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To describe the clinical and therapeutic management of rheumatoid arthritis (RA) patients with biological disease-modifying antirheumatic drugs (bDMARDs), alone or in combination with conventional synthetic DMARDs (csDMARDs), as well as analysing changes over time in bDMARD use. An observational, retrospective, multicentre study was conducted in the rheumatology departments of 10 public Spanish hospitals. Patients with RA treated with bDMARDs at baseline who had medical records available in the data collection period 2013-2016 were included. All visits to rheumatology departments recording any type of bDMARD modification (dose, etc.) were collected. Clinical characteristics, concomitant treatment, resource use, work productivity and quality of life (QoL) were recorded. 128 patients were included: 81 received first-line bDMARD treatment, 28 second-line bDMARD treatment and 19 received third or later lines. Mean study follow-up was 4.1 years. Assessment of DAS28 was available in 54.6% of visits. At baseline, 48.7% of patients had moderate-high disease activity. At final observation, 69.5% of patients continued with the first bDMARD. Tumour necrosis factor blockers were administered to 85.2% of patients in first line, 45.7% in second line and 18.1% in third or later lines. At final observation, 80.2% of patients still felt pain/discomfort. As expected, those with higher disease activity had higher loss of work productivity and lower QoL, as assessed by DAS28, than patients with lower disease activity. Drugs represented 82.6% of the total cost. In this Spanish cohort of 128 patients, most patients remained on the first prescribed bDMARD, despite remaining signs and symptoms.

Resumen Introduccion El Sistema Nacional de Salud ofrece en Espana la atencion reumatologica. Mas de una cuarta parte del gasto sanitario se realiza en medicina privada. En la actualidad no existen datos sobre el numero de reumatologos con actividad privada en Espana. Objetivos Evaluar los reumatologos con actividad privada en Espana describiendo su perfil y localizacion. Material y metodos Desde la Comision de Practica Privada de la SER, se elaboro una encuesta que se envio a todos los socios reumatologos en activo. La recogida de datos finalizo en diciembre del 2014. Se analizaron los datos mediante estadistica descriptiva y se realizo una comparacion de los resultados. Resultados Se obtuvieron 759 respuestas de un total de 980 encuestas enviadas (77,45%). El 38% de los reumatologos espanoles tienen actividad privada; el 13% en exclusiva (privada) y el 25% compartida con su actividad publica (mixta). El perfil del reumatologo que trabaja en la medicina privada es: genero masculino, 49 anos de edad con 19 anos de experiencia, su jornada laboral es de 42 h semanales. Existe un claro predominio de la practica privada en la CC. AA. de Cataluna (28% del total), seguida por las CC. AA. de Madrid con un 18%, Andalucia con un 12% y Valencia con un 8%. Conclusiones El 38% de los reumatologos espanoles trabajan en la medicina privada. El perfil profesional en reumatologia privada es distinto del que trabaja exclusivamente en la sanidad publica. Existe reumatologia privada en todas las CC. AA, aunque la mayoria de reumatologos privados se localizan en las CC. AA. de Cataluna, Madrid, Valenciana y Andalucia, representando mas del 50% del total.

Introduction Rheumatologic care is offered by the National Health System in Spain. However, more than a quarter of health spending is carried out in private medicine. Currently, there are no data about the number of rheumatologists with private activity in Spain. Objectives To evaluate the number of rheumatologists with private activity in Spain and to describe the profile and location of these professionals. Material and methods A survey was developed and sent from the SER Commission on Private Practice to all SER active members. Data collection ends in December 2014. A descriptive statistical analysis and comparison of results was done. Results 759 answers from a total of 980 surveys sent (77.45%) were obtained; 38% of Spanish rheumatologists have private activity; 13% exclusively private practice and 25% private practice shared with his or her public activity. The private practice rheumatologist profile is: male, 49 years old with 19 years of experience after finishing the specialty and with a working day of 42 h per week. There is a clear predominance of private practice in the Autonomous Community of Catalonia with 28% of the total, followed by Madrid 18%, Andalusia 12% and Valencia 8%. Conclusions 38% of Spanish rheumatologists are working in private practice. The profile of professionals working in private practice is different from that of those who work exclusively in public health. Private rheumatology is located in all regions, although most private rheumatologists are located in the regions of Catalonia, Madrid, Valencia and Andalusia, representing more than 50% of the total.

