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Abstract Number: 814

Tocilizumab in Giant Cell Arteritis: Multicenter Open-Label Study of 22 Patients

Montserrat Santos-Gómez1, Javier Loricera1, Ricardo Blanco1, Jose L. Hernández2, Antonio Mera3, Eva Pérez-Pampin4, M. Enriqueta Peiró1, Santos Castañeda-Sanz5, Alicia Humbría6, Jaime Calvo-Alen7, Elena Aurrecoechea8, Javier Narváez9, Amalia Sánchez-Andrade10, Paloma Vela11, Elvira Díez Álvarez12, Cristina Mata13, Pablo Lluch Mesquida14, Concepcion Moll Tuduri14, Vanesa Calvo-Río1, Francisco Ortiz-Sanjuán1, Trinitario Pina Murcia15, Carmen Gonzalez-Vela16, Leyre Riancho-Zarrabeitia1 and Miguel A. González-Gay1, 1Rheumatology, Hospital Universitario Marqués de Valdecilla. IDIVAL. Santander. Spain, Santander, Spain, 2Internal Medicine, Hospital Universitario Marqués de Valdecilla. IDIVAL. Santander. Spain, Santander, Spain, 3Hospital Clínico Universitario de Santiago de Compostela. Spain, Santiago de Compostela, Spain, 4Rheumatology, Hospital Clínico Universitario de Santiago de Compostela. Spain, Santiago de Compostela, Spain, 5Rheumatology, Hospital Universitario de La Princesa. Madrid. Spain, Madrid, Spain, 6Rheumatology, Hospital Universitario de La Princesa. IIS-Princesa, Madrid, Madrid, Spain, 7Rheumatology, Hospital de Sierrallana. Torrelavega. Spain, Torrelavega, Spain, 8Hospital de Sierrallana. Torrelavega. Spain, Torrelavega, Spain, 9Rheumatology, Hospital Universitario de Bellvitge. Barcelona. Spain, Barcelona, Spain, 10Rheumatology, Hospital Universitario Lucus Augusti. Lugo. Spain, Lugo, Spain, 11Rheumatology, Hospital General de Alicante. Spain, Alicante, Spain, 12Rheumatology, Hospital de León. Spain, León, Spain, 13Rheumatology, Hospital Comarcal de Laredo. Spain, Laredo, Spain, 14Hospital Mateu Orfila. Menorca. Spain, Mahón (Menorca), Spain, 15Epidemiology, Genetics and Atherosclerosis Research Group on Systemic Inflammatory Diseases, Rheumatology Division, IDIVAL, Santander, Spain, 16Pathology, Hospital Universitario Marqués de Valdecilla. IDIVAL. Santander. Spain, Santander, Spain

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: giant cell arteritis, IL-6R signaling, tocilizumab and vasculitis

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Session Information

Session Title: Vasculitis

Session Type: Abstract Submissions (ACR)

Background/Purpose

 Giant cell arteritis (GCA) is a primary vasculitis that involves the aorta and its major branches. It usually affects people aged more than 50 years. GCA may be refractory to standard therapy with corticosteroids that, in turn, may be associated with substantial adverse events. Tocilizumab (TCZ) has demonstrated efficacy in single cases or in small series of patients with GCA. Our aim was to assess the efficacy and side-effects of TCZ in a multicenter study of patients with refractory GCA.

Methods

Multicenter open-label study of patients with refractory GCA. TCZ was used because of inadequate response to corticosteroids and in most cases to other therapies. All the patients meet the 1990 ACR criteria for GCA. TCZ therapy was used at standard dose of 8 mg/kg/monthly.

Results:

22 patients (17 women/ 5 men; mean age±SD was 69±8 years) were assessed. Sixteen (73%) of them had a positive temporal artery biopsy. The main clinical features at the time of TCZ onset were: polymyalgia rheumatica (n=15), asthenia (n=7), headache (n=5), constitutional syndrome (n=4), jaw claudication (n=2), visual manifestations (n=2), claudication of the lower limbs (n=1), chest pain (n=1), arthritis (n=1), dyspnea (n=1) and scapular pain (n=1). Fifteen patients also had aortitis. Besides corticosteroids and before TCZ therapy, 19 patients had received several traditional immunosuppressive agents: methotrexate (n=19), azathioprine (n=1) and leflunomide (n=1). In addition, 2 patients had also been treated with other biologic agents before starting on TCZ. One patient received etanercept that was switched to TCZ due to inefficacy. Another patient received infliximab that was switched to rituximab, then to abatacept and finally to TCZ because of inefficacy. Most patients experienced clinical and laboratory improvement within the first 3 months after the onset of TCZ (TABLE). After a median [IQR 25th-75th] follow-up of 6 [3-16] months, the erythrocyte sedimentation rate decreased from a median value of 44 [20-81] to 12 [3-20] mm/1st hour. Similarly, C-reactive protein levels also decreased from a median initial value of 1.9 [1.2-5.4] to 0.2 [0.1-0.9] mg/dL. A corticosteroid sparing effect was also achieved (from a median [IQR] prednisone dose of 18.75 [10-45] mg/day at TCZ onset to 5 [0-7.5] mg/day at last visit). In 3 patients TCZ was discontinued due to severe neutropenia (351 neutrophils/mm3); recurrent pneumonia; and cytomegalovirus infection, respectively. Also, one patient died after the second infusion of TCZ as the result of a stroke in the setting of an infectious endocarditis.

Conclusion

In our series, TCZ seems to be effective in the treatment of GCA refractory to corticosteroids and other immunosuppressive agents.

TABLE


Clinical Manifestations

Basal*

Month 3*

Month 6*

Month 12*

      Polymyalgia rheumatica, %

68

0*

0 *

0 *

      Constitutional syndrome, %

18

0 *

0 *

0 *

      Headache, %

23

10 *

0 *

0 *

Laboratory parameters, median [IQR]

      ESR

44 [20-81]

4 [2-17] *

4 [3-9] *

14.5 [8-30] *

      CRP

1.9 [1.2-5.4]

0.1 [0.1-0.3] *

0.1 [0.1-0.2] *

0.3 [0.1-1.8] *

Prednisone dose (mg/day) , median [IQR]

18.75 [10-45]

9.37 [5-10] *

5 [5-6.25] *

2.5 [0-5] *

*p<0.05 compare to baseline


Disclosure:

M. Santos-Gómez,
None;

J. Loricera,
None;

R. Blanco,
None;

J. L. Hernández,
None;

A. Mera,
None;

E. Pérez-Pampin,
None;

M. E. Peiró,
None;

S. Castañeda-Sanz,
None;

A. Humbría,
None;

J. Calvo-Alen,
None;

E. Aurrecoechea,
None;

J. Narváez,
None;

A. Sánchez-Andrade,
None;

P. Vela,
None;

E. Díez Álvarez,
None;

C. Mata,
None;

P. Lluch Mesquida,
None;

C. Moll Tuduri,
None;

V. Calvo-Río,
None;

F. Ortiz-Sanjuán,
None;

T. Pina Murcia,
None;

C. Gonzalez-Vela,
None;

L. Riancho-Zarrabeitia,
None;

M. A. González-Gay,
None.

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