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Objective To evaluate and compare benefits and harms of three biological treatments with different modes of action versus active conventional treatment in patients with early rheumatoid arthritis. Design Investigator initiated, randomised, open label, blinded assessor, multiarm, phase IV study. Setting Twenty nine rheumatology departments in Sweden, Denmark, Norway, Finland, the Netherlands, and Iceland between 2012 and 2018. Participants Patients aged 18 years and older with treatment naive rheumatoid arthritis, symptom duration less than 24 months, moderate to severe disease activity, and rheumatoid factor or anti-citrullinated protein antibody positivity, or increased C reactive protein. Interventions Randomised 1:1:1:1, stratified by country, sex, and anti-citrullinated protein antibody status. All participants started methotrexate combined with (a) active conventional treatment (either prednisolone tapered to 5 mg/day, or sulfasalazine combined with hydroxychloroquine and intra-articular corticosteroids), (b) certolizumab pegol, (c) abatacept, or (d) tocilizumab. Main outcome measures The primary outcome was adjusted clinical disease activity index remission (CDAI≤2.8) at 24 weeks with active conventional treatment as the reference. Key secondary outcomes and analyses included CDAI remission at 12 weeks and over time, other remission criteria, a non-inferiority analysis, and harms. Results 812 patients underwent randomisation. The mean age was 54.3 years (standard deviation 14.7) and 68.8% were women. Baseline disease activity score of 28 joints was 5.0 (standard deviation 1.1). Adjusted 24 week CDAI remission rates were 42.7% (95% confidence interval 36.1% to 49.3%) for active conventional treatment, 46.5% (39.9% to 53.1%) for certolizumab pegol, 52.0% (45.5% to 58.6%) for abatacept, and 42.1% (35.3% to 48.8%) for tocilizumab. Corresponding absolute differences were 3.9% (95% confidence interval −5.5% to 13.2%) for certolizumab pegol, 9.4% (0.1% to 18.7%) for abatacept, and −0.6% (−10.1% to 8.9%) for tocilizumab. Key secondary outcomes showed no major differences among the four treatments. Differences in CDAI remission rates for active conventional treatment versus certolizumab pegol and tocilizumab, but not abatacept, remained within the prespecified non-inferiority margin of 15% (per protocol population). The total number of serious adverse events was 13 (percentage of patients who experienced at least one event 5.6%) for active conventional treatment, 20 (8.4%) for certolizumab pegol, 10 (4.9%) for abatacept, and 10 (4.9%) for tocilizumab. Eleven patients treated with abatacept stopped treatment early compared with 20-23 patients in the other arms. Conclusions All four treatments achieved high remission rates. Higher CDAI remission rate was observed for abatacept versus active conventional treatment, but not for certolizumab pegol or tocilizumab versus active conventional treatment. Other remission rates were similar across treatments. Non-inferiority analysis indicated that active conventional treatment was non-inferior to certolizumab pegol and tocilizumab, but not to abatacept. The results highlight the efficacy and safety of active conventional treatment based on methotrexate combined with corticosteroids, with nominally better results for abatacept, in treatment naive early rheumatoid arthritis. Trial registration EudraCT2011-004720-35, NCT01491815 .

Objective To investigate TNF inhibitor (TNFi) retention and response rates in European biologic-naïve patients with PsA. Methods Prospectively collected data on PsA patients in routine care from 12 European registries were pooled. Heterogeneity in baseline characteristics between registries were explored (analysis of variance and pairwise comparison). Retention rates (Kaplan–Meier), clinical remission [28-joint count DAS (DAS28) Results Overall, 14 261 patients with PsA initiated a first TNFi. Considerable heterogeneity of baseline characteristics between registries was observed. The median 12-month retention rate (95% CI) was 77% (76, 78%), ranging from 68 to 90% across registries. Overall, DAS28/28 joint Disease Activity index for Psoriatic Arthritis remission rates at 6 months were 56%/27% (LUNDEX: 45%/22%). Six-month ACR20/50/70 responses were 53%/38%/22%, respectively. In patients initiating a first TNFi after 2009 with registered fulfilment of ClASsification for Psoriatic ARthritis (CASPAR) criteria (n = 1980) or registered one or more swollen joint at baseline (n = 5803), the retention rates and response rates were similar to those found overall. Conclusion Approximately half of >14 000 patients with PsA who initiated first TNFi treatment in routine care were in DAS28 remission after 6 months, and three-quarters were still on the drug after 1 year. Considerable heterogeneity in baseline characteristics and outcomes across registries was observed. The feasibility of creating a large European database of PsA patients treated in routine care was demonstrated, offering unique opportunities for research with real-world data.