ObjectiveEvaluate open-label sarilumab monotherapy in patients with rheumatoid arthritis switching from adalimumab monotherapy in MONARCH (NCT02332590); assess long-term safety and efficacy in patients continuing sarilumab during open-label extension (OLE).MethodsDuring the 48-week OLE, patients received sarilumab 200 mg subcutaneously once every 2 weeks. Safety (March 2017 cut-off) and efficacy, including patient-reported outcomes, were evaluated.ResultsIn the double-blind phase, patients receiving sarilumab or adalimumab monotherapy showed meaningful improvements in disease activity; sarilumab was superior to adalimumab for improving signs, symptoms and physical function. Overall, 320/369 patients completing the 24-week double-blind phase entered OLE (155 switched from adalimumab; 165 continued sarilumab). Sarilumab safety profile was consistent with previous reports. Treatment-emergent adverse events were similar between groups; no unexpected safety signals emerged in the first 10 weeks postswitch. Among switch patients, improvement in disease activity was evident at OLE week 12: 47.1%/34.8% had changes ≥1.2 in Disease Activity Score (28 joints) (DAS28)-erythrocyte sedimentation rate/DAS28-C-reactive protein. In switch patients achieving low disease activity (LDA: Clinical Disease Activity Index (CDAI) ≤10; Simplified Disease Activity Index (SDAI) ≤11) by OLE week 24, 70.7%/69.5% sustained CDAI/SDAI LDA at both OLE weeks 36 and 48. Proportions of switch patients achieving CDAI ≤2.8 and SDAI ≤3.3 by OLE week 24 increased through OLE week 48. Improvements postswitch approached continuation-group values, including scores ≥normative values.ConclusionsDuring this OLE, there were no unexpected safety issues in patients switching from adalimumab to sarilumab monotherapy, and disease activity improved in many patients. Patients continuing sarilumab reported safety consistent with prolonged use and had sustained benefit.

Background: The EXTEND open-label extension study (NCT01146652) is collecting data on long-term treatment of RA with sarilumab as monotherapy and in combination with conventional synthetic (cs)DMARDs, predominantly methotrexate. Objectives: Post hoc analysis to compare outcomes between patients (pts) who received sarilumab monotherapy, received sarilumab +csDMARDs, or who discontinued csDMARDs during sarilumab treatment. Methods: Pts enrolled in four trials of sarilumab SC 150 or 200 mg q2w +csDMARDs (MOBILITY, NCT01061736; TARGET, NCT01709578; ASCERTAIN, NCT01768572; and NCT01217814) and an open-label sarilumab monotherapy study (ONE, NCT02121210) were eligible to receive open-label sarilumab SC 200 mg q2w in EXTEND, +csDMARDs if given in the parent trial. In EXTEND, csDMARDs could be stopped at investigator discretion (reasons for csDMARD withdrawal were not recorded). Post hoc analyses were conducted on three pt groups: Group 1 permanently discontinued csDMARDs at any time during Wks 0–96 of EXTEND and subsequently received sarilumab monotherapy; Group 2 continued csDMARDs; and Group 3 enrolled from the monotherapy study and never received csDMARDs. A subgroup of Group 1, comprising pts who received csDMARDs during Wks 0–12 and discontinued csDMARDs during Wks >12–96, was used for sensitivity analysis. Results: There were 42 pts in Group 1, 1851 in Group 2, and 111 in Group 3 with minor differences between groups in demographics and disease characteristics at entry into EXTEND. The proportion of pts remaining on study at 96 wks was 69%, 80% and 83% in Groups 1, 2 and 3, respectively. Similar substantial and durable response rates (CDAI ≤2.8, CDAI ≤10, DAS28-CRP Conclusion: Over the 120-wk study period, pts initially on sarilumab +csDMARDs who subsequently discontinued csDMARDs maintained similar clinical responses as pts who continued sarilumab +csDMARDs or received sarilumab monotherapy throughout. The AE profile was as