ObjectivesTo assess the efficacy of Tocilizumab (TCZ) in refractory thyroid associated orbitopathy (TAO) due to Grave’s disease.MethodsMulticenter study of 29 patients with TAO refractory to conventional immunosuppressive therapy.ResultsWe studied 29 patients (58 eyes) (23 women/6 men); mean age at diagnosis 48.79±12.39 years. Besides oral corticosteroids and before the onset of TCZ, patients had been treated with pulses of intravenous methylprednisolone (n=24), methotrexate (n=2) and other drugs (methimazole in 4 cases, leflunomide in 1, selenium in 9). Urgent decompressive surgery had to be performed in 2 patients.According to the classification of severity of the EUGOGO group (European Group on Graves’ Orbitopathy) using the clinical activity score (CAS), before TCZ onset patients whose data were available had severe (n=14 eyes) or moderate (n=22 eyes) disease. Moreover, patients presented exophthalmos (n=30 eyes), strabismus (n=17 eyes), muscle fibrosis (n=15 eyes) and dysthyroid optic neuropathy (n=1).TCZ was used in monotherapy (n=27) or combined with methotrexate (n=2) at 8 mg/kg/iv/4 weeks (n=24) or 162 mg/sc/week (n=5). TCZ yielded rapid and maintained improvement in all ocular parameters (TABLE).After a mean follow-up of 8.96±7.55 months using TCZ, all patients experienced ocular improvement, with TCZ withdrawal in 16 cases due to complete remission (n=5) or stability of ocular inflammation (n=11). Only 4 adverse effects were observed (neutropenia, external otitis, otitis media, costal osteitis).TABLE. Improvement of ocular parameters with TCZ therapy. Data are expressed as mean±SD or median[IQR].BASAL1 WEEK2 WEEKS1 MONTH3 MONTHS6 MONTHS1 YEAR VA0.7 [0.5–1]0.7 [0.6–1]0.8 [0.7–1]0.85 [0.7–1]1 [0.9–1]1 [0.7–1]1 [0.8–1]IOP19.22±4.2017.25±1.9016.75±2.3118.23±5.0017.39±3.5116.52±3.5616.00±3.41CAS4.97±1.724.85±2.95-3.40±2.282.34±1.711.29±1.121.11±0.85VA=visual acuity; IOP=intraocular pressure; CAS=clinical activity score (0/7 at baseline, 0/10 in the rest of time measures).ConclusionsTCZ appears to be useful in TAO treatment.Reference[1] Bartalena L, Baldeschi L, Dickinson AJ, et al. Consensus statement of the European group on Graves’ orbitopathy (EUGOGO) on management of Graves’ orbitopathy. Thyroid2008;18(3):333–346.Disclosure of InterestNone declared
Background:Interstitial Lung Disease (ILD) is a severe extraarticular manifestation of rheumatoid arthritis (RA). In this line, several radiological patterns of RA-ILD have been described: i) usual interstitial pneumonia (UIP), ii) nonspecific interstitial pneumonia (NSIP), iii) obliterating bronchiolitis, iv) organized pneumonia and mixed patterns. Abatacept (ABA) could be an effective and safe option for patients with RA-ILD, although the response in the different radiological patterns is not well defined.Objectives:Our aim was to assess the response to ABA in different radiological patterns of ILD.Methods:Observational retrospective multicenter study of RA-ILD treated with ABA. ILD was diagnosed by HRCT and classified by radiological patterns in 3 different subgroups of RA-ILD: a) UIP, b) NSIP and c) “other”. ABA was used sc. or iv. at standard dose. We assessed: a) Dyspnoea (MMRC scale; significant variation ≥1); b) Respiratory function tests (significant changes ≥10% in FVC and DLCO); c) HRCT imaging; d) DAS28 e)prednisone dose.Variables were collected at months 0, 3, 6, 12 months and subsequently every 12 months until a maximum of 60 months.Results:We included 263 patients: 106 UIP, 84 NSIP and 73 others (150 women / 113 men), mean age 64.64±10 years. Total patients positive for RF or CCPA were 235 (89.4%) and 233 (88.6%), respectively. In 26 out of 263 patients, the development of ILD was