© The Author(s) 2020. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved., Objectives: To assess the impact of 'patient's minus evaluator's global assessment of disease activity' (ΔPEG) at treatment initiation on retention and remission rates of TNF inhibitors (TNFi) in psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) patients across Europe. Methods: Real-life data from PsA and axSpA patients starting their first TNFi from 11 countries in the European Spondyloarthritis Research Collaboration Network were pooled. Retention rates were compared by Kaplan-Meier analyses with log-rank test and by Cox regression, and remission rates by χ2 test and by logistic regression across quartiles of baseline ΔPEG, separately in female and male PsA and axSpA patients. Results: We included 14 868 spondyloarthritis (5855 PsA, 9013 axSpA) patients. Baseline ΔPEG was negatively associated with 6/12/24-months' TNFi retention rates in female and male PsA and axSpA patients (P

Background Discordance between baseline patient’s and evaluator’s global assessment of disease activity is common1 and may reduce the likelihood of remission following tumor necrosis factor inhibitor (TNFi) treatment in patients with psoriatic arthritis (PsA).2 However, the impact of such discordance on retention rates of TNFi in PsA patients remains unexplored. Objectives To explore the impact of discordance, defined as patient’s minus evaluator’s global assessment (ΔPEG), on retention rates and remission rates (DAS28(3)CRP (which does not include patient’s global) and DAS28(4)CRP (which includes patient’s global)) in PsA patients initiating their first TNFi treatment. We used pooled data from the European Spondyloarthritis Research Collaboration (EuroSpA). Methods TNFi naive PsA patients from 11 European registries in EuroSpA were included. Kaplan-Meier analyses were used to estimate TNFi retention rates after 6/12/24 months, with comparison between baseline ΔPEG quartiles using the log rank test, stratified by gender. Remission rates were compared between different ΔPEG quartiles with Chi-square test, stratified by gender. Results A total of 5422 PsA patients were included. Mean (SD) age for women(n=2988)/men(n=2867) were 49.3(12.5)/47.4(11.7) years, disease duration 6.6(7.3)/6.7(7.2) years, median(25-75 percentiles) baseline ΔPEG 17(0-38)/10(0-30) mm. Retention rates and DAS28(4)CRP but not DAS28(3)CRP remission rates were lower for higher quartiles of baseline ΔPEG (table, figure). Conclusion High baseline discordance (ΔPEG) was associated with lower TNFi retention rates and with DAS28(4)CRP but not DAS28(3)CRP remission rates after 6, 12 and 24 months’ follow-up in both male and female PsA patients. The choice of remission criteria in the follow-up of PsA patients may affect important treatment decisions, and may be of particular impact in patients with high baseline ΔPEG. References [1] Lindstrom, et al., J Rheumatol 2015;42:1781-5; 2 Michelsen, et al. Ann Rheum Dis 2016;76:708-11. Acknowledgement Novartis Pharma AG and IQVIA for supporting the EuroSpA collaboration.: Disclosure of Interests Brigitte Michelsen Grant/research support from: Unrestricted grant: Novartis, Consultant for: Novartis, UCB, Lykke Ornbjerg Grant/research support from: Unrestricted grant: Novartis, Heřman Mann Consultant for: Pfizer, Eli Lilly, Sanofi, Speakers bureau: AbbVie, Roche, Pfizer, MSD, Eli Lilly, Sanofi, Joseph Sexton: None declared, Michael Nissen Consultant for: AbbVie, Lilly, Novartis, and Pfizer, Maria Jose Santos: None declared, Dan Nordstrom Grant/research support from: MSD, Pfizer, Consultant for: AbbVie, BMS, MSD, Novartis, Roche, Pfizer, UCB, Speakers bureau: Novartis, UCB, Lennart T.H. Jacobsson Consultant for: LJ has received lecture and consulting fees from Pfizer, Abbvie, Novartis, Eli-Lily and Janssen, Ziga Rotar: None declared, Bjorn Gudbjornsson: None declared, Suleyman Serdar Koca: None declared, Catalin Codreanu: None declared, Manuel Pombo-Suarez: None declared, Irene van der Horst-Bruinsma Grant/research support from: MSD, Pfizer, AbbVie, Consultant for: Abbvie, UCB, MSD, Novartis, Speakers bureau: BMS, AbbVie, Pfizer, MSD, Anne Gitte Loft: None declared, Karel Pavelka: None declared, Eirik kristianslund: None declared, Burkhard Moeller Consultant for: Swissmedic Human Medicines Expert Committee Member (regulatory agency), Elsa Vieira-Sousa Grant/research support from: MSD, Novartis, Anna-Mari Hokkanen: None declared, Ulf Lindstrom: None declared, Matija Tomsic: None declared, Thorvardur Jon Love Consultant for: Received reimbursment from Celgene for speaking about guidelines for the treatment of psoriatic arthritis, Berna Goker: None declared, Ruxandra Ionescu: None declared, Carlos Sanchez-Piedra: None declared, Marleen van de Sande Grant/research support from: van Janssen, Novartis, Eli Lily, Consultant for: Novartis and Abbvie, Gary Macfarlane Grant/research support from: Have received research grants (not current) from Abbvie and Pfizer. Have received research grants (not current) from the British Society for Rheumatology, who received the funds from Abbive, Pfizer and UCB. Have received research grant (current) from the British Society for Rheumatology, who received the funds from Celgene., Florenzo Iannone: None declared, Lise Hyldstrup: None declared, Niels Steen Krogh: None declared, Mikkel Ǿstergaard Grant/research support from: Abbvie, Celgene, Centocor, Merck, Novartis, Consultant for: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, and UCB, Speakers bureau: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, and UCB, Merete L. Hetland Grant/research support from: BMS, MSD, AbbVie, Roche, Novartis, Biogen, Pfizer, Consultant for: Eli Lilly, Speakers bureau: Orion Pharma, Biogen, Pfizer, CellTrion, Merck, Samsung Bioepis