expected, with no new safety signals. Acknowledgement: Study funding and medical writing support (Matt Lewis, Adelphi) provided by Sanofi and Regeneron Pharmaceuticals, Inc. Disclosure of Interests: Jeffrey R. Curtis Grant/research support from: Abbvie, Amgen, BMS, Corrona, Janssen, Lilly, Myriad, Pfizer, Roche/Genentech, UCB, Consultant for: Abbvie, Amgen, BMS, Corrona, Janssen, Lilly, Myriad, Pfizer, Roche/Genentech, UCB, Yong Lin Shareholder of: Sanofi, Employee of: Sanofi, Karthinathan Thangavelu Shareholder of: Sanofi, Employee of: Sanofi, Marina Stanislav Consultant for: R-Pharm, Gregory St. John Shareholder of: Regeneron Pharmaceuticals, Inc, Employee of: Regeneron Pharmaceuticals, Inc, Antonio Gomez-Centeno Grant/research support from: Boehringer Ingelheim, Celltrion, Galapagos-Gilead, Lilly, Novartis, Pfizer, Roche, Sanofi, UCB, YL Biologics, Consultant for: Abbvie, Biogen, BMS, Celgene, Gebro, Hospira, Lilly, MSD, Pfizer, Roche, Rubio, Sandoz, Sanofi, Speakers bureau: Abbvie, BMS, Gebro, Janssen, Lilly, Menarini, MSD, Pfizer, Roche, Rubio, UCB, Sanofi, Carlo Selmi Grant/research support from: AbbVie, Janssen, MSD, Novartis, Pfizer, Consultant for: AbbVie, Alfa-Sigma, Biogen, Bristol-Myrs Squibb, Celgene, Eli-Lilly, Janssen, Merck Sharp and Dohme, Novartis, Pfizer, Roche, Sanofi-Genzyme, UCB, Speakers bureau: AbbVie, Alfa-Sigma, Biogen, Bristol-Myrs Squibb, Celgene, Eli-Lilly, Janssen, Merck Sharp and Dohme, Novartis, Pfizer, Roche, Sanofi-Genzyme, UCB, Thomas Huizinga Consultant for: Merck, UCB, Bristol Myers Squibb, Biotest AG, Pfizer, GSK, Novartis, Roche, Sanofi-Aventis, Abbott, Crescendo Bioscience Inc., Nycomed, Boeringher, Takeda, Zydus, Epirus, Eli Lilly, Jose Antonio Maldonado-Cocco Consultant for: Pfizer, Merck Sharp Dohme, Sanofi – Aventis, Novartis, Bristol Myers Squibb, Roche, Boehringer Ingelheim, Schering – Plough, Abbott, UCB, Eli Lilly, Gilead, Speakers bureau: Pfizer, Merck Sharp Dohme, Sanofi – Aventis, Novartis, Bristol Myers Squibb, Roche, Boehringer Ingelheim, Schering – Plough, Abbott, UCB, Eli Lilly., Marwan Bukhari Speakers bureau: Bristol-Myers Squib, UCB celltech, Roche/Chugai, Pfizer, Abbvie, Merck, Mennarini, Sanofi-aventis, Eli-Lilly, Janssen and Novartis., Frank Buttgereit: None declared

Background:The Janus kinase-1 preferential inhibitor filgotinib (FIL) improved signs and symptoms of rheumatoid arthritis (RA) in the FIL clinical program.1–3Objectives:To assess FIL safety across regions.Methods:This was an analysis of patients (pts) meeting 2010 ACR/EULAR RA criteria in pooled phase (P)2 DARWIN 1–2 (D1–2), P3 FINCH 1–3 (F1–3), and long-term extension studies (DARWIN 3, FINCH 4). Data were analyzed by region: North America, South and Central America, Western Europe, Eastern Europe, Asia, South East (SE) Asia, and Other. Week (W)12 placebo (PBO)-controlled analysis included data from pts receiving once-daily FIL 100 mg (FIL100), FIL 200 mg (FIL200), or PBO for ≤12W (D1–2, F1–2); long-term as-treated data included pts from all 7 studies receiving FIL100 or FIL200; data after rerandomization were included and contributed to treatment received. Data presented as exposure-adjusted incidence rates (EAIRs)/100 patient-years of exposure (PYE) of treatment-emergent (TE) adverse events (TEAEs).Results:Table 1 shows EAIRs of TEAEs in PBO-controlled analysis. EAIRs/100 PYE of all TEAEs in Western Europe, Asia, and Other were higher than in remaining regions and for PBO vs FIL arms; EAIRs for FIL200/FIL100 in North America and SE Asia were higher vs PBO. EAIRs/100 PYE of TE serious AEs were higher in SE Asia for FIL100 and for FIL200/FIL100 in Other, with high PBO EAIRs in Western Europe. EAIRs/100 PYE of TEAEs leading to study discontinuation were higher in FIL arms vs PBO in Western Europe and Other (FIL200); in Asia and SE Asia, EAIRs were higher for PBO vs FIL200/FIL100.Table 1.EAIR of TEAEs (placebo-controlled)North