Mónica Calderón-Goercke1, Javier Loricera1, Vicente Aldasoro2, Santos Castañeda3, Ignacio Villa4, Alicia Humbría3, Clara Moriano5, Susana Romero-Yuste6, Javier Narváez7, Catalina Gómez-Arango8, Eva Pérez-Pampín9, Rafael Melero10, Elena Becerra-Fernández11, Marcelino Revenga12, Noelia Álvarez-Rivas13, Carles Galisteo14, Francisca Sivera15, Alejandro Olivé-Marqués16, María Álvarez Del Buergo17, Luisa Marena-Rojas18, Carlos Fernández-López19, Francisco Navarro20, Enrique Raya21, Eva Galindez-Agirregoikoa22, Beatriz Arca23, Roser Solans-Laqué24, Arantxa Conesa25, Cristina Hidalgo26, Carlos Vázquez27, José Andrés Román-Ivorra28, Pau Lluch29, Sara Manrique-Arija30, Paloma Vela31, Eugenio De Miguel32, Carmen Torres-Martín33, Juan Carlos Nieto34, Carmen Ordas-Calvo35, Eva Salgado-Pérez36, Cristina Luna-Gomez37, F Javier Toyos-Sáenz de Miera38, Nagore Fernández-Llanio39, Antonio García40, Carmen Larena12, Natalia Palmou-Fontana1, Vanesa Calvo-Río1, Diana Prieto-Peña1, Carmen González-Vela1, Alfonso Corrales1, María Varela-García2, Elena Aurrecoechea4, Raquel Dos Santos9, Ángel García-Manzanares11, Norberto Ortego21, Sabela Fernández23, Francisco Ortiz-Sanjuán28, Montserrat Corteguera33, José L Hernández1, Miguel Á González-Gay41, Ricardo Blanco42. 1. Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain. 2. Department of Rheumatology, Complejo Hospitalario de Navarra, Navarra, Spain. 3. Department of Rheumatology, Hospital Universitario de La Princesa, IIS-Princesa, Madrid, Spain. 4. Department of Rheumatology, Hospital de Sierrallana, Torrelavega, Spain. 5. Department of Rheumatology, Complejo Asistencial Universitario de León, León, Spain. 6. Department of Rheumatology, Complejo Hospitalario Universitario Pontevedra, Spain. 7. Department of Rheumatology, Hospital de Bellvitge, Barcelona, Spain. 8. Department of Rheumatology, Hospital Alto Deba, Mondragón, Spain. 9. Department of Rheumatology, Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain. 10. Department of Rheumatology, Complexo Hospitalario Universitario de Vigo, Vigo, Spain. 11. Department of Rheumatology, Hospital Universitario de Torrevieja, Alicante, Spain. 12. Department of Rheumatology, Hospital Ramón y Cajal, Madrid, Spain. 13. Department of Rheumatology, Hospital Universitario Lucus Augusti, Lugo, Spain. 14. Department of Rheumatology, Hospital Parc Taulí, Barcelona, Spain. 15. Department of Rheumatology, Hospital Universitario de Elda, Alicante, Spain. 16. Department of Rheumatology, Hospital Trías i Pujol, Badalona, Spain. 17. Department of Rheumatology, Hospital Río Carrión, Palencia, Spain. 18. Department of Rheumatology, Hospital La Mancha Centro, Alcázar de San Juan, Spain. 19. Department of Rheumatology, Hospital Universitario Juan Canalejo, A Coruña, Spain. 20. Department of Rheumatology, Hospital General Universitario de Elche, Alicante, Spain. 21. Department of Rheumatology and Internal Medicine, Hospital San Cecilio, Granada, Spain. 22. Department of Rheumatology, Hospital de Basurto, Bilbao, Spain. 23. Department of Rheumatology, Hospital Universitario San Agustín, Avilés, Spain. 24. Department of Internal Medicine, Hospital Valle de Hebrón, Barcelona, Spain. 