Background Tumour necrosis factor inhibitors (TNFi) are efficacious in patients with axial spondyloarthritis (axSpA), but some patients switch to a different TNFi because of adverse effects (AE) or lack of effect (LOE). The EuroSpA Collaboration has previously demonstrated a 1-year retention rate of 79% and 6 months LUNDEX adjusted BASDAI Objectives Firstly, to investigate retention and response rates at 6, 12 and 24 months in patients with axSpA initiating the 2nd and 3rd TNFi in clinical practice across Europe. Secondly, to investigate whether the outcomes were associated with the reason for withdrawal (AE or LOE) from the previous treatment. Methods Prospectively collected data on axSpA patients in routine care from 12 European registries were pooled. Kaplan-Meier estimation was used to investigate TNFi retention rates. LUNDEX adjusted2 response rates were calculated for BASDAI Results A total of 7953 patients initiating their 2nd TNFi and 2782 patients initiating 3rd TNFi were included. Baseline characteristics are shown in the Table. The overall retention rates for both 2nd and 3rd TNFi at 12 months were 72% (Figure). Corresponding retention rates for the individual registries ranged from 52-90% and 54-89%, respectively. In both patients who stopped 1st TNFi due to AE or LOE, 12-month retention rate for the 2nd TNFi treatment was 68%. In patients who stopped the 2nd TNFi due to AE or LOE, 12-month retention rates for the 3rd TNFi treatment were 68% and 69%, respectively. For the 2nd and 3rd TNFi, 6 months LUNDEX adjusted BASDAI Conclusion Data from 12 European countries demonstrated decreasing response rates with increasing number of previous TNFi, although with only minor difference between 2nd and 3rd. Patients who had withdrawn from the previous TNFi due to LOE had retention rates and remission rates similar to those who had withdrawn due to AE. References [1] Brahe, et al. ACR2018 [2] Arthritis Rheum, 2006, 54(2), p:600-6. Acknowledgement Novartis Pharma AG and IQVIA for supporting the EuroSpA collaboration Disclosure of Interests Lykke Ornbjerg Grant/research support from: Unrestricted grant: Novartis, Cecilie Heegaard Brahe Grant/research support from: Unrestricted grant: Novartis, Anne Gitte Loft: None declared, Johan Askling Grant/research support from: Karolinska Institutet (JA) has or has had research agreements with the following pharmaceutical companies, mainly in the context of the ATRIS national safety monitoring programme for rheumatology biologicals: Abbvie, BMS, MSD, Eli Lilly, Pfizer, Roche, Samsung Bioepis, and UCB., Consultant for: Karolinska Institutet has received remuneration for JA participating in ad boards arranged by Lilly, Novartis, and Pfizer., Adrian Ciurea Consultant for: AbbVie, Celgene, Janssen-Cilag, MSD, Eli Lilly, Novartis, Pfizer, UCB, Speakers bureau: Abbvie, Celgene, Janssen-Cilag, MSD, Eli Lilly, Novartis, Pfizer, UCB, Heřman Mann Consultant for: Pfizer, Eli Lilly, Sanofi, Speakers bureau: AbbVie, Roche, Pfizer, MSD, Eli Lilly, Sanofi, Servet Akar Grant/research support from: MSD, Abbvie, Roche, UCB, Novartis, Pfizer, Amgen, Consultant for: MSD, Abbvie, Roche, UCB, Novartis, Pfizer, Amgen, Speakers bureau: Pfizer, Eirik kristianslund: None declared, Dan Nordstrom Grant/research support from: MSD, Pfizer, Consultant for: AbbVie, BMS, MSD, Novartis, Roche, Pfizer, UCB, Speakers bureau: Novartis, UCB, Maria Jose Santos: None declared, Catalin Codreanu: None declared, Manuel Pombo-Suarez: None declared, Ziga Rotar: None declared, Bjorn Gudbjornsson: None declared, Daniela Di Giuseppe: None declared, Michael Nissen Consultant for: AbbVie, Lilly, Novartis, and Pfizer, Karel Pavelka: None declared, Soner Senel: None declared, Joe Sexton: None declared, Kari Eklund: None declared, Anabela Barcelos: None declared, Ruxandra Ionescu: None declared, Carlos Sanchez-Piedra: None declared, Matija Tomsic: None declared, Arni Jon Geirsson: None declared, Irene van der Horst-Bruinsma Grant/research support from: MSD, Pfizer, AbbVie, Consultant for: Abbvie, UCB, MSD, Novartis, Speakers bureau: BMS, AbbVie, Pfizer, MSD, Gary Macfarlane Grant/research support from: Have received research grants (not current) from Abbvie and Pfizer. Have received research grants (not current) from the British Society for Rheumatology, who received the funds from Abbive, Pfizer and UCB. Have received research grant (current) from the British Society for Rheumatology, who received the funds from Celgene., Florenzo Iannone Consultant for: F Iannone has received consultancy fees and/or speaker honoraria from Pfizer, AbbVie, MSD, BMS, Novartis, Lilly, UCB outside this work, Speakers bureau: F Iannone has received consultancy fees and/or speaker honoraria from Pfizer, AbbVie, MSD, BMS, Novartis, Lilly, UCB outside this work, Brigitte Michelsen: None declared, Lise Hyldstrup: None declared, Niels Steen Krogh: None declared, Merete L. Hetland Grant/research support from: BMS, MSD, AbbVie, Roche, Novartis, Biogen, Pfizer, Consultant for: Eli Lilly, Speakers bureau: Orion Pharma, Biogen, Pfizer, CellTrion, Merck, Samsung Bioepis, Mikkel Ǿstergaard Grant/research support from: Abbvie, Celgene, Centocor, Merck, Novartis, Consultant for: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, and UCB, Speakers bureau: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, and UCB

