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Objective: To compare the efficacy of TNF inhibitors (adalimumab (ADA) and infliximab (IFX)) vs tocilizumab (TCZ) in patients with refractory cystoid macular edema (CME) due to Behçet's disease (BD)., Methods: Multicenter study of patients with BD-associated CME refractory to conventional and/or biological immunosuppressive drugs. From a cohort of 177 patients treated with anti-TNF and 14 patients treated with TCZ, we selected those with CME at baseline. We analyzed the evolution of macular thickness (main outcome), best-corrected visual acuity (BCVA) and intraocular inflammation (Tyndall and vitritis) from baseline up to 4 years in the 3 groups mentioned., Results: 49 patients and 72 eyes with CME were included. ADA was used in 25 patients (40 eyes), IFX in 15 (21 eyes) and TCZ in 9 (11 eyes). No statistically significant baseline differences were observed between the 3 groups except for a lower basal BCVA in TCZ group and a higher basal degree of intraocular inflammation in ADA group. Most patients from all groups had received several conventional immunosuppressive drugs. In addition, most patients in the group of TCZ had also received anti-TNF agents. Biological therapy was used in monotherapy (n=8) or combined with conventional immunosuppressive drugs (n=41). Macular thickness progressively decreased in the 3 groups, with no signs of CME after 1 year of treatment. Similarly, BCVA improvement and inflammatory intraocular remission was achieved in all groups., Conclusion: Refractory CME associated with BD uveitis can be effectively treated either with ADA, IFX or TCZ. Furthermore, TCZ is effective in patients resistant to anti-TNF therapy., Competing Interests: Declaration of Competing Interest Disclosures that might be interpreted as constituting of possible conflict(s) of interest for the study: B. Atienza-Mateo received grants/research supports from Abbvie and Roche and had consultation fees/participation in company-sponsored speaker´s bureau from Pfizer, Celgene, Novartis, Sanofi, Janssen, UCB and Lilly. I. Ferraz-Amaro has received grants/research supports from Abbott, MSD, Jansen and Roche and had consultation fees/participation in company-sponsored speaker´s bureau from Abbott, Pfizer, Roche, Sanofi, Sobi, Amgen, Celgene and MSD. D. Prieto-Peña is supported by a research contract from the Carlos III Health Institute of Spain (Río Hortega program, ref. CM20/00006) and has received research support from UCB Pharma, Roche, Sanofi, Pfizer, Jansen, Amgen, AbbVie, Novartis and Lilly. A. Adán received grants/research supports from Abbvie and UCB. M. Cordero-Coma had consultation fees/participation in company-sponsored speaker´s bureau from Abbvie, Merck Sharp & Dohme, Allergan and UCB. He also participated in Advisory Boards from Abbvie and Allergan. He also had travel grants from Abbvie, UCB and Allergan. J.M. Nolla received grants/research supports from BMS, Galápagos, Kern, Lilly and UCB. V. Calvo-Río had consultation fees/participation in company-sponsored speaker's bureau from AbbVie, Lilly, MSD, UCB Pharma, Grünenthal Pharma and Celgene. S. Castañeda has received grants/research support from Amgen, MSD and Pfizer, and has received consultation fees in company sponsored speaker's bureau from Amgen, Bristol-Myers-Squibb, Grünenthal Pharma, Janssen, Lilly, MSD, Novartis, Sanofi, Sobi, Stata and UCB. S. Castañeda is also associated professor of the UAM-Roche chair, EPID-Future, Department of Medicine, Universidad Autónoma de Madrid, Madrid, Spain. Miguel A. González-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. 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, Lilly and MSD. No financial disclosure declared: N. Barroso-García, E. Beltrán, M. Hernández-Garfella, L. Martínez-Costa, M. Díaz-Llopis, J.M. Herreras, O. Maíz-Alonso, I. Torre-Salaberri, A. De Vicente-Delmás, D. Díaz-Valle, A. Atanes-Sandoval, F. Francisco, S. Insua, J. Sánchez, R. Almodóvar-González, A. Jiménez-Sosa, O. Ruiz-Moreno, M. Gandía Martínez., (Copyright © 2022. Published by Elsevier Inc.)