AmericaN = 481South and Central AmericaN = 350Western EuropeN = 141Eastern EuropeN = 933AsiaN = 236South East AsiaN= 135OtherN = 70TEAEFIL200a216.9 (162.5, 289.5)205.6 (155.1, 272.6)285.0 (188.6, 430.8)150.3 (119.3, 189.4)248.9 (180.6, 343.1)165.1 (104.0, 262.1)298.4 (150.3, 592.5)FIL100b182.2 (136.8, 242.7)159.2 (117.3, 216.1)285.7 (183.7, 444.3)146.4 (115.9, 185.0)246.9 (180.3, 338.1)153.7 (94.2, 251.0)263.5 (113.9, 609.2)PBOC174.5 (130.3, 233.7)162.1 (118.8, 221.2)314.9 (200.7, 493.9)148.4 (117.6, 187.4)259.0 (188.0, 356.8)81.6 (40.8, 163.3)306.0 (142.8, 655.7)TE serious AEFIL200a14.3 (6.0, 34.4)11.4 (3.7, 35.5)8.3 (1.2, 59.0)12.2 (5.2, 28.7)5.5 (0.8, 38.9)0.0 (0.0, ∞)49.6 (10.2, 144.9)FIL100b10.6 (4.0, 28.3)7.2 (1.8, 28.7)19.9 (5.0, 79.7)15.1 (6.8, 33.7)16.2 (5.2, 50.2)28.8 (9.3, 89.4)20.5 (0.5, 114.0)PBOC16.1 (7.2, 35.9)7.5 (1.9, 30.0)29.6 (9.5, 91.7)4.6 (1.3, 15.8)11.4 (2.8, 45.5)10.2 (1.4, 72.4)0.0 (0.0, 69.2)TEAE leading to discontinuationFIL200a8.6 (2.8, 26.6)3.8 (0.1, 21.2)16.6 (4.2, 66.5)12.9 (5.5, 30.5)0.0 (0.0, 20.2)9.2 (1.3, 65.1)16.5 (0.4, 92.1)FIL100b10.6 (4.0, 28.3)7.2 (0.9, 26.0)19.9 (5.0, 79.7)1.9 (0.2, 13.8)5.4 (0.1, 30.1)9.6 (1.4, 68.2)0.0 (0.0, 75.5)PBOC5.4 (1.3, 21.5)0.0 (0.0, 13.8)9.9 (1.4, 70.0)12.9 (5.4, 30.7)17.1 (3.5, 49.9)20.4 (5.1, 81.6)0.0 (0.0, 69.2)Data presented as EAIR (95% CI)/100 patient-yearsaN = 777, 179.8 PYE bN = 788, 181.6 PYE cN = 781, 178.4 PYEA subject may contribute to more than one treatment group if they received more than one treatment of interest.EAIR and corresponding 95% CI were estimated using Poisson regression model by treatment, including study and treatment with an offset of natural log of exposure time, except when 0 events occurred; Poisson model was not adjusted by study.AE, adverse event; CI, confidence interval; EAIR, exposure-adjusted incidence rate; FIL, filgotinib; PBO, placebo; PYE, patient-years of exposure; TE, treatment-emergentFigure shows serious infections (SI), venous thromboembolism (VTE) and herpes zoster (HZ) EAIRs.EAIRs for SI were highest in Other for FIL200 and SE Asia for FIL100. While VTE EAIRs were low, pts in 5/7 regions had VTE. HZ EAIRs were highest in Asia.Conclusion:Although EAIR of TEAEs varied between regions, no consistent trend was reflected in any particular region.References:[1]Genovese et al. JAMA. 2019;322:315–25.[2]Westhovens et al. Ann Rheum Dis. 2021; online first.[3]Combe et al. Ann Rheum Dis. 2021; online first.Disclosure of Interests:Bernard Combe Speakers bureau: BMS; Eli Lilly & Co.; Gilead Sciences, Inc.; MSD; Pfizer; Roche-Chugai; and UCB, Consultant of: AbbVie; Eli Lilly & Co.; Gilead Sciences, Inc.; Janssen; Pfizer; Roche-Chugai; and Sanofi, Grant/research support from: Novartis, Pfizer, and Roche-Chugai, Tsukasa Matsubara Speakers bureau: Pfizer Japan, Nichi-Iko, Astellas, Meiji Seika, Bristol-Myers Squibb, AbbVie GK, Janssen, Chugai, Eisai, AYUMI, Alena Pechonkina Shareholder of: Gilead Sciences, Inc., Employee of: Gilead Sciences, Inc., YingMeei Tan Shareholder of: Gilead Sciences, Inc., Employee of: Gilead Sciences, Inc., Zhaoyu Yin Shareholder of: Gilead Sciences, Inc., Employee of: Gilead Sciences, Inc., Jaehyung Hong Shareholder of: Gilead Sciences, Inc., Employee of: Gilead Sciences, Inc., Robin Besuyen Shareholder of: Galapagos, BV, Employee of: Galapagos, BV, Antonio Gomez-Centeno Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly & Co., Gebro, Janssen, Menarini, Merck Sharp & Dohme, Pfizer, Roche, Rubio, Sanofi, and UC, Consultant of: AbbVie, Biogen, Bristol-Myers Squibb, Celgene, Eli Lilly & Co., Gebro, Gilead Sciences, Inc., Hospira, Merck Sharp & Dohme, Pfizer, Roche, Rubio, Sandoz, Sanofi, Grant/research support from: Boehringer Ingelheim, Celltrion, Eli Lilly & Co., Galapagos NV, Gilead Sciences, Inc., Novartis, Pfizer, Roche, Sanofi, UCB, YL Biologics, Maya H Buch Speakers bureau: AbbVie; Eli Lilly and Company; Gilead Sciences, Inc.; Merck-Serono; Pfizer; Roche; Sandoz; Sanofi; and UCB, Consultant of: AbbVie; Eli Lilly and Company; Gilead Sciences, Inc.; Merck-Serono; Pfizer; Roche; Sandoz; Sanofi; and UCB, Grant/research support from: AbbVie; Eli Lilly and Company; Gilead Sciences, Inc.; Merck-Serono; Pfizer; Roche; Sandoz; Sanofi; and UCB