Background There is a lack of real-life data on secukinumab exposure, treatment outcomes and retention rates in axial spondyloarthritis (axSpA) patients. Objectives Primary objective: To assess the proportion of axSpA patients in BASDAI low disease activity ( Methods Data from axSpA patients treated with secukinumab in routine care from 12 countries in the European Spondyloarthritis Research Collaboration (EuroSpA) were pooled. Time from treatment initiation to data cut was >= 6 months. Group comparisons were performed with independent t-test, Mann-Whitney U-test, ANOVA, Kruskal-Wallis and Chi-square test, as appropriate. Kaplan-Meier analyses with log rank test were performed for comparison of secukinumab drug survival. Results A total of 1556 axSpA patients were included. Overall 6-month BASDAI Drug retention was higher for bDMARD naive compared with non-naive patients (figure 1a). Baseline characteristics and disease activity (data not shown) as well as drug retention differed in-between the European registries (figure 1b). Conclusion This study of >1500 patients in 12 European countries provides real-world data on the effectiveness of secukinumab in patients with axSpA, adding evidence to existing RCTs. A majority of the patients was previous bDMARD users and had long disease duration. BASDAI Acknowledgement Novartis Pharma AG and IQVIA for supporting the EuroSpA collaboration Disclosure of Interests Brigitte Michelsen Grant/research support from: Unrestricted grant: Novartis, Consultant for: Novartis, UCB, Cecilie Heegaard Brahe Grant/research support from: Unrestricted grant: Novartis, Johan Askling Grant/research support from: Karolinska Institutet (JA) has or has had research agreements with the following pharmaceutical companies, mainly in the context of the ATRIS national safety monitoring programme for rheumatology biologicals: Abbvie, BMS, MSD, Eli Lilly, Pfizer, Roche, Samsung Bioepis, and UCB., Consultant for: Karolinska Institutet has received remuneration for JA participating in ad boards arranged by Lilly, Novartis, and Pfizer., Catalin Codreanu: None declared, Adrian Ciurea Consultant for: AbbVie, Celgene, Janssen-Cilag, MSD, Eli Lilly, Novartis, Pfizer, UCB, Speakers bureau: Abbvie, Celgene, Janssen-Cilag, MSD, Eli Lilly, Novartis, Pfizer, UCB, Anne Gitte Loft: None declared, Heřman Mann Consultant for: Pfizer, Eli Lilly, Sanofi, Speakers bureau: AbbVie, Roche, Pfizer, MSD, Eli Lilly, Sanofi, Manuel Pombo-Suarez: None declared, Fatos Onen: None declared, Joe Sexton: None declared, Ziga Rotar: None declared, Maria Jose Santos: None declared, Kari Eklund: None declared, Bjorn Gudbjornsson: None declared, Florenzo Iannone Consultant for: F Iannone has received consultancy fees and/or speaker honoraria from Pfizer, AbbVie, MSD, BMS, Novartis, Lilly, UCB outside this work, Speakers bureau: F Iannone has received consultancy fees and/or speaker honoraria from Pfizer, AbbVie, MSD, BMS, Novartis, Lilly, UCB outside this work, Daniela Di Giuseppe: None declared, Ruxandra Ionescu: None declared, Michael Nissen Consultant for: AbbVie, Lilly, Novartis, and Pfizer, Karel Pavelka: None declared, Carlos Sanchez-Piedra: None declared, Servet Akar Grant/research support from: MSD, Abbvie, Roche, UCB, Novartis, Pfizer, Amgen, Consultant for: MSD, Abbvie, Roche, UCB, Novartis, Pfizer, Amgen, Speakers bureau: Pfizer, Eirik kristianslund: None declared, Matija Tomsic: None declared, Helena Santos: None declared, Nina Trokovic: None declared, Arni Jon Geirsson: None declared, Ennio Giulio Favalli: None declared, Irene van der Horst-Bruinsma Grant/research support from: MSD, Pfizer, AbbVie, Consultant for: Abbvie, UCB, MSD, Novartis, Speakers bureau: BMS, AbbVie, Pfizer, MSD, Gary Macfarlane Grant/research support from: Have received research grants (not current) from Abbvie and Pfizer. Have received research grants (not current) from the British Society for Rheumatology, who received the funds from Abbive, Pfizer and UCB. Have received research grant (current) from the British Society for Rheumatology, who received the funds from Celgene., Lise Hyldstrup: None declared, Niels Steen Krogh: None declared, Mikkel Ǿstergaard Grant/research support from: Abbvie, Celgene, Centocor, Merck, Novartis, Consultant for: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, and UCB, Speakers bureau: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, and UCB, Merete L. Hetland Grant/research support from: BMS, MSD, AbbVie, Roche, Novartis, Biogen, Pfizer, Consultant for: Eli Lilly, Speakers bureau: Orion Pharma, Biogen, Pfizer, CellTrion, Merck, Samsung Bioepis

