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Background The introduction of biosimilars has been linked to concerns regarding their effectiveness and safety compared to their originator products. Whilst randomized controlled trials may address their relative efficacy, the outcome of biosimilars in clinical practice may be influenced by contextual factors, such as the treating rheumatology unit’s experience with biosimilars and non-medical switching. Objectives To analyze whether contextual factors, such as department size and use of biosimilars, and calendar period of treatment start, influence time until treatment discontinuation (i.e. drugsurvival) of biosimilars as compared to corresponding originator products. Methods We used data from the Swedish Rheumatology Quality register to identify all patients with rheumatoidarthritis, ankylosing spondylitis, psoriatic arthritis, or other spondyloarthropathies who started infliximab between March 1st 2015 and Sept 30th 2017 or etanercept between April 1st 2016 and Sept 30th 2017, as their firstever biologic. Kaplan-Meier curves and Cox models were used to assess the association between drug survival and the size of the rheumatology unit, itsuse of biosimilars (extent of biosimilar use above/below national median a teach time point), and whether the treatment start occurred soon after biosimilar introduction (infliximab: first 12 months, etanercept: 6 months counting from first date of availability of the biosimilar in question). To avoid artefacts, patients were censored if switching from the originator to a biosimilar (or vice versa). Results During the study period, 368 and 738 patients started infliximab originator or biosimilar, and 125 and 2079 started etanercept originator or biosimilar, as first ever biological treatment. Overall, the hazard ratio (HR) of discontinuing treatment (comparing the biosimilar vs its originator) was 1.21 (95% CI: 0.96–1.51) for infliximab and 0.88 (95% CI: 0.57–1.35) for etanercept, adjusted for indication, age(quartiles), gender, region, and HAQ (quartiles), DAS28 (quartiles) and globalhealth (quartiles) at treatment start. Patients treated in large clinics (more than 1695 patients (75th percentile) at the end of the study period) were at a lower risk of drug discontinuation (table 1). We noted no association between overall biosimilar use in the rheumatology clinic in question and survival on drug (neither originator nor biosimilar). By contrast, those who started infliximab biosimilar later had a lower risk of discontinuing (HR: 0.65 (95% CI:0.50–0.85)) compared to those who started in the first year of availability. For etanercept biosimilar, no such association was noted. Conclusions Contextual factors, presumably related to expectations and differences in clinical monitoring, influence the observed survival on drug of biologics, including biosimilars, and must be considered when the comparative effectiveness of biosimilars is evaluated. Disclosure of Interest D. DiGiuseppe: None declared, T. Frisell: None declared, E. Lindqvist: None declared, L. Jacobsson Consultant for: received lecture and consulting fees from Pfizer, Abbvie and Novartis, C. Turesson Grant/research support from: Abbvie, Bristol Myers-Squibb, Roche, Consultant for: MSD, Bristol Myers-Squibb, Roche, Paidinstructor for: Abbvie, Bristol-Myers Squibb, Janssen, MSD, Pfizer, Roche and UCB, C. Sjowall: None declared, J. Askling Grant/research support from: has orhas had research agreements with Abbvie, BMS, MSD, Pfizer, Roche, Astra-Zeneca, Eli Lilly, Samsung Bioepis, and UCB, mainly in the context of safety monitoring of biologics via ARTIS. Karolinska Institutet has received remuneration for JA participating in advisory boards arranged by Pfizer and Eli Lilly.

Background Many current guidelines rank abatacept (ABA), rituximab (RTX), tocilizumab (TOC), and the TNFi bDMARDs as equal in effectiveness for the treatment of RA, at least as second line therapies. This is mainly based on evidence from separate RCTs, with few direct comparisons and limited comparative effectiveness data from clinical practice. Objectives To describe outcomes in clinical practice among RA patients starting different bDMARDs as first bDMARD, and after switch from initial TNFi. Methods The Swedish Rheumatology Register was linked to nationwide registers with data on demographics and medical history. We included all patients with RA starting a first ever bDMARD, or switching to a new bDMARD after a TNFi as first bDMARD, in 2010 - 2014, with follow-up through 2015. Effectiveness was assessed at 1 year (±90 days) after starting therapy, and measured as 1) the proportion remaining on therapy, or the proportion remaining on therapy and with 2) Good EULAR response, 3) HAQ improvement >0.2, 4) no swollen or tender joints. Relative response was estimated with log-binomial regression adjusting for potential confounders. Results Patients starting non-TNFi were older than those starting a TNFi, had lower socioeconomic status, and more often a history of diseases including malignancy, serious infections, and diabetes. After switch from TNFi, those starting non-TNFi also had higher disease activity. Non-TNFi were associated with better drug survival and higher proportion reaching response outcomes compared to TNFi as first bDMARD. After switch from TNFi, RTX and TOC, but not ABA, were associated with significantly better drug survival and response. Differences remained after adjusting for identified potential confounders. Conclusions Despite channeling of older and sicker individuals to non-TNFi-bDMARDs, treatment outcomes were in general better in these groups, particularly for TOC and RTX. In interpreting this, the risk of residual confounding should be remembered, and that we did not include safety or long term outcomes. Acknowledgements The ARTIS registry has been, or is, supported by agreements with Abbvie, BMS, MSD, Pfizer, Roche, Samsung, and UCB. Disclosure of Interest T. Frisell: None declared, M. Dehlin: None declared, D. Di Giuseppe: None declared, N. Feltelius: None declared, A. Kastbom Consultant for: Bristol-Myers Squibb, Pfizer, Roche, UCB, Paid instructor for: Bristol-Myers Squibb, Pfizer, Roche, UCB, C. Turesson Grant/research support from: Abbvie, Pfizer, Roche, Consultant for: MSD, Pfizer, Roche, Paid instructor for: Abbvie, Bristol-Myers Squibb, Janssen, MSD, Pfizer, Roche and UCB, J. Askling Grant/research support from: Abbvie, UCB, Pfizer, Merck, Samsung, Roche, Lilly