Background:The oral, potent, selective JAK1 inhibitor filgotinib (FIL) showed favorable efficacy at week (W)12 and W24 of treatment for rheumatoid arthritis (RA) compared with methotrexate (MTX) monotherapy (mono) in FINCH 3 (NCT02886728) and with placebo (PBO) or adalimumab (ADA) in FINCH 1 (NCT02889796).Objectives:50% clinical improvement from baseline at W12 is a key checkpoint for RA treatment.1These post hoc analyses evaluated FIL treatment effect on improvement in ACR components at W12 and remission at W24 in FINCH 3 and FINCH 1.Methods:FINCH 3 and FINCH 1 were global, phase 3, double-blind studies in patients (pts) with active RA. In FINCH 3, MTX-naïve pts were randomised 2:1:1:2 to once-daily (QD) oral FIL 200 mg + weekly MTX, FIL 100 mg + MTX, FIL 200 mg mono + PBO, or PBO + MTX mono up to W52. In FINCH 1, pts with inadequate response to MTX (MTX-IR) on a background of stable MTX were randomised (3:3:2:3) to oral FIL 200 or 100 mg QD, subcutaneous ADA 40 mg Q2W, or PBO up to W52. Post hoc analyses evaluated proportions of pts with 50% improvement from baseline in each ACR component and in all 7 ACR components (ACR50c) at W12, and proportions of pts with ACR50c at W12 achieving clinical remission at W24. Comparisons between treatments were not adjusted for multiplicity; subgroup comparisons are descriptive.Results:Analyses included 1249 pts in FINCH 3 and 1755 pts in FINCH 1. Greater proportions of pts receiving FIL 200 mg + MTX, FIL 100 mg + MTX, or FIL mono (FINCH 3) vs MTX mono (FINCH 3) or PBO + MTX (FINCH 1)—and numerically higher proportions of pts receiving FIL 200 mg + MTX vs FIL 100 mg + MTX (both studies) or ADA + MTX (FINCH 1)—achieved ACR50c and individual components at W12 (Table). Proportions of pts achieving CDAI ≤2.8 (Figure 1) or Boolean remission (Figure 2) at W24 were higher for pts with vs without ACR50c at W12 (Figures 1–2).Table.Proportions of patients with 50% improvement in each ACR component and ACR50c at week 12ACR componentSJC66TJC68PainPGASGAHAQ-DIhsCRPACR50cFINCH 3FIL 200 mg + MTX82.2***76.9***59.2***72.8***56.5***54.9***59.1***26.2***FIL 100 mg + MTX81.2***74.4***48.5*68.1*46.9**49.5***58.5***19.3***FIL 200 mg mono82.9***75.7***47.6*66.2*47.1**47.3**59.5***22.9***MTX mono67.159.639.258.435.635.633.76.0FINCH 1FIL 200 mg + MTX83.2***,+77.9***,+50.1***,+67.4***48.2***42.1***,+67.2***,+++18.5***FIL 100 mg + MTX77.9***72.3***45.1***62.9***43.2***35.2***55.0***12.5***ADA + MTXa76.970.541.561.542.034.455.713.8PBO + MTX66.759.228.050.928.023.125.92.5aNot formally compared vs PBO + MTX.*, p **, p ***, p +, p +++, p ACR50c, 50% improvement from baseline in all ACR components; ADA, adalimumab; FIL, filgotinib; MTX, methotrexate; mono, monotherapy; PBO, placebo.Conclusion:In MTX-naïve and MTX-IR pts with RA, FIL treatment was more effective vs MTX (FINCH 3) or PBO (FINCH 1) for achieving ACR50c at W12—a potential predictor of remission at W24. Proportions of pts achieving ACR50c at W12 were numerically higher for pts receiving FIL 200 mg + MTX vs FIL 100 mg + MTX (both studies) or ADA + MTX (FINCH 1).References:[1]Smolen JS, et al.Ann Rheum Dis. 2017;76:960–77.Disclosure of Interests:Gerd Rüdiger Burmester Consultant of: AbbVie Inc, Eli Lilly, Gilead, Janssen, Merck, Roche, Pfizer, and UCB Pharma, Speakers bureau: AbbVie Inc, Eli Lilly, Gilead, Janssen, Merck, Roche, Pfizer, and UCB Pharma, Daniel Aletaha Grant/research support from: AbbVie, Novartis, Roche, Consultant of: AbbVie, Amgen, Celgene, Lilly, Medac, Merck, Novartis, Pfizer, Roche, Sandoz, Sanofi Genzyme, Speakers bureau: AbbVie, Celgene, Lilly, Merck, Novartis, Pfizer, Sanofi Genzyme, UCB, Janet Pope Grant/research support from: AbbVie, Bristol-Myers Squibb, Eli Lilly & Company, Merck, Roche, Seattle Genetics, UCB, Consultant of: AbbVie, Actelion, Amgen, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Eicos Sciences, Eli Lilly & Company, Emerald, Gilead Sciences, Inc., Janssen, Merck, Novartis, Pfizer, Roche, Sandoz, Sanofi, UCB, Speakers bureau: UCB, Yoshiya Tanaka Grant/research support from: Asahi-kasei, Astellas, Mitsubishi-Tanabe, Chugai, Takeda, Sanofi, Bristol-Myers, UCB, Daiichi-Sankyo, Eisai, Pfizer, and Ono, Consultant of: Abbvie, Astellas, Bristol-Myers Squibb, Eli Lilly, Pfizer, Speakers bureau: Daiichi-Sankyo, Astellas, Chugai, Eli Lilly, Pfizer, AbbVie, YL Biologics, Bristol-Myers, Takeda, Mitsubishi-Tanabe, Novartis, Eisai, Janssen, Sanofi, UCB, and Teijin, Patrick Durez Speakers bureau: AbbVie, Bristol-Myers Squibb, Celltrion, Eli Lilly, Pfizer, Sanofi, Antonio Gomez-Centeno: None declared, Alena Pechonkina Shareholder of: Gilead Sciences, Inc., Employee of: Gilead Sciences, Inc., Beatrix Bartok Shareholder of: Gilead Sciences Inc., Employee of: Gilead Sciences Inc., Franziska Matzkies Shareholder of: Gilead Sciences, Inc., Employee of: Gilead Sciences, Inc., Lei Ye Shareholder of: Gilead Sciences Inc., Employee of: Gilead Sciences Inc., Zhaoyu Yin Shareholder of: Gilead Sciences, Inc., Employee of: Gilead Sciences, Inc., Robin Besuyen Shareholder of: Galapagos, Employee of: Galapagos, William Rigby Grant/research support from: Bristol-Myers Squibb, Consultant of: AbbVie, Bristol-Myers Squibb, Genentech, Pfizer, Bernard Combe Grant/research support from: Novartis, Pfizer, Roche-Chugai, Consultant of: AbbVie; Gilead Sciences, Inc.; Janssen; Eli Lilly and Company; Pfizer; Roche-Chugai; Sanofi, Speakers bureau: Bristol-Myers Squibb; Gilead Sciences, Inc.; Eli Lilly and Company; Merck Sharp & Dohme; Pfizer; Roche-Chugai; UCB

Background Reducing the dose of biological therapy (BT) when patients with immune-mediated arthritis achieve a sustained therapeutic goal may help to decrease costs for national health services and reduce the risk of serious infection. However, there is little information about whether such a decision can be applied universally. Therefore, the objective of this study was to develop appropriateness criteria for reducing the dose of BT in patients with rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), and peripheral spondyloarthritis (pSpA). Methods The RAND/UCLA appropriateness method was coordinated by experts in the methodology. Five rheumatologists with clinical research experience in RA and/or SpA selected and precisely defined the variables considered relevant when deciding to reduce the dose of BT in the 3 diseases, in order to define patient profiles. Ten rheumatologists with experience in prescribing BT anonymously rated each profile on a scale of 1 (completely inappropriate) to 9 (completely appropriate) after revising a summary of the evidence obtained from 4 systematic literature reviews carried out specifically for this project. Findings A total of 2,304 different profiles were obtained for RA, 768 for axSpA, and 3,072 for pSpA. Only 327 (14.2%) patient profiles in RA, 80 (10.4%) in axSpA, and 154 (5%) in pSpA were considered appropriate for reducing the dose of BT. By contrast, 749 (32.5%) patient profiles in RA, 270 (35.3%) in axSpA, and 1,243 (40.5%) in pSpA were considered inappropriate. The remaining profiles were considered uncertain. Interpretation Appropriateness criteria for reducing the dose of BT were developed in 3 inflammatory conditions. These criteria can help clinicians treating these disorders to optimize the BT dose. However, further research is needed, since more than 50% of the profiles were considered uncertain and the real prevalence of each profile in daily clinical practice remains unknown.