closely related to the administration of sDMARDs (MTX n = 11 and LFN n = 1) or bDMARDs (ETN n = 5, ADA n = 4, CZP n = 2 and IFX n = 3). Patient characteristics are shown in table 1. Figure 1 shows the evolution of the cases with available data after a mean follow-up of 22.7±19.7 months. Mean DLCO and FVC remained stable in the 3 groups without statistically significant changes, and all the groups showed a statistically significant reduction in DAS28 and prednisone dose.Conclusion:ABA could be a good choice of treatment in patients with RA-ILD independently of the radiological pattern of ILD.Disclosure of Interests:Carlos Fernández-Díaz Speakers bureau: Brystol Meyers Squibb, Santos Castañeda: None declared, Rafael Melero: None declared, J. Loricera: None declared, Francisco Ortiz-Sanjuán: None declared, A. Juan-Mas: None declared, Carmen Carrasco-Cubero Speakers bureau: Janssen, MSD, AbbVie, Novartis, Bristol Myers Squibb, and Celgene, S, Rodriguéz-Muguruza: None declared, S. Rodrigez -Garcia: None declared, R. Castellanos-Moreira: None declared, RAQUEL ALMODOVAR Speakers bureau: Abbvie, Celgene, Janssen, Lilly, Novartis, Pfizer., CLARA AGUILERA CROS: None declared, Ignacio Villa-Blanco Consultant of: UCB, Speakers bureau: Novartis, MSD, Lilly, Sergi Ordoñez: None declared, Susana Romero-Yuste: None declared, C. Ojeda-Garcia: None declared, Manuel Moreno: None declared, Gemma Bonilla: None declared, I. Hernández-Rodriguez: None declared, Mireia Lopez Corbeto: None declared, José Luis Andréu Sánchez: None declared, Trinidad Pérez Sandoval: None declared, Alejandra López Robles: None declared, Patricia Carreira Grant/research support from: Actelion, Roche, MSD, Consultant of: GlaxoSmithKline, VivaCell Biotechnology, Emerald Health Pharmaceuticals, Boehringer Ingelheim, Roche, Speakers bureau: Actelion, GlaxoSmithKline, Roche, Natalia Mena-Vázquez: None declared, C. Peralta-Ginés: None declared, ANA URRUTICOECHEA-ARANA: None declared, Luis Marcelino Arboleya Rodríguez: None declared, J. Narváez: None declared, DESEADA PALMA SANCHEZ: None declared, Olga Maiz-Alonso: None declared, J. Fernández-Leroy: None declared, I. Cabezas-Rodriguez: None declared, Ivan Castellví Consultant of: Boehringer Ingelheim, Actelion, Kern Pharma, Speakers bureau: Boehringer Ingelheim, Actelion, Bristol-Myers Squibb, Roche, A. Ruibal-Escribano: None declared, JR De Dios-Jiménez Aberásturi: None declared, Paloma Vela-Casasempere: None declared, C. González-Montagut Gómez: None declared, J M Blanco: None declared, Noelia Alvarez-Rivas: None declared, N. Del-Val: None declared, M. Rodíguez-Gómez: None declared, Eva Salgado-Pérez: None declared, Carlos Fernández-López: None declared, E.C. Cervantes Pérez: None declared, A. Devicente-DelMas: None declared, Blanca Garcia-Magallon Consultant of: MSD, Speakers bureau: Pfizer, Amgen, Celgene, MSD, Cristina Hidalgo: None declared, Sabela Fernández: None declared, R. López-Sánchez: None declared, Edilia García-Fernández: None declared, S. Castro: None declared, P. Morales-Garrido: None declared, Andrea García-Valle: None declared, Rosa Expósito: None declared, L. Exposito-Perez: None declared, Lorena Pérez Albaladejo: None declared, Ángel García-Aparicio: None declared, Miguel A González-Gay Grant/research support from: Pfizer, Abbvie, MSD, Speakers bureau: Pfizer, Abbvie, MSD, Ricardo Blanco Grant/research support from: AbbVie, MSD, and Roche, Speakers bureau: AbbVie, Pfizer, Roche, Bristol-Myers, Janssen, and MSD
