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Observational Study
. 2021 Apr;51(2):387-394.
doi: 10.1016/j.semarthrit.2021.01.006. Epub 2021 Jan 27.

Tocilizumab in refractory giant cell arteritis. Monotherapy versus combined therapy with conventional immunosuppressive drugs. Observational multicenter study of 134 patients

Mónica Calderón-Goercke  1 , Santos Castañeda  2 , Vicente Aldasoro  3 , Ignacio Villa  4 , Clara Moriano  5 , Susana Romero-Yuste  6 , Javier Narváez  7 , Catalina Gómez-Arango  8 , Eva Pérez-Pampín  9 , Rafael Melero  10 , Elena Becerra-Fernández  11 , Marcelino Revenga  12 , Noelia Álvarez-Rivas  13 , Carles Galisteo  14 , Francisca Sivera  15 , Eugenio De Miguel  16 , Diana Prieto-Peña  1 , Miguel Á González-Gay  1 , José L Hernández  17 , Ricardo Blanco  1 ; Tocilizumab in Giant Cell Arteritis Spanish Collaborative Group
Affiliations
Observational Study

Tocilizumab in refractory giant cell arteritis. Monotherapy versus combined therapy with conventional immunosuppressive drugs. Observational multicenter study of 134 patients

Mónica Calderón-Goercke et al. Semin Arthritis Rheum. 2021 Apr.

Abstract

Objective: To compare the efficacy and safety of TCZ in monotherapy (TCZMONO) vs. combined with conventional immunosuppressive drugs (TCZCOMBO) in Giant Cell Arteritis (GCA) in a clinical practice scenario.

Methods: Multicenter study of 134 patients with refractory GCA. Patients on TCZMONO (n = 82) were compared with those on TCZCOMBO (n = 52). Drugs were methotrexate (MTX) (n = 48), azathioprine (n = 3), and leflunomide (n = 1). The main outcomes were: prolonged remission (normalization of clinical and laboratory parameters for at least 6 months) and the number of relapses.

Results: Patients on TCZCOMBO were younger (68.8 ± 8.0 vs 71.2 ± 9.0 years; p = 0.04), with a trend to a longer GCA duration (median [IQR],18.5 [6.25-34.0] vs. 13.0 [7.75-33.5] months; p = 0.333), higher C-reactive protein (CRP) levels (2.1[1-4.7] vs 1.2 [0.2-2.4] mg/dL; p = 0.003), and more prevalence of extra-cranial large-vessel vasculitis (LVV) (57% vs. 34.1%; p = 0.007). In both groups, rapid and sustained improvement was observed. Despite the longer GCA duration, and the higher CRP levels and prevalence of LVV in the TCZCOMBO, the improvement was similar in both groups at 12 months. Moreover, in the TCZCOMBO group, prolonged remission was significantly higher at 12-month. Relapses and serious adverse events were similar in both groups.

Conclusion: In clinical practice, TCZ in monotherapy or combined with conventional immunosuppressive agents is effective and safe in patients with GCA. Nevertheless, the addition of immunosuppressive drugs, usually MTX, seems to allow a higher rate of prolonged remission, even in patients with a longer GCA duration, more extra-cranial LVV involvement, and higher acute-phase reactants.

Keywords: Cranial arteritis; Giant cell arteritis; Immunosuppressive drugs; Monotherapy; Tocilizumab.

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Conflict of interest statement

Declaration of Competing Interest Disclosures that might be interpreted as constituting possible conflict(s) of interest for the study: Dr. Mónica Calderón-Goercke attendance at conferences Lilly, Abbvie, and Pfizer. Dr. S. Castañeda is assistant professor, cátedra EPID-Future, funded by UAM-Roche, Universidad Autónoma de Madrid (UAM). Dr. Vicente Aldasoro had consultation fees/participation in company-sponsored speaker´s bureau from Janssen, BMS, MSD, Roche, Sanofi, Pfizer, Novartis, Amgen, Lilly, Abbvie, Gebro, Nordic, Lacer, Alter, UCB, ASAC Pharma, Menarini and Celgene. Dr. Eva Pérez-Pampín had consultation fees/participation in company-sponsored speaker´s bureau from MSD, BMS, Janssen, Abbvie, Novartis, Pfizer, Roche, UCB, Lilly, Celgene, and Nordic. Dr. Francisca Sivera received grants from Roche. Dr. Eugenio De Miguel had consultation fees/participation in company-sponsored speaker´s bureau from Abbvie, Novartis, Pfizer, BMS, MSD, UCB, Roche, Grünenthal and Janssen. Dr. Diana Prieto-Peña attendance at conferences Lilly, Roche, and Pfizer. Prof. José L. Hernández received grants from Amgen and had participation in company-sponsored speaker´s bureau from Amgen, MSD, Bayer, and Esteve. Dr. MA Gonzalez-Gay received grants/research supports from Abbvie, MSD, and Roche, and had consultation fees/participation in company-sponsored speaker´s bureau from Pfizer, Celgene, Novartis, Roche, Sanofi, and Lilly. Dr. R Blanco received grants/research supports from Abbvie, MSD, and Roche, and had consultation fees/participation in company-sponsored speaker´s bureau from Abbvie, Pfizer, Roche, BMS, Janssen, and MSD. No financial disclosures declared: Ignacio Villa, Clara Moriano, Susana Romero-Yuste, Javier Narváez, Catalina Gómez-Arango, Rafael Melero, Elena Becerra-Fernández, Marcelino Revenga, Noelia Álvarez-Rivas, and Carles Galisteo.

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