Objective: To compare the efficacy and safety of TCZ in monotherapy (TCZ MONO ) vs. combined with conventional immunosuppressive drugs (TCZ COMBO ) in Giant Cell Arteritis (GCA) in a clinical practice scenario., Methods: Multicenter study of 134 patients with refractory GCA. Patients on TCZ MONO (n = 82) were compared with those on TCZ COMBO (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 TCZ COMBO 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 TCZ COMBO , the improvement was similar in both groups at 12 months. Moreover, in the TCZ COMBO 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., Competing Interests: 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., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objective: To determine whether giant cell arteritis (GCA) patients with the typical pattern of cranial ischemic manifestations and those with the extracranial large-vessel-vasculitis (LVV)-GCA phenotype exhibit different HLA-DRB1 association., Methods: 178 biopsy-proven GCA patients who had cranial ischemic features but no LVV manifestations, 100 patients with LVV-GCA without cranial ischemic manifestations and 486 ethnically matched healthy controls were recruited. All patients and controls were Spanish of European ancestry. We compared HLA-DRB1 phenotype frequencies between the three groups., Results: Both GCA subgroups had well-differentiated clinical features. Patients with LVV-GCA were younger (68.0 ± 10.0 years versus 74.0 ± 10.4 years; p < 0.01) and presented more commonly with polymyalgia rheumatica symptoms (81% versus 39.3%; p < 0.01) than those with the classic cranial GCA phenotype. HLA-DRB1*04 phenotype frequency was significantly increased in patients with classic cranial GCA compared to controls (42.1% versus 23.5%, respectively; p < 0.01; odds ratio-OR [95% confidence interval-CI] = 2.38 [1.62-3.47]). This association was mainly due to the HLA-DRB1*04:01 allele (20.8% versus 5.3%, respectively; p < 0.01; OR [95% CI] = 4.64 [2.63-8.26]). HLA-DRB1*04 association was also observed in LVV-GCA patients when compared to controls (46.0% versus 23.5%, respectively; p < 0.01; OR [95% CI] = 2.78 [1.73-4.44]). Similar to cranial GCA, the association was also mainly due to the HLA-DRB1*04:01 allele (19.0% versus 5.3%, respectively; p < 0.01; OR [95% CI] = 4.15 [2.06-8.19]). Cranial and LVV-GCA patients did not exhibit HLA-DRB1 allele differences., Conclusion: Cranial and extracranial LVV-GCA share similar HLA-DRB1 association., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2020 Elsevier Inc. All rights reserved.)

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., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objective: Polymyalgia rheumatica (PMR) is often the presenting manifestation of giant cell arteritis (GCA). Fluorine-18-fluorodeoxyglucose positron emission tomography/computed tomography (PET/CT) scan often discloses the presence of large vessel vasculitis (LVV) in PMR patients. We aimed to identify predictive factors of a positive PET/CT scan for LVV in patients classified as having isolated PMR according to well-established criteria., Methods: A set of consecutive patients with PMR from a single hospital were assessed. All of them underwent PET/CT scan between January 2010 and February 2018 based on clinical considerations. Patients with PMR associated to other diseases, including those with cranial features of GCA, were excluded. The remaining patients were categorized in classic PMR (if fulfilled the 2012 EULAR/ACR classification criteria at disease diagnosis; n = 84) or atypical PMR (who did not fulfill these criteria; n = 16). Only information on patients with classic PMR was assessed., Results: The mean age of the 84 patients (51 women) with classic PMR was 71.4 ± 9.2 years. A PET/CT scan was positive in 51 (60.7%). Persistence of classic PMR symptoms was the most common reason to perform a PET/CT scan. Nevertheless, patients with positive PET/CT scan often had unusual symptoms. The best set of predictors of a positive PET/CT scan were bilateral diffuse lower limb pain (OR = 8.8, 95% CI: 1.7-46.3; p = 0.01), pelvic girdle pain (OR = 4.9, 95% CI: 1.50-16.53; p = 0.01) and inflammatory low back pain (OR = 4.7, 95% CI: 1.03-21.5; p = 0.04)., Conclusion: Inflammatory low back pain, pelvic girdle and diffuse lower limb pain are predictors of positive PET/CT scan for LVV in PMR., (Copyright © 2018 Elsevier Inc. All rights reserved.)