Background:Infliximab and adalimumab therapy has significantly improved the prognosis of patients with non-infectious refractory uveitis. However, there is not enough evidence for the use of other anti-TNF drugs such as Certolizumab Pegol (CZP).Objectives:To evaluate the efficacy and safety of CZP in uveitis secondary to Immune-Mediated Inflammatory Diseases (IMID).Methods:Multicenter study of 39 patients with uveitis due to IMID refractory to glucocorticoids and conventional immunosuppressants. Efficacy of CZP was evaluated with the following ocular parameters: best corrected visual acuity (BCVA), anterior chamber cells, macular thickness and presence of retinal vasculitis. Efficacy of CZP was compared between baseline, 1st week, 1st and 6th month, and 1st and 2nd year. Statistical analysis was performed with the STATISTICA software (Statsoft Inc. Tulsa, Oklahoma, USA).Results:39 patients/56 affected eyes (18 men/21 women) with a mean age of 40.5±11.9 years were studied. IMIDs included were: spondyloarthritis (n=17), psoriatic arthritis (6), Crohn (3), JIA (2), Behçet (2), reactive arthritis (2), rheumatoid arthritis (1), relapsing polychondritis (1), pars planitis (1), Birdshot (1) and idiopathic uveitis (3). Uveitis pattern was as follows: anterior (n=30), posterior (4), panuveitis (3) and intermediate (2).Previous CZP, patients received: oral prednisone (n=18) methylprednisolone bolus (1), methotrexate (22), azathioprine (10), cyclosporine (4), leflunomide (2), mycophenolate mofetil (2) and cyclophosphamide (1). 77% of patients had received previous biological therapy, with a mean of 1.6±1.2 biological drugs per patient. Gestational desire was the reason for prescribing CZP in 8 patients. CZP was administered in monotherapy in 16 patients and in the remaining 23 patients combined with conventional immunosuppressants.After a median follow-up of 24 [6-36] months, most of the ocular variables analysed showed a rapid and significantly sustained improvement (Table). CZP was discontinued in 11 patients for the following reasons: remission (n=1), insufficient response of ocular symptoms (n=1) and limited response of extraocular manifestations (n=9). No serious adverse effects were reported.Conclusion:CZP seems to be effective and safe in patients with refractory uveitis due to IMID.TableBaseline1stweek1stMonth6thMonth1styear2ndyearBCVA (mean±SD)0.77±0.290.77±0.30*0.82±0.29*0.85±0.26*0.86±0.27*0.88±0.23*Tyndall (median [IQR])0 [0-2]0 [0-2]0 [0-1]*0 [0-0]*0 [0-0]*0 [0-0]*OCT (mean±SD)355±61.5-284.1±40.4*-224.8±121.1*-Retinal Vasculitis (eyes affected, %)2 (3.6)0 (0)0 (0)0 (0)0 (0)0 (0)*p<0.05Disclosure of Interests:José Luis Martín-Varillas Grant/research support from: AbbVie, Pfizer, Janssen and Celgene, Speakers bureau: Pfizer and Lilly, Vanesa Calvo-Río Grant/research support from: MSD and Roche, Speakers bureau: AbbVie, Lilly, Celgene, Grünenthal, UCB Pharma, Lara Sanchez-Bilbao Grant/research support from: Pfizer, Iñigo González-Mazón: None declared, Ignacio Torre-Salaberri: None declared, Álvaro García Martos: None declared, Amalia Sanchez-Andrade: None declared, Ángel García-Aparicio: None declared, JR De Dios-Jiménez Aberásturi: None declared, ANA URRUTICOECHEA-ARANA: None declared, Olga Maíz: None declared, Raul Veroz Gonzalez: None declared, Andrea García-Valle: None declared, Sergio Rodríguez Montero: None declared, Roberto Miguélez: None declared, Vega Jovani: None declared, Marisa Hernández-Garfella: None declared, Arantxa Conesa: None declared, Olga Martínez González: None declared, Paula Rubio Muñoz: None declared, Belén Atienza-Mateo: None declared, Miguel A González-Gay Grant/research support from: Pfizer, Abbvie, MSD, Speakers bureau: Pfizer, Abbvie, MSD, Ricardo Blanco Grant/research support from: AbbVie, MSD, and Roche, Speakers bureau: AbbVie, Pfizer, Roche, Bristol-Myers, Janssen, and MSD