Objectives: To describe the prevalence of comorbidities in patients with RA in Spain and discuss their management and implications using data from the Spanish cohort of the multinational study on COMOrbidities in Rheumatoid Arthritis (COMORA). Methods: This is a national sub-analysis of the COMORA study. We studied the demographics and disease characteristics of 200 adults patients diagnosed with RA (1987 ACR), and routine practices for screening and preventing the following selected comorbidities: cardiovascular, infections, cancer, gastrointestinal, pulmonary, osteoporosis and depression. Results: Patients had a mean age of 58 years and a mean RA duration of 10 years. Mean DAS28 score was 3.3 and approximately 25% of patients were in remission (DAS28 20% (51%), hypercholesterolemia (46%) or hypertension (41%) and smoking (25%) were the most common CV risk factors. For prostate, colon and skin cancers, only 9%, 10% and 18% of patients, respectively, were optimally monitored. Infections were also inadequately managed, with 7% and 17% of patients vaccinated against influenza and pneumococcal, respectively, as was osteoporosis, with 47% of patients supplemented with vitamin D and 56% with a bone densitometry performed. Conclusions: In Spain, the prevalence of comorbidities and CV risk factors in RA patients with established and advanced disease is relatively high, and their management in clinical daily practice remains suboptimal. Objetivos: Describir la prevalencia de comorbilidades en pacientes con AR en España y discutir sobre su manejo en la clínica diaria utilizando los datos de la cohorte española del estudio internacional COMORA. Métodos: Subanálisis nacional del estudio COMORA en el que se analizaron las características demográficas y clínicas de 200 pacientes con AR (1987 ACR) y las prácticas rutinarias para el cribado y la prevención de eventos cardiovasculares (CV), gastrointestinales y pulmonares, infecciones, cáncer, osteoporosis y depresión. Resultados: Los pacientes tenían una edad media de 58 años, una duración media de la enfermedad de 10 años, un DAS28 de 3,3 y el 25% estaba en remisión (DAS28 20% (51%), tener hipercolesterolemia (46%), hipertensión (41%) y fumar (25%) fueron los factores de riesgo CV más comunes. En relación con el cáncer de próstata, colon y piel, solo el 9, 10 y el 18% de los pacientes, respectivamente, estaban óptimamente controlados. Las infecciones tampoco se manejaban de forma óptima, con solo el 7 y el 17% de los pacientes vacunados contra la influenza y neumococo, respectivamente, al igual que la osteoporosis, con el 47% suplementados con la vitamina D y el 56% con una densitometría realizada. Conclusiones: En España, la prevalencia de comorbilidades y factores de riesgo CV en pacientes con AR establecida y avanzada es relativamente alta, y su manejo en la clínica diaria continúa siendo subóptimo. Sin financiación No data JCR 2019 0.256 SJR (2019) Q4, 49/64 Rheumatology No data IDR 2019 UEM

Resumen Antecedentes En los ultimos anos, las Unidades de Hospitalizacion de Dia (UHdD) en Reumatologia han experimentado un amplio desarrollo. Sin embargo, existe escasa documentacion respecto a estandares de calidad, que mayoritariamente se limita a la estructura y no incluye aspectos especificos de la especialidad. Objetivo Desarrollar estandares de calidad especificos para las UHdD en Reumatologia. Metodos Tras una revision sistematica de la literatura y de documentos relacionados, un grupo de trabajo (GT) de 8 reumatologos, bajo la supervision de un metodologo experto, elaboro una primera propuesta de estandares de calidad. Se realizo una segunda ronda para su revision y sugerencias por todo el GT. Consensuado el contenido, se realizo un informe final. Resultados Se definieron 17 estandares de estructura, 25 de proceso y 10 de resultados, con especial enfasis en aspectos especificos de una UHdD de Reumatologia. La propuesta incluye: 1) estandares imprescindibles; 2) estandares de excelencia; 3) cartera de servicios de una UHdD reumatologica, y 4) criterios de funcionamiento. Conclusiones Los estandares de calidad propuestos son la base para la elaboracion de indicadores y de otras herramientas de gestion para las UHdD reumatologicas que garanticen una practica homogenea, centrada en el paciente y basada en la evidencia y en la experiencia.

Contains fulltext : 172780.pdf (Publisher’s version ) (Open Access) Treating to target by monitoring disease activity and adjusting therapy to attain remission or low disease activity has been shown to lead to improved outcomes in chronic rheumatic diseases such as rheumatoid arthritis and spondyloarthritis. Patient-reported outcomes, used in conjunction with clinical measures, add an important perspective of disease activity as perceived by the patient. Several validated PROs are available for inflammatory arthritis, and advances in electronic patient monitoring tools are helping patients with chronic diseases to self-monitor and assess their symptoms and health. Frequent patient monitoring could potentially lead to the early identification of disease flares or adverse events, early intervention for patients who may require treatment adaptation, and possibly reduced appointment frequency for those with stable disease. A literature search was conducted to evaluate the potential role of patient self-monitoring and innovative monitoring of tools in optimising disease control in inflammatory arthritis. Experience from the treatment of congestive heart failure, diabetes and hypertension shows improved outcomes with remote electronic self-monitoring by patients. In inflammatory arthritis, electronic self-monitoring has been shown to be feasible in patients despite manual disability and to be acceptable to older patients. Patients' self-assessment of disease activity using such methods correlates well with disease activity assessed by rheumatologists. This review also describes several remote monitoring tools that are being developed and used in inflammatory arthritis, offering the potential to improve disease management and reduce pressure on specialists.