Background The efficacy of Tumour Necrosis Factor inhibitor (TNFi) in patients with psoriatic arthritis (PsA) has been investigated in randomized controlled trials (RCTs) with strict inclusion and exclusion criteria. Patients treated in routine care are more heterogeneous and only ≈20-30% of patients receiving TNFi in routine care would have been eligible to be enrolled in the RCTs1. This emphasizes the need for real-world observational data as a valuable supplement to RCTs. Studying large patient groups from several European countries would increase the external validity of the results. Objectives To investigate Tumour Necrosis Factor inhibitor (TNFi) retention rates at 12 months (primary objective), 6 and 24 months, and remission rates at the same time-points in biologic-naive patients with PsA from the EuroSpA Collaboration. Methods Prospectively collected data on PsA patients from 12 European registries were uploaded through the secure Virtual Private Network pipelines to the EuroSpA server, and pooled. Baseline characteristics were investigated with non-parametric descriptive statistics. TNFi retention rates (Kaplan-Meier statistics), and 28-joint count Disease activity Score (DAS28) Results Overall, 14,261 patients with PsA initiated a 1st TNFi. Baseline characteristics of the pooled population are shown in the Table. The median 12-month retention rate (95%CI) was 77% (76-78%), ranging from 68-90% across registries (Figure). Overall, DAS28/DAPSA28 remission rates at 6 months were 56%/27% (LUNDEX-adjusted: 45%/22%). In patients initiating a 1stTNFi after 2009 with registered fulfillment of CASPAR criteria (n=1,980) or registered ≥1 swollen joint at baseline (n=5,803), the retention rates and remission rates were similar to those found overall (Table). Conclusion Approximately half of >14,000 patients with PsA who initiated 1st TNFi treatment in routine care were in DAS28-remission after 6 months, and three out of four were still on the drug after 1 year. References [1] Clin Exp Rheumatol, 2018, 36(6):1068-1073 [2] arthritis Rheum, 2006, 54(2): 600-6 Acknowledgement Novartis Pharma aG and IQVIA for supporting the EuroSpA collaboration. Disclosure of interests Cecilie Heegaard Brahe Grant/research support from: Unrestricted grant: Novartis, Lykke Ornbjerg Grant/research support from: Unrestricted grant: Novartis, Lennart T.H. Jacobsson Consultant for: LJ has received lecture and consulting fees from Pfizer, abbvie, Novartis, Eli-Lily and Janssen, Michael Nissen Consultant for: abbVie, Lilly, Novartis, and Pfizer, Eirik kristianslund: None declared, Heřman Mann Consultant for: Pfizer, Eli Lilly, Sanofi, Speakers bureau: abbVie, Roche, Pfizer, MSD, Eli Lilly, Sanofi, Maria Jose Santos: None declared, Manuel Pombo-Suarez: None declared, Dan Nordstrom Grant/research support from: MSD, Pfizer, Consultant for: abbVie, BMS, MSD, Novartis, Roche, Pfizer, UCB, Speakers bureau: Novartis, UCB, Ziga Rotar: None declared, Bjorn Gudbjornsson: None declared, Fatos onen: None declared, Catalin Codreanu: None declared, Ulf Lindstrom: None declared, Burkhard Moeller Consultant for: Swissmedic Human Medicines Expert Committee Member (regulatory agency), Joe Sexton: None declared, Karel Pavelka: None declared, anabela Barcelos: None declared, Carlos Sanchez-Piedra: None declared, Kari Eklund: None declared, Matija Tomsic: None declared, Thorvardur Jon Love Consultant for: Received reimbursment from Celgene for speaking about guidelines for the treatment of psoriatic arthritis, Gercek Can: None declared, Ruxandra Ionescu: None declared, anne Gitte Loft: None declared, Marleen van de Sande Grant/research support from: van Janssen, Novartis, Eli Lily, Consultant for: Novartis and abbvie, Irene van der Horst-Bruinsma Grant/research support from: MSD, Pfizer, abbVie, Consultant for: abbvie, UCB, MSD, Novartis, Speakers bureau: BMS, abbVie, Pfizer, MSD, Gary Macfarlane Grant/research support from: Have received research grants (not current) from abbvie and Pfizer. Have received research grants (not current) from the British Society for Rheumatology, who received the funds from abbive, Pfizer and UCB. Have received research grant (current) from the British Society for Rheumatology, who received the funds from Celgene., Florenzo Iannone Consultant for: F Iannone has received consultancy fees and/or speaker honoraria from Pfizer, abbVie, MSD, BMS, Novartis, Lilly, UCB outside this work, Speakers bureau: F Iannone has received consultancy fees and/or speaker honoraria from Pfizer, abbVie, MSD, BMS, Novartis, Lilly, UCB outside this work, Lise Hyldstrup: None declared, Niels Steen Krogh: None declared, Mikkel Ǿstergaard Grant/research support from: abbvie, Celgene, Centocor, Merck, Novartis, Consultant for: abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, and UCB, Speakers bureau: abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, and UCB, Merete L. Hetland Grant/research support from: BMS, MSD, abbVie, Roche, Novartis, Biogen, Pfizer, Consultant for: Eli Lilly, Speakers bureau: Orion Pharma, Biogen, Pfizer, CellTrion, Merck, Samsung Bioepis

Background Discordance between baseline patient’s and evaluator’s global assessment of disease activity is common.1 However, the impact of such discordance on retention and remission rates of TNF inhibitor (TNFi) therapy in axial spondyloarthritis (axSpA) patients remains unexplored. Objectives To assess the impact of baseline discordance, defined as “patient’s minus evaluator’s global assessment of disease activity” (ΔPEG), on retention and remission rates of first TNFi in female and male axSpA patients across Europe. Methods AxSpA patients from 10 European registries participating in the European Spondyloarthritis Research Network Collaboration (EuroSpA) were included. Retention rates after 6/12/24 months’ treatment with first TNFi were assessed with Kaplan-Meier analyses, with comparison between baseline ΔPEG quartiles with log rank test, stratified by gender. Proportions of patients in BASDAI