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Background Currently available evidence indicates that a single switch from a bio-originator to one of its biosimilars is safe and effective and has cost benefits to the National Health Systems. However, there is some reluctance to switch patients due to lack of real-world data and differences between patients treated in the setting of real clinical practice and those of clinical trials Objectives We aimed to investigate the efficacy and safety of Etanercept-biosimilar (SB4), in a non-medical switch in patients with inflammatory arthritis (IA) Methods At Cabuenes Hospital a non-medical switch from Etanercept (ETN) to SB4 was carried out in March 2018. Inflammatory arthritis patients (rheumatoid arthritis (AR), psoriatic arthritis (APS), axial spondyloarthritis (AS), juvenile idiopathic arthritis (JIA)) were included in this single-center retrospective observational study from March 2018 to December 2018. Reasons for SB4 withdrawal were categorized as lack of effect (LOE), adverse events (AE) or others. Results A total of 117 patients were identified, 100% were switched to SB4 maintaining the same dose. Disease duration was 5 (2–8,5) years. 49 patients (41%) had basal optimized dose of ETN (dose down-titration or dose interval expansion). In most patients ETN was the first biologic. 31 patients (26%) stopped SB4 treatment during follow-up, mainly due to LOE (67%) or AE (25%), with median duration of SB4 3,5 months (1,9-5,9). Most AE that led to withdrawal were dermatological (injection-site reactions, skin rash). 11 patients switched back to ETN, 15 to others. Two patients died, both were APS (one sudden death and one aneurysmal subarachnoid hemorrhage). After switching to SB4, one stable patient with AS had recurrent acute anterior uveitis, and psoriasis worsening were noted in 2 patients with APS. 2 patients needed reinstatement of the full dose of biologic because of LOE. The clinical situation on ETN was stable in 23 of the 31 (74%) patients who stopped SB4 (no flares or changes in treatment in the last 6 months before switch). Table 1 summarizes baseline characteristics and treatment outcomes. Conclusion Biosimilar switch of SB4 was successful in over 74% of cases and was well tolerated. Most patients who stopped SB4 due to LOE had a clinical stable situation in this observational study. Some concerns regarding the safety profile and interchangeability have raised and further evidence on the efficacy of transitioning from reference ETN is needed. References [1] Kay J, Schoels MM, Dorner T, et al. Ann Rheum Dis2018;77:165-174 [2] Emery P, Vencovsky J, Sylwestrzak A, et al. Ann Rheum Dis2017;76:51–57 [3] Glintborg B, et al. Ann Rheum Dis2019Feb;78(2):192-200 Disclosure of Interests None declared

Background The experience of patients with healthcare has been associated to important outcomes. Objectives We describe the experience with healthcare of patients with rheumatic diseases from Spain self-reported through IEXPAC, a validated questionnaire, and the influence of demographic and health care-related factors. Methods The IEXPAC scale (“Instrument to Evaluate the EXperience of PAtients with Chronic diseases”, http://www.iemac.es/iexpac/) was developed and validated in Spain by health care professional and social organizations, experts in quality of healthcare and chronic patients (1). It consists of 12 items with Likert responses from “always” to “never” and yields an overall score from 0 (worst) to 10 (best experience). Three factors with sub-scores derive from the scale: Factor 1 (productive interactions, average of items 1, 2, 5 and 9, on patient-health care professionals relationship), Factor 2 (new relational model, average of items 3, 7 and 11, on the use of new technologies and contact with other patients) and Factor 3 (self-management, patients’ ability to self-care, average of items 4, 6, 8 and 10). Data were obtained through an anonymous survey to patients from 25 Spanish hospitals. Bivariate comparisons and a multivariate analysis were made to explore the association between scores and demographic and health care-related characteristics. Results 625 patients received the survey, 359 (57.4%) returned it (mean age 55 years, 67% women). The percentage of patients who responded “always” or “nearly always” to the different statements is displayed in table 1. Mean overall IEXPAC score was 5.5 (SD 2.0), sub-scores were: productive interactions: 7.5 (2.5); new relational model: 1.7 (2.1); self-care: 6.5 (2.5). Overall score was higher (better experience) in men (p= 0.022), in those needing follow-up in a different region (p= 0.004), seen by a lower number of physicians (p= 0.025), seen by the same physician each time (p Conclusion Through IEXPAC, patients with rheumatic diseases identified areas of improvement in healthcare, especially those related with access to reliable information and services, interaction with other patients and continuity of health care after hospital discharge. Better experience was associated to being seen by lower number of specialists or being followed-up by the same physician each time, and also with treatment with SC/IV drugs, maybe in relation to the more personalized care these patients receive. Acknowledgement Funded by MSD of Spain and endorsed by 4 patients associations: ACCU, CONARTRITIS, SEISIDA, FEDE. We thank the participant patients for providing this valuable information by completing the survey. Disclosure of Interests Javier de Toro-Santos: None declared, Maria L. Garcia Vivar: None declared, Lucia Pantoja: None declared, Cristina Lerin Lozano: None declared, Silvia Garcia-Diaz: None declared, Yvonne Mestre Employee of: MSD, Sabela Fernandez Employee of: MSD, Luis Cea-Calvo Employee of: MSD