25. Department of Rheumatology, Hospital General Universitario de Castellón, Spain. 26. Department of Rheumatology, Complejo Asistencial Universitario de Salamanca, Spain. 27. Department of Rheumatology, Hospital Miguel Servet, Zaragoza, Spain. 28. Department of Rheumatology, Hospital Universitario y Politécnico La Fe, Valencia, Spain. 29. Department of Rheumatology, Hospital Mateu Orfila, Menorca, Spain. 30. Department of Rheumatology, Hospital Regional de Málaga, Málaga, Spain. 31. Department of Rheumatology, Hospital General Universitario de Alicante, Alicante, Spain. 32. Department of Rheumatology, Hospital La Paz, Madrid, Spain. 33. Department of Rheumatology, Complejo Asistencial de Ávila, Ávila, Spain. 34. Department of Rheumatology, Hospital Gregorio Marañón, Madrid, Spain. 35. Department of Rheumatology, Hospital Cabueñes, Gijón, Spain. 36. Department of Rheumatology, Complejo Hospitalario Universitario de Ourense, Ourense, Spain. 37. Department of Rheumatology, Hospital Universitario Nuestra Señora de la Candelaria, Tenerife, Spain. 38. Department of Rheumatology, Hospital Universitario Virgen Macarena, Sevilla, Spain. 39. Department of Rheumatology, Hospital Arnau de Vilanova, Lérida, Spain. 40. Department of Rheumatology, Hospital Virgen de las Nieves, Granada, Spain. 41. Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain. Electronic address: miguelaggay@hotmail.com. 42. Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain. Electronic address: rblanco@humv.es.
Abstract
OBJECTIVE: Tocilizumab (TCZ) has shown efficacy in clinical trials on giant cell arteritis (GCA). Real-world data are scarce. Our objective was to assess efficacy and safety of TCZ in unselected patients with GCA in clinical practice Methods: Observational, open-label multicenter study from 40 national referral centers of GCA patients treated with TCZ due to inefficacy or adverse events of previous therapy. Outcomes variables were improvement of clinical features, acute phase reactants, glucocorticoid-sparing effect, prolonged remission and relapses. A comparative study was performed: (a) TCZ route (SC vs. IV); (b) GCA duration (≤6 vs. >6 months); (c) serious infections (with or without); (d) ≤15 vs. >15 mg/day at TCZ onset. RESULTS: 134 patients; mean age, 73.0 ± 8.8 years. TCZ was started after a median [IQR] time from GCA diagnosis of 13.5 [5.0-33.5] months. Ninety-eight (73.1%) patients had received immunosuppressive agents. After 1 month of TCZ 93.9% experienced clinical improvement. Reduction of CRP from 1.7 [0.4-3.2] to 0.11 [0.05-0.5] mg/dL (p < 0.0001), ESR from 33 [14.5-61] to 6 [2-12] mm/1st hour (p < 0.0001) and decrease in patients with anemia from 16.4% to 3.8% (p < 0.0001) were observed. Regardless of administration route or disease duration, clinical improvement leading to remission at 6, 12, 18, 24 months was observed in 55.5%, 70.4%, 69.2% and 90% of patients. Most relevant adverse side-effect was serious infections (10.6/100 patients-year), associated with higher doses of prednisone during the first three months of therapy. CONCLUSION: In clinical practice, TCZ yields a rapid and maintained improvement of refractory GCA. Serious infections appear to be higher than in clinical trials.