BackgroundAdalimumab remains the only biologic approved by the EMA and FDA for the treatment of non-infectious uveitis [1-6]. The reports on efficacy of other anti-TNF drugs such as Certolizumab Pegol (CZP) are scarce.Objectivesto determine the efficacy and safety of CZP in refractory uveitis secondary to Immune-mediated Inflammatory Diseases (IMIDs).Methodsnational multicenter study of 80 patients with uveitis due to IMID refractory to glucocorticoids and conventional immunosuppressants treated with CZP. Efficacy was assessed with the following ocular parameters: best corrected visual acuity (BCVA), anterior chamber cells, vitritis, macular thickness and presence of retinal vasculitis. The efficacy of CZP was compared between the baseline visit, 1st week, 1st and 6th month, and 1st year. Statistical analysis was performed with IBM SPSS Statistics v.23.Resultswe studied 80 patients/111 affected eyes (33 men/47 women) with a mean age of 41.6±11.7 years. The IMIDs included were: spondyloarthritis (n=43), Behçet’s disease (10), psoriatic arthritis (8), Crohn’s disease (4), sarcoidosis (2), JIA (1), reactive arthritis (1), rheumatoid arthritis (1), relapsing polychondritis (1), TINU (1), pars planitis (1), Birdshot (1) and idiopathic uveitis (6). Anterior was the most frequent uveitis pattern (n=61).In 20 patients, besides the presence of refractory uveitis, desire of pregnancy was the reason for CZP initiation.Prior to CZP, patients had received: methotrexate (n=38), sulfasalazine (28), azathioprine (14), cyclosporine (10), leflunomide (3), mycophenolate mofetil (4), and cyclophosphamide (1). Previous biologic therapy was administered in 52 patients (63%), with a median [IQR] of 2 [1-3] drugs per patient. The most used biologic was adalimumab (n=48), followed by infliximab (32), golimumab (15), tocilizumab (5), etanercept (7), rituximab (1), anakinra (1) and secukinumab (1). CZP was administered as monotherapy in 39 patients.After 24 [12-36] months of follow-up, all parameters analyzed showed a rapid and maintained improvement (Table 1). A decrease in the mean number of uveitis flares was observed before and after CZP, (2.6±2.3 vs. 0.6±0.4, p<0.001). CZP was discontinued in 16 patients due to: ocular remission (n=3), insufficient ocular response (4) and incomplete response of extraocular manifestations (9). No serious adverse effects were found.Table 1.main ocular parameters analyzed in 80 patients with uveitis due to IMID and treated with CZP.Baseline1st week1st month3rd month6th month1st yearBCVA (mean±SD)0.68±0.270.73±0.26*0.79±0.26*0.82±0.25*0.85±0.24*0.86±0.23*Tyndall improvement, n (%)Patients with Tyndall + at baseline (n=57)-23 (40.3)45 (78.9)47 (82.4)57 (100)57 (100)Vitritis improvement, n (%)Patients with Vitritis at baseline (n=14)-5 (35.7)8 (57.1)13 (92.8)14 (100)14 (100)OCT (µm) (mean±SD)297.5±48.1297.1±45.5286.5±39.8*277.6±43.3*271.5±38.6*269.0±38.8*Choroiditis, affected eyes, n (%)3 (2.4)3 (2.4)2 (1.6)2 (1.6)1 (0.8)1 (0.8)Retinal vasculitis, affected eyes, n (%)3 (2.4)2 (1.6)1 (0.8)0 (0)0 (0)0 (0)*p<0.01ConclusionCZP seems to be effective and safe in the control of uveitis associated to different IMIDs.References[1]Jaffe GJ, et al. N Engl J Med 2016;375:932-43. doi: 10.1056/NEJMoa1509852.[2]Nguyen QD, et al. Lancet 2016;388:1183-92. doi: 10.1016/S0140-6736(16)31339-3.[3]Martín-Varillas JL, et al. Ophthalmology 2018; 125:1444-1451 doi: 10.1016/j.ophtha.2018.02.020[4]Martín-Varillas JL, et al. J Rheumatol. 2021;48:741-750. doi: 10.3899/jrheum.200300[5]Atienza-Mateo B. Arthritis Rheumatol. 2019;71:2081-2089. doi: 10.1002/art.41026.[6]Vegas-Revenga N et al Am J Ophthalmol. 2019;200:85-94. doi: 10.1016/j.ajo.2018.12.019Disclosure of InterestsNone declared
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