Background Recently, based on the GiACTA trial results, weekly subcutaneous Tocilizumab (TCZ) has been approved for the treatment of Giant Cell Arteritis (GCA). It has showed to be effective and safety. Objectives Our aim was to compare the efficacy of TCZ according the route of administration. Methods Multicenter study of 134 GCA patients in treatment with TCZ. It was performed a comparative study between 2 groups according the route of administration of TCZ, intravenous (IV) or subcutaneous (SC). Results We study 134 patients divided in 2 groups: a) IV TCZ, 104 cases and, b) SC TCZ, 30 cases, with a mean age 73.4±8.2 years vs 71.9±10.6 years, respectively (p=0.501). Disease duration, clinical manifestations and acute phase reactants at TCZ onset were similar in both groups with non-statistical difference. 91.7% patients who received SC TCZ achieved prolonged remission after 12 months of treatment (p=0.043). And the glucocorticoid sparing effect of TCZ was greater in the same group, reaching a statistical difference at 3 and 24 months (p=0.017 and p=0.021). Patients under IV TCZ treatment suffered more adverse event during follow up (p=0.043). TABLE 1 and 2 summarizes the comparative study. Conclusion Patients in treatment with SC TCZ, reached prolonged remission after 12 months of treatment and were able to discontinue prednisone dose after 24 months of follow up. The incidence of adverse events was more frequent in the IV TCZ group, without difference in relation to infections. References [1] Stone JH, Tuckwell K, Dimonaco S, Klearman M, Aringer M, Blockmans D, et al. Trial of Tocilizumab in Giant-Cell Arteritis. N Engl J Med. 2017; 377:317-28. [2] Calderon-Goercke M. Tocilizumab in giant cell arteritis. Observational, open-label multicenter study of 134 patients in clinical practice. Semin Arthritis Rheum. 2019 Jan 5. pii: S0049-0172(18)30571-7. doi: 10.1016/j.semarthrit.2019.01.003. [Epub ahead of print] Disclosure of Interests Monica Calderon-Goercke: None declared, J. Loricera: None declared, D. Prieto-Pena: None declared, Vicente Aldasoro: None declared, Santos Castaneda Consultant for: Amgen, BMS, Pfizer, Lilly, MSD, Roche, Sanofi, UCB, Ignacio Villa-Blanco: None declared, Alicia Humbria: None declared, Clara Moriano: None declared, Susana Romero-Yuste: None declared, J. Narvaez Consultant for: Bristol-Myers Squibb, Catalina Gomez-Arango: None declared, Eva Perez-Pampin: None declared, Rafael Melero: None declared, Elena Becerra-Fernandez: None declared, Marcelino Revenga: None declared, Noelia Alvarez-Rivas: None declared, Carles Galisteo: None declared, Francisca Sivera: None declared, Alejandro Olive: None declared, Maria Alvarez del Buergo: None declared, Luisa Marena Rojas: None declared, Carlos Fernandez-Lopez: None declared, Francisco Navarro: None declared, Enrique Raya: None declared, Eva Galindez: None declared, Beatriz Arca: None declared, Roser Solans-Laque: None declared, Arantxa Conesa: None declared, Cristina Hidalgo: None declared, Carlos Vazquez: None declared, Jose Andres Roman-Ivorra: None declared, Pau Lluch: None declared, Sara Manrique Arija Speakers bureau: ABBvie, MSD, Janssen, Lillly, Roche, Pfyzer, Novartis., Paloma Vela-Casasempere Grant/research support from: UCB, Abbvie, Pfizer, Roche, Bristol-Myer-Squibb (another research, not BIOBADASER related), Consultant for: UCB, Lilly, Pfizer, Roche, Bristol-Myer-Squibb, Speakers bureau: Roche, UCB, MSD, Pfizer, GSK, BMS, Lilly, Eugenio de Miguel: None declared, Carmen Torres-Martin: None declared, Juan Carlos Nieto: None declared, Carmen Ordas-Calvo: None declared, Eva Salgado-Perez: None declared, Cristina Luna-Gomez: None declared, Francisco J. Toyos Saenz de Miera: None declared, Nagore Fernandez-Llanio: None declared, Antonio Garcia: None declared, Carmen Larena: None declared, Natalia Palmou-Fontana: None declared, Vanesa Calvo-Rio: None declared, Carmen Gonzalez-Vela: None declared, Alfonso Corrales: None declared, Maria Varela-Garcia: None declared, Elena Aurrecoechea: None declared, Raquel Dos-Santos: None declared, Angel Garcia-Manzanares: None declared, Norberto Ortego: None declared, Sabela Fernandez: None declared, Francisco Ortiz-Sanjuan: None declared, Montserrat Corteguera: None declared, J. Luis Hernandez: None declared, Miguel A Gonzalez-Gay Grant/research support from: Prof. MA Gonzalez-Gay received grants/research supports from Abbvie, MSD, Jansen and Roche., Speakers bureau: Consultation fees/participation in company sponsored speaker’s bureau from Pfizer, Lilly, Sobi, Celgene, Novartis, Roche and Sanofi., Ricardo Blanco Grant/research support from: Abbvie, MSD, and Roche, Consultant for: Abbvie, Pfizer, Roche, Bristol-Myers, Janssen, Speakers bureau: Abbvie, Pfizer, Roche, Bristol-Myers, Janssen