4.2 [1-9] vs. 2.2 [0.3 to 4.9] years (p=0.14) d) Average dose of prednisone 15±9.9 mg/day vs. 28.3±22 mg/day (p=0.013) e) Median of conventional

immunosuppressants (2 [1-3] vs 1 [1-2] (p=0.05) f) Median of other biological therapies: 1 [0-2] vs. 0 [0-1] (p=0.04). The initial dose of i.v. TCZ were: 8 mg/kg/4 weeks (n=22), 8 mg/kg/2 weeks (n=10) and 4 mg/kg/4 weeks (n=2). ANK dose was 100 mg/day s.c. Both biologic agents were often combined with a conventional immunosuppressive drug (55.9% vs 70.7%; p=0.2). Both biologi agents yielded a quick and sustained improvement of all clinical and laboratory parameters (Table). The improvement in the clinical parameters was similar in both groups. However an earlier improvement of CRP and ESR was observed following TCZ therapy. After a median follow-up of 19 months [12-31] with TCZ and 15.5 months [4.5 to 50] with ANK (p=0.1), the major adverse effects in the TCZ group were: elevation liver enzymes (n=4), mild to

moderate leucopenia (4), upper respiratory tract infection (3), pneumonia (1), pyelonephritis and severe enterocolitis (1) and spondylodiscitis (1). In the group of ANK: skin lesions (n=8), mild leucopenia (3), myopathy (1), respiratory infection by P. aeruginosa and gluteal abscess (1), herpes zoster (1), osteomyelitis (1) and infection of urinary tract (2). While none of the TCZ-treated required discontinuation of the drug due to inefficacy, ANK had to be discontinued for this reason in 11 patients (p=0.001). Adverse effects leading to discontinuation of the drug were observed in 2 patients with TCZ and 4 patients with ANK (p=0.54).

Conclusion: TCZ and ANK are associated with a rapid and sustained clinical improvement in most patients with refractory AODS. However, TCZ appears to be more effective than ANK.

TABLE. Clinical manifestations and laboratory parameters (patients with TCZ vs. ANK)

 

Basal

TCZ (34) /  ANK (41)

1 Month

TCZ (34) /  ANK (41)

3  Months

TCZ (34) /  ANK (37)

6  Months

TCZ (34) /  ANK (32)

12  Months

TCZ (32) /  ANK (27)

Fever, %

58.8 / 78 #

5.9 / 17.1

5.9 / 10.8

5.9 / 0

5.9 / 7.4

Articular, %

97.1 / 87.8

67.6 / 48.7

44.1 / 34.1

26.5 / 28.1

32.4 / 29.6

Rash,%

58.8 / 58.5 

5.9 / 9.8

5.9 /10.8

5.9 / 0

5.9 / 3.7

Lymphadenopathy and/or visceromegalies, %

25 / 39

19 / 23

0 / 14

0 / 6

0 / 4

CRP (mg/dl) median [IQR]

8.9 [3.9-23.2] / 8.9 [4.4-14.9]

0.2 [0.1-1.6] / 1.1 [0.13-3.8] *

0.1 [0.01-0,7] / 0.62 [0.1-1.5] *

0.2 [0.01-0.9] / 0.5 [0.2-1.3] *

0.2 [0.03-1.1] / 0.3 [0.06-1.3] *

ESR 1st hr, median [IQR]

52 [45-69] / 60.5 [39-87]

4 [2-12] / 16.5 [10-37] *

4 [2-9] / 16 [6-30] *

4 [2-8] / 8 [4-20] *

2 [2-12] / 6 [2-18]

Leukocytes/mm3, mea± SD

13534±6023  / 15121±7752

8983±4550  / 8101±3655

8044±4360 / 7808±3002

7579±3588 / 7844±2297

8683±3658 / 7843±2703

Anemia, Hb (g/dl), mean±SD

11.9±1.36 / 10.9±2.07

12.9±1.2  / 12.2±2.03

13.3±1.1 / 12.86±2.13

13.3±1.3 / 13.37±1.6

14±1.3 / 13.7±1.5

Ferritin (ng/ml), median [IQR]

480 [200-808] / 998 [196-4212]

239 [39-358] / 456 [55-1182]

100 [73-132] / 121 [24-353]

107 [53-187] / 179 [52-339]

90 [63-115]  / 125 [58-253]

Disclosure: L. Riancho-Zarrabeitia, None; V. Calvo-Río, None; R. Blanco, None; J. L. Hernández, None; F. Ortiz-Sanjuán, None; A. Olivé, None; A. Riveros Frutos, None; S. Castañeda, None; J. Narváez, None; M. L. Velloso Feijoo, None; M. V. Hernández, None; A. Sifuentes Giraldo, None; O. Maiz-Alonso, None; E. Rubio Romero, None; C. Mata-Arnaiz, None; A. Gallego Flores, None; J. del Blanco, None; C. Gómez-Arango, None; S. Manrique-Arija, None; M. C. Ordoñez, None; I. Ros Vilamajo, None; M. A. Caracuel-Ruiz, None; M. Freire, None; J. Llobet, None; C. Marras, None; C. Moll Tuduri, None; C. Plasencia, None; R. Roselló, None; A. Urruticoechea, None; I. Jiménez-Moleón, None; J. A. Bernal, None; V. Ortiz-Santamaría, None; J. R. De Dios, None; M. Moreno, None; J. Fiter, None; M. de los Riscos, None; P. E. Carreira, None; M. J. Rodríguez Valls Sr., None; C. Gonzalez-Vela, None; J. Loricera, None; N. Palmou, None; M. A. Gonzalez-Gay, None.

To cite this abstract in AMA style:

Riancho-Zarrabeitia L, Calvo-Río V, Blanco R, Hernández JL, Ortiz-Sanjuán F, Olivé A, Riveros Frutos A, Castañeda S, Narváez J, Velloso Feijoo ML, Hernández MV, Sifuentes Giraldo A, Maiz-Alonso O, Rubio Romero E, Mata-Arnaiz C, Gallego Flores A, del Blanco J, Gómez-Arango C, Manrique-Arija S, Ordoñez MC, Ros Vilamajo I, Caracuel-Ruiz MA, Freire M, Llobet J, Marras C, Moll Tuduri C, Plasencia C, Roselló R, Urruticoechea A, Jiménez-Moleón I, Bernal JA, Ortiz-Santamaría V, De Dios JR, Moreno M, Fiter J, de los Riscos M, Carreira PE, Rodríguez Valls MJ Sr., Gonzalez-Vela C, Loricera J, Palmou N, Gonzalez-Gay MA. Tocilizumab Compared with Anakinra in Refractory Adult-Onset Still’s Disease. Multicenter Study of 75 Patients [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/tocilizumab-compared-with-anakinra-in-refractory-adult-onset-stills-disease-multicenter-study-of-75-patients/. Accessed .

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