remission (≤2) and ASDAS inactive disease ( Results A total of 9013 axSpA patients were included. Mean(SD) age for women(n=3639)/men(n=5374) were 42.7(12.0)/41.7(12.0) years, disease duration 5.1(7.4)/6.9(8.7) years, median(25-75 percentiles) baseline ΔPEG 20(3-42)/15(0-37) mm. TNFi retention rates and proportions of patients achieving BASDAI≤2 and ASDAS Conclusion In patients receiving their first TNFi, high baseline patient’s compared with evaluator’s global assessment is negatively associated with retention rates as well as proportions of patients achieving BASDAI remission and ASDAS inactive disease after 6, 12 as well as 24 months follow-up, both in female and male axSpA patients. References [1] Lindstrom, et al., J Rheumatol2015;42:1781-5. Acknowledgement Novartis Pharma AG and IQVIA for supporting the EuroSpA collaboration Disclosure of Interests Brigitte Michelsen Grant/research support from: Unrestricted grant: Novartis, Consultant for: Novartis, UCB, Lykke Ornbjerg Grant/research support from: Unrestricted grant: Novartis, Anne Gitte Loft: None declared, Joseph Sexton: None declared, Adrian Ciurea Consultant for: AbbVie, Celgene, Janssen-Cilag, MSD, Eli Lilly, Novartis, Pfizer, UCB, Speakers bureau: Abbvie, Celgene, Janssen-Cilag, MSD, Eli Lilly, Novartis, Pfizer, UCB, Heřman Mann Consultant for: Pfizer, Eli Lilly, Sanofi, Speakers bureau: AbbVie, Roche, Pfizer, MSD, Eli Lilly, Sanofi, Kari Eklund: None declared, Ayten Yazici: None declared, Maria Jose Santos: None declared, Johan Askling Grant/research support from: Karolinska Institutet (JA) has or has had research agreements with the following pharmaceutical companies, mainly in the context of the ATRIS national safety monitoring programme for rheumatology biologicals: Abbvie, BMS, MSD, Eli Lilly, Pfizer, Roche, Samsung Bioepis, and UCB., Consultant for: Karolinska Institutet has received remuneration for JA participating in ad boards arranged by Lilly, Novartis, and Pfizer., Ziga Rotar: None declared, Bjorn Gudbjornsson: None declared, Manuel Pombo-Suarez: None declared, Catalin Codreanu: None declared, Irene van der Horst-Bruinsma Grant/research support from: MSD, Pfizer, AbbVie, Consultant for: Abbvie, UCB, MSD, Novartis, Speakers bureau: BMS, AbbVie, Pfizer, MSD, Eirik kristianslund: None declared, Michael Nissen Consultant for: AbbVie, Lilly, Novartis, and Pfizer, Karel Pavelka: None declared, Nina Trokovic: None declared, Nevsun Inanc: None declared, Elsa Vieira-Sousa Grant/research support from: MSD, Novartis, Daniela Di Giuseppe: None declared, Matija Tomsic: None declared, Arni Jon Geirsson: None declared, Ruxandra Ionescu: None declared, Marleen van de Sande Grant/research support from: Research support from Janssen, Novartis, Eli Lily, Consultant for: Received consultation fees from Abbvie and Novartis, Florenzo Iannone Consultant for: F Iannone has received consultancy fees and/or speaker honoraria from Pfizer, AbbVie, MSD, BMS, Novartis, Lilly, UCB outside this work, Speakers bureau: F Iannone has received consultancy fees and/or speaker honoraria from Pfizer, AbbVie, MSD, BMS, Novartis, Lilly, UCB outside this work, Carlos Sanchez-Piedra: None declared, Gareth T. Jones Grant/research support from: Have received research grants (not current) from Abbvie and Pfizer. Have received research grants (not current) from the British Society for Rheumatology, who received the funds from Abbive, Pfizer and UCB. Have received research grant (current) from the British Society for Rheumatology, who received the funds from Celgene., Lise Hyldstrup: None declared, Niels Steen Krogh: None declared, Merete L. Hetland Grant/research support from: BMS, MSD, AbbVie, Roche, Novartis, Biogen, Pfizer, Consultant for: Eli Lilly, Speakers bureau: Orion Pharma, Biogen, Pfizer, CellTrion, Merck, Samsung Bioepis, Mikkel Ǿstergaard Grant/research support from: Abbvie, Celgene, Centocor, Merck, Novartis, Consultant for: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, and UCB, Speakers bureau: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, and UCB

Background There is a lack of data on exposure, treatment outcomes and retention rates of secukinumab in patients with psoriatic arthritis (PsA) treated in routine care. Objectives Primary objective: To assess the proportion of PsA patients in remission after 6 months of secukinumab treatment across Europe. Secondary objectives: To compare baseline clinical and demographic characteristics, 6-month crude and LUNDEX adjusted remission rates, 6-month retention rates and median time to secukinumab withdrawal (due to loss of efficacy/adverse events) between bDMARD naive and non-naive patients as well as across the participating European registries. Methods PsA patients starting secukinumab in routine care and followed for at least 6 months were included from 12 European registries within the European Spondyloarthritis Research Collaboration (EuroSpA). Independent t-test, Mann-Whitney U test, ANOVA, Kruskal-Wallis and Chi-square test were used for group comparisons as appropriate, and Kaplan-Meier plots with log rank test for comparison of secukinumab drug survival. Results A total of 1549 PsA patients starting secukinumab were included (Table). 