OBJECTIVE:Tocilizumab (TCZ) has shown efficacy in clinical trials on giant cell arteritis (GCA). Real-world data are scarce. Our objective was to assess efficacy and safety of TCZ in unselected patients with GCA in clinical practice Methods: Observational, open-label multicenter study from 40 national referral centers of GCA patients treated with TCZ due to inefficacy or adverse events of previous therapy. Outcomes variables were improvement of clinical features, acute phase reactants, glucocorticoid-sparing effect, prolonged remission and relapses. A comparative study was performed: (a) TCZ route (SC vs. IV); (b) GCA duration (≤6 vs. >6 months); (c) serious infections (with or without); (d) ≤15 vs. >15 mg/day at TCZ onset. RESULTS: 134 patients; mean age, 73.0 ± 8.8 years. TCZ was started after a median [IQR] time from GCA diagnosis of 13.5 [5.0-33.5] months. Ninety-eight (73.1%) patients had received immunosuppressive agents. After 1 month of TCZ 93.9% experienced clinical improvement. Reduction of CRP from 1.7 [0.4-3.2] to 0.11 [0.05-0.5] mg/dL (p < 0.0001), ESR from 33 [14.5-61] to 6 [2-12] mm/1st hour (p < 0.0001) and decrease in patients with anemia from 16.4% to 3.8% (p < 0.0001) were observed. Regardless of administration route or disease duration, clinical improvement leading to remission at 6, 12, 18, 24 months was observed in 55.5%, 70.4%, 69.2% and 90% of patients. Most relevant adverse side-effect was serious infections (10.6/100 patients-year), associated with higher doses of prednisone during the first three months of therapy. CONCLUSION: In clinical practice, TCZ yields a rapid and maintained improvement of refractory GCA. Serious infections appear to be higher than in clinical trials.
Authors: Dan Pugh; Maira Karabayas; Neil Basu; Maria C Cid; Ruchika Goel; Carl S Goodyear; Peter C Grayson; Stephen P McAdoo; Justin C Mason; Catherine Owen; Cornelia M Weyand; Taryn Youngstein; Neeraj Dhaun Journal: Nat Rev Dis Primers Date: 2022-01-06 Impact factor: 65.038
Authors: Sebastian Unizony; Timothy J McCulley; Robert Spiera; Jinglan Pei; Paris N Sidiropoulos; Jennie H Best; Christine Birchwood; Andrey Pavlov; John H Stone Journal: Arthritis Res Ther Date: 2021-01-06 Impact factor: 5.156
Authors: Michael Behal; Brooke Barlow; Breanne Mefford; Melissa L Thompson Bastin; J Chris Donaldson; Melanie Laine; Brittany D Bissell Journal: Crit Care Explor Date: 2021-07-13
Authors: Diana Prieto-Peña; Pilar Bernabeu; Paloma Vela; Javier Narváez; Jesús C Fernández-López; Mercedes Freire-González; Beatriz González-Álvarez; Roser Solans-Laqué; José L Callejas Rubio; Norberto Ortego; Carlos Fernández-Díaz; Esteban Rubio; Salvador García-Morillo; Mauricio Minguez; Cristina Fernández-Carballido; Eugenio de Miguel; Sheila Melchor; Eva Salgado; Beatriz Bravo; Susana Romero-Yuste; Juan Salvatierra; Cristina Hidalgo; Sara Manrique; Carlos Romero-Gómez; Patricia Moya; Noelia Álvarez-Rivas; Javier Mendizabal; Francisco Ortiz-Sanjuán; Iván Pérez de Pedro; José L Alonso-Valdivielso; Laura Perez-Sanchez; Rosa Roldán; Nagore Fernandez-Llanio; Ricardo Gómez de la Torre; Silvia Suarez; María Jesús Montesa Cabrera; Mónica Delgado Sánchez; Javier Loricera; Belén Atienza-Mateo; Santos Castañeda; Miguel A González-Gay; Ricardo Blanco Journal: Ther Adv Musculoskelet Dis Date: 2021-06-18 Impact factor: 5.346
Authors: Wolfgang A Schmidt; Bhaskar Dasgupta; Raashid Luqmani; Sebastian H Unizony; Daniel Blockmans; Zhihong Lai; Regina H Kurrasch; Ivana Lazic; Kurt Brown; Ravi Rao Journal: Rheumatol Ther Date: 2020-08-25