Confounding by indication will make NON-TNFI BDMARDS appear more harmful than TNFI bdmards - a nationwide study of channeling in sweden 2010-2014

Background Psoriatic arthritis (PsA) is a chronic inflammatory disorder associated with skin and joint manifestations, several extra-articular symptoms, various comorbidities, and disability. The emergence of tumour necrosis factor inhibitor (TNFi) therapy has dramatically changed the course of disease. Over the past decade new TNFi therapies have emerged (certolizumab pegol and golimumab), and recently ustekinumab and secukinumab have also become available for PsA. Objectives The objective of this study was to assess the relative use of biological agents (bDMARDs) in PsA from 2006 through 2014, using data from the Nordic Rheumatology registers. Methods Based on data from the observational registers DANBIO, ICEBIO, NOR-DMARD, ROB-FIN, and SRQ registers, PsA patients initiating treatment with bDMARDs as a first or subsequent biological therapy were identified. Adalimumab, etanercept and infliximab were grouped as “first generation TNFi therapies”; certolizumab pegol and golimumab were grouped as “second generation TNFi”. Treatments with ustekinumab during the study period were also identified. Descriptive statistics for prescription patterns of bDMARD therapy were calculated. Results A total of 11,458 treatment initiations were identified (DANBIO 3,068, ICEBIO 357, NOR-DMARD 1,113, ROB-FIN 708, SRQ 6,212). 54% of the patients were female. Overall, 5,695 patients initiated a first generation TNFi, 912 a second generation TNFi, and 16 ustekinumab, as their first course of biological treatment. The corresponding numbers for those initiating a second (or more) biological treatment were 3,606, 1,090 and 139 patients, respectively. The figure displays the annual number of treatment initiations stratified by treatment type. The total yearly number of first course biological treatment increased significantly throughout the period (p Conclusions Across the Nordic countries the prescription pattern for biological therapies for PsA has changed significantly over time. After 2012 initiation of the first generation TNFi is decreasing both as first and second course therapy, whereas second generation TNFi are increasing both as first and second course of biologic intervention. Collaboration across registers will allow for robust assessment of the uptake of newer biological therapies. Acknowledgements This study was partly funded by a grant from NordForsk and Janssen Pharmaceuticals. Disclosure of Interest T. S. Jorgensen Speakers bureau: Abbvie, Roche, Novartis, UCB, Biogen, L. Dreyer Speakers bureau: MSD, UCB and Janssen Pharmaceuticals, B. Guðbjornsson Speakers bureau: Actavis, Celgene, MSD, Pfizer, M. Hetland Speakers bureau: BMS, MSD, AbbVie, Roche, Eli Lilly, Pfizer, Orion, Novartis, B. Glintborg Speakers bureau: Abbvie, J. Askling Grant/research support from: AstraZeneca, UCB, Lilly, Pfizer, Roche, Merck,Samsung, Janssen, K. Chatzidionysiou Speakers bureau: AbbVie, Pfizer, Eli Lilly, UCB, Roche., D. Di Giuseppe: None declared, L. Jacobsson Consultant for: Abbvie, Celegen, MSD, Novartis and UCB, J. Wallman Consultant for: Novartis, Celgene, UCB, E. Kristianslund: None declared, I. Olsen: None declared, K. Fagerli: None declared, E. Lie Speakers bureau: AbbVie, Celgene, Hospira and Pfizer., D. Nordstrom Speakers bureau: AbbVie, BMS, Lilly, MSD, Novartis, Pfizer, Roche, UCB., K. Aaltonen: None declared, J. Joensuu Speakers bureau: Pfizer., T. J. Love: None declared, A. J. Geirsson: None declared, L. E. Kristensen Speakers bureau: Pfizer, AbbVie, Amgen, UCB, Celgene, BMS, MSD

Validation of internet-based reporting of patient reported outcomes within the swedish rheumatology quality register

Assessment of biosimilars using real world data : the complexity of choosing a comparator and understanding uptake