6-month remission and retention rates were significantly different between the registries (Table). Biologic DMARD (bDMARD) naive compared with non-naive patients had significantly higher 6-month remission rates and a trend towards better 6-month retention rates (Table, Figure 1a-b). Conclusion This study of >1500 patients in 12 European countries provides real-world data on the effectiveness of secukinumab in patients with PsA, adding evidence to existing RCTs. A majority of the patients had long disease duration and was previous bDMARD users. DAS28CRP, SDAI and DAPSA28 remission at 6 months were achieved by 35%, 12% and 12%, respectively. The overall retention rate was 86%, with significant differences across the registries. bDMARD naive compared with non-naive patients had significantly better 6-month remission rates and a trend towards better secukinumab retention rates. Acknowledgement Novartis Pharma AG and IQVIA for supporting the EuroSpA collaboration Disclosure of Interests Brigitte Michelsen Grant/research support from: Unrestricted grant: Novartis, Consultant for: Novartis, UCB, Cecilie Heegaard Brahe Grant/research support from: Unrestricted grant: Novartis, Lennart T.H. Jacobsson Consultant for: LJ has received lecture and consulting fees from Pfizer, Abbvie, Novartis, Eli-Lily and Janssen, Michael Nissen Consultant for: AbbVie, Lilly, Novartis, and Pfizer, Manuel Pombo-Suarez: None declared, Heřman Mann Consultant for: Pfizer, Eli Lilly, Sanofi, Speakers bureau: AbbVie, Roche, Pfizer, MSD, Eli Lilly, Sanofi, Ziga Rotar: None declared, Joe Sexton: None declared, Maria Jose Santos: None declared, Dan Nordstrom Grant/research support from: MSD, Pfizer, Consultant for: AbbVie, BMS, MSD, Novartis, Roche, Pfizer, UCB, Speakers bureau: Novartis, UCB, Catalin Codreanu: None declared, Bjorn Gudbjornsson: None declared, Sema Yilmaz: None declared, Florenzo Iannone Consultant for: F Iannone has received consultancy fees and/or speaker honoraria from Pfizer, AbbVie, MSD, BMS, Novartis, Lilly, UCB outside this work, Speakers bureau: F Iannone has received consultancy fees and/or speaker honoraria from Pfizer, AbbVie, MSD, BMS, Novartis, Lilly, UCB outside this work, Ulf Lindstrom: None declared, Anne Gitte Loft: None declared, Burkhard Moeller Consultant for: Swissmedic Human Medicines Expert Committee Member (regulatory agency), Carlos Sanchez-Piedra: None declared, Karel Pavelka: None declared, Matija Tomsic: None declared, Eirik kristianslund: None declared, Helena Santos: None declared, Anna-Mari Hokkanen: None declared, Ruxandra Ionescu: None declared, Thorvardur Jon Love Consultant for: Received reimbursment from Celgene for speaking about guidelines for the treatment of psoriatic arthritis, Yavuz Pehlivan: None declared, Marco Sebastiani: None declared, Gareth T. Jones Grant/research support from: Have received research grants (not current) from Abbvie and Pfizer. Have received research grants (not current) from the British Society for Rheumatology, who received the funds from Abbive, Pfizer and UCB. Have received research grant (current) from the British Society for Rheumatology, who received the funds from Celgene., Irene van der Horst-Bruinsma Grant/research support from: MSD, Pfizer, AbbVie, Consultant for: Abbvie, UCB, MSD, Novartis, Speakers bureau: BMS, AbbVie, Pfizer, MSD, Lise Hyldstrup: None declared, Niels Steen Krogh: None declared, Merete L. Hetland Grant/research support from: BMS, MSD, AbbVie, Roche, Novartis, Biogen, Pfizer, Consultant for: Eli Lilly, Speakers bureau: Orion Pharma, Biogen, Pfizer, CellTrion, Merck, Samsung Bioepis, Mikkel Ostergaard Grant/research support from: Abbvie, Celgene, Centocor, Merck, Novartis, Consultant for: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, and UCB, Speakers bureau: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, and UCB

Background A research network collaboration of 15 European registries sharing data on patients with spondyloarthitis (SpA), “EuroSpA”, has recently been created to strengthen research capabilities in the real world setting1. Here we present the first results from the collaboration. Objectives To investigate the feasibility of creating a common database for axial SpA (axSpA), including non-radiographic SpA and ankylosing spondylitis, within the EuroSpA collaboration and to conduct proof-of-concept analyses by investigation of baseline characteristics, disease activity at baseline and after 6 months, and crude 12 months’ Tumour Necrosis Factor inhibitor (TNFi) retention rate in patients with axSpA initiating TNFi. Methods A common data model was agreed upon by the EuroSpA Scientific Committee. Virtual meetings between the EuroSpA and registry data managers clarified data availability and structure. This was followed by upload of anonymized data through the secure Virtual Private Network pipelines to the EuroSpA server. Baseline characteristics and disease activity at baseline and after 6 months were investigated with non-parametric descriptive statistics. Kaplan-Meier estimation was used to investigate TNFi retention rates. Results By January 8th 2018, four of the 15 registries participating in EuroSpA had completed data upload to the EuroSpA database resulting in 6756 patients with AxSpA in a pooled dataset. Baseline characteristics of the participating registry populations at initiation of first TNFi are shown in Table I. Crude 12 months’ TNFi retention rate varied from 66%–85% for 1 st TNFi and 61%–78% for 2nd TNFi (see figure 1). For the pooled dataset crude 12 months’ TNFi retention rates were 73% and 66% for the 1 st and 2nd TNFi, respectively. Conclusions Preliminary analyses showed differences across European registries regarding baseline characteristics and crude retention rates in axSpA patients initiating TNFi. These initial, preliminary analyses demonstrate that the creation of a large European database of axSpA patients treated in routine care based on a common data model is feasible, offering important opportunities for future research. Reference [1] Ann Rheum Dis2017;(suppl. 