To assess the diagnostic usefulness of the systematic analysis of synovial vascular morphology in various inflammatory, early, and longstanding arthropathies, and to examine the validity of the vascular patterns in predicting the evolution of a group of patients with undifferentiated arthritis (UA).One hundred patients who underwent rheumatologic arthroscopy of a symptomatic joint (85 knees, 11 wrists, 3 elbows, 1 metacarpophalangeal joint) were evaluated. The same observer, blinded to patient diagnosis, analyzed the video recordings of the arthroscopies. Vascular morphology was classified into 3 patterns: straight, tortuous, and mixed.Eighty-one patients had inflammatory arthritis: 35 rheumatoid arthritis (RA), 16 psoriatic arthritis (PsA), 13 spondyloarthropathies (SpA), and 17 UA. Forty-nine percent of patients with RA had a straight pattern, 28% a mixed, and 23% a tortuous one. The sensitivity rate of the straight pattern for RA was 77% and the specificity rate was 70%. Seventy-six percent of RA patients with a straight pattern were rheumatoid factor positive (RF+) against 25% of RA patients with a tortuous pattern. The odds ratio for RA associated to straight compared with tortuous pattern was 57.3 (95% confidence interval, 6.6 to 499.5; P.001). Patients with PsA and SpA shared the same pattern and were analyzed as 1 group. Ninety-three percent of patients with PsA/SpA had a tortuous pattern, 4% a straight pattern, and 3% a mixed pattern. The sensitivity rate of the tortuous pattern for PsA/SpA was 61% and the specificity rate was 95%. During 2 years of follow-up, 6 of 17 patients with UA were definitely diagnosed: 4 RA (2 RF+ and straight pattern; 2 with a tortuous pattern, 1 with RF+ and HLA-B27+); 1 SpA and 1 PsA, both with a tortuous pattern. No differences in vascular patterns were observed according to disease duration. Our results indicate that vascular patterns are not modified by disease modifying antirheumatic drug (DMARD) treatment. The other 19 patients had osteoarthritis (n = 8) and calcium pyrophosphate dihydrate crystal deposition disease (n = 11) and their predominant vascular pattern was tortuous-like.Arthroscopic assessment of synovial vascular changes in chronic arthritis may be of diagnostic and pathogenetic interest, although differences between published studies suggest a need for consensus in evaluating vascular patterns. A straight pattern is strongly associated with RF + RA whereas a tortuous pattern is generally associated with PsA or SpA; these associations are independent of disease duration. The vascular pattern likely does not change qualitatively with DMARD therapy. The application of this technique to the diagnosis or prognosis of patients with UA may be a complementary tool for the treatment of these patients, but larger, prospective studies are necessary to confirm this hypothesis.

Background In recent years, the Rheumatology Day-Care Hospital Units (DHUs) have undergone extensive development. However, the quality standards are poorly documented and mainly limited to structure items rather than including broad and specific areas of this specialty. Objective To develop specific quality standards for Rheumatology DHUs. Methods After a systematic review of the literature and related documents, a working group (WG) involving 8 DHU-experienced rheumatologists developed an initial proposal of the quality standards, under the supervision of an expert methodologist. A second round was held by the WG group to review the initial proposal and to consider further suggestions. Once the content was agreed upon by consensus, a final report was prepared. Results Seventeen structure standards, 25 process standards and 10 results standards were defined, with special emphasis on specific aspects of the Rheumatology DHU. The proposal includes: (1) essential standards to (2) excellent standards, (3) a Rheumatology DHU services portfolio and (4) performance criteria. Conclusions The proposed quality standards are the basis for developing the indicators and other management tools for Rheumatology DHU, thereby ensuring a patient-oriented practice based on both the evidence and the experience.

Objective. To analyze the effects of cigarette smoking on disease activity and radiographic damage in patients with early rheumatoid arthritis (RA). Methods. Study subjects were 156 patients with early RA (< 2 yrs). Disease activity, therapeutic response, and radiographic progression were compared in smokers and nonsmokers at 24 months. Results. At baseline, ever-smokers had earlier disease onset and a closer association with the shared epitope (SE), but not more seropositive disease. No significant differences were observed in disease activity and European League Against Rheumatism therapeutic responses between smokers and nonsmokers. Multivariate analysis showed that baseline Larsen score, the HLA-DRB*04 genotype, being female, and current smoking were associated with radiographic progression. Conclusion. In patients with early RA, smoking was associated with earlier disease onset and the SE. Smoking was an independent factor of radiographic progression., Supported by a grant (Premi Fi de Residencia 2009; Dr. Ruiz-Esquide) from the Hospital Clinic of Barcelona.

The objective of the study was to analyze the prognostic factors of radiographic progression in a series of patients with early rheumatoid arthritis (RA) after 2 years of therapy with a structured algorithm using disease-modifying antirheumatic drugs (DMARDs) and very low doses of oral glucocorticoids. One hundred and five patients (81% female) with early RA (disease duration