2):65. Acknowledgements The authors acknowledge Novartis Pharmaceuticals AG for financial support and Natasha Pillai and Carol Lines from QuintilesIMS and Craig Richardson from Novartis Pharmaceuticals AG for their assistance in setting up the EuroSpA collaboration. Disclosure of Interest L. Ornbjerg: None declared, M. Ostergaard: None declared, F. Onen: None declared, G. Can: None declared, Z. Rotar: None declared, M. Tomsic Consultant for: AbbVie, Eli Lilly, Johnson and Johnson, Medis, MSD, Novartis, Pfizer and Roche, B. Gudbjornsson: None declared, A. Geirsson: None declared, M. Santos: None declared, A. Barcelos: None declared, D. Nordstrom Consultant for: AbbVie, Celgene, BMS, Lilly, MSD, Novartis, Pfizer, UCB, K. Aaltonen: None declared, M. J. Nissen: None declared, A. Ciurea: None declared, E. Kristianslund: None declared, T. Kvien Grant/research support from: AbbVie, Biogen, BMS, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly, Epirus, Hospira, Merck-Serono, MSD, Mundipharma, Novartis, Orion Pharma, Hospira/Pfizer, Sandoz, UCB, C. Codreanu: None declared, E.-M. Hauge: None declared, L. Jacobsson: None declared, H. Mann: None declared, G. Jones: None declared, F. Iannone: None declared, M. V. Hernandez: None declared, I. van der Horst-Bruinsma: None declared, L. H. Hyldstrup: None declared, N. S. Krogh: None declared, M. Hetland Grant/research support from: AbbVie, Biogen, BMS, CellTrion, MSD, Orion, Pfizer, Samsung, UCB

Background A research network collaboration of 15 European registries collecting data on patients with spondyloarthitis (SpA), “EuroSpA”, has recently been created to strengthen research capabilities in the real world setting1. Here we present initial findings from the collaboration. Objectives To investigate the feasibility of creating a common database within the EuroSpA collaboration and to conduct proof-of-concept analyses by investigation of baseline characteristics, disease activity at baseline and after 6 months and 12 months’ TNFi retention rate in patients with psoriatic arthritis (PsA) initiating Tumour Necrosis Factor inhibitors (TNFi). Methods A common data model for PsA was agreed upon by the EuroSpA Scientific Committee. Virtual meetings between the EuroSpA and registry data managers clarified data availability and structure. This was followed by upload of anonymized data through the secure Virtual Private Network pipelines to the EuroSpA server. Baseline characteristics and disease activity at baseline and after 6 months were investigated with non-parametric descriptive statistics. Kaplan-Meier estimation was used to investigate TNFi retention rates. Results : By January 8th 2018, four of the 15 registries participating in EuroSpA had completed data upload to the EuroSpA database resulting in 3172 patients with PsA in a pooled dataset. Baseline characteristics of the participating registry populations at initiation of first TNFi are shown in table 1. Crude 12 month TNFi retention rates varied from 65%–80% for 1st TNFi and 57%–82% for 2nd TNFi (see figure 1). For the pooled dataset crude 12 months TNFi retention rates were 68% and 60% for the 1st and 2nd TNFi, respectively. Conclusions Preliminary analyses showed differences across European registries regarding baseline characteristics and crude retention rates in PsA patients initiating TNFi. These initial, preliminary analyses demonstrate that the creation of a large European database of PsA patients treated in routine care based on a common data model is feasible, offering important opportunities for future research. Reference [1] Ann Rheum Dis2017;2:65. Acknowledgements The authors acknowledge Novartis Pharmaceuticals AG for financial support and Natasha Pillai and Carol Lines from QuintilesIMS and Craig Richardson from Novartis Pharmaceuticals AG for their assistance in setting up the EuroSpA collaboration. Disclosure of Interest L. Ornbjerg: None declared, M. Ostergaard: None declared, F. Onen: None declared, M. Birlik: None declared, Z. Rotar: None declared, M. Tomsic Consultant for: AbbVie, Eli Lilly, Johnson and Johnson, Medis, MSD, Novartis, Pfizer and Roche, B. Gudbjornsson: None declared, T. Love: None declared, M. J. Nissen: None declared, A. Ciurea: None declared, D. Nordstrom Consultant for: AbbVie, Celgene, BMS, Lilly, MSD, Novartis, Pfizer, UCB, N. Trokovic: None declared, M. Santos: None declared, A. Barcelos: None declared, E. Kristianslund: None declared, T. Kvien Grant/research support from: AbbVie, Biogen, BMS, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly, Epirus, Hospira, Merck-Serono, MSD, Mundipharma, Novartis, Orion Pharma, Hospira/Pfizer, Sandoz, UCB, C. Codreanu: None declared, E.-M. Hauge: None declared, J. Askling: None declared, F. Iannone: None declared, H. Mann: None declared, M. V. Hernandez: None declared, G. Macfarlane: None declared, M. van de Sande: None declared, L. H. Hyldstrup: None declared, N. S. Krogh: None declared, M. Hetland Grant/research support from: AbbVie, Biogen, BMS, CellTrion, MSD, Orion, Pfizer, Samsung, UCB