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Background: The study was based on the Danish DANBIO and the Norwegian NOR-DMARD databases. Objective: To investigate changes in prescription practice during the first 3 years of post-marketing use of biological drugs, and to determine the proportion of patients who would not have received tumour necrosis factor (TNF) blocking agents if the prescription guidelines of the UK and the Netherlands had been applied. Methods: Patients with rheumatoid arthritis (RA) receiving TNF blocking agents from Denmark (n = 823, median age 56.0, 72.2% women) and Norway (n = 371, median age 52.5, 75.4% women) were studied. Prescription guidelines in the UK and the Netherlands were applied to the data. Results: Baseline disease activity and number of previous DMARDs declined significantly during the 3 years (median baseline DAS28 decreased from 5.8 to 5.2 in Denmark (p,0.001) and from 6.0 to 5.6 in Norway (p,0.01)). 47.9% and 41.3% of the Norwegian and Danish patients, respectively, did not meet the UK criteria for using TNF blocking agents, and 10.5% and 5.7% did not meet the Dutch criteria. Conclusion: Danish and Norwegian prescription practices of biological treatments in RA were similar, and became less stringent from 2000 to 2003. Prescriptions agreed well with the Dutch guidelines, but almost half the patients did not meet the UK guidelines.

BackgroundAccording to national guidelines issued in 2015, a non-medical switch from originator infliximab (IFX) (Remicade) to biosimilar Remsima was conducted in all Danish patients with inflammatory rheumatic diseases treated in routine care.ObjectivesTo investigate 3 months' clinical outcomes in Remicade-treated patients (pts) with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthrits (SpA) who switched to Remsima and were monitored prospectively in the DANBIO registry.MethodsDisease activity at 3 mths before switch (pre-switch), at the switch and after 3 mths (70–120 days) (post-switch) and changes over time (Δpre-switch and Δpost-switch) were calculated. Disease flare was defined as ΔDAS28≥1.2 (RA/PsA) or ΔASDAS≥1.3 (SpA). Reasons for withdrawal (adverse events (AE), lack of effect (LOE) or other) were registered.Results647 of 693 switching pts (300 RA, 96 PsA, 219 SpA, 32 other) had available data (52% women, age (median (IQR) 56 (45–66) yrs)). Prior Remicade treatment duration was 6.7 (4.1–9.4) yrs and in 77% it was the first biological treatment. Remsima dose was in RA+PSA 3.3 (3.0–4.8) mg/kg every 7 (6–8) wks and in SpA 4.8 (3.6–5.1) mg/kg every 6 (6–9) wks. Concomitant MTX was given in 69% (RA+PsA)/25% (SpA). Median follow-up time was 139 (98–160) days.Disease activity remained largely unchanged 3 months prior to vs. after the switch (Table). The proportion of patients with disease flare pre-/post switch was 10%/10% (RA+PsA) (p=1.0) and 10%/0% (SpA) (p=1.0) (related samples McNemar test).Overall, 45 ptts (7%) stopped Remsima treatment during follow-up (AE 16 (allergic 3, infection 2, rash 2, unspecific 9), LOE 20, remission 3, cancer 2, other 4). Prior Remicade treatment duration in these patients was 5.9 (3.5–9.1) yrs.Table 1Disease activity, median (IQR)Delta-values, median (IQR)P*3 monthsSwitch3 monthsPre-switchPost-switchpre-switchpost-switchRA/PSA DAS282.3 (1.8–3.0)2.3 (1.8–3.2)2.3 (1.9–3.2)0.0 (−0.3–0.5)0.1 (−0.2–0.5)0.07 HAQ0.6 (0.1–1.1)0.6 (0.1–1.1)0.5 (0.3–1.1)0.0 (0.0–0.1)0.0 (−0.1–0.1)0.5 CRP, mg/l4 (2–7)4 (2–8)6 (3–9)0 (−2–1)0 (−1–3)0.03 VAS pt's global, mm26 (11–52)27 (11–56)26 (11–55)0 (−7–8)0 (−7–9)0.04SpA BASDAI, mm26 (12–47)23 (7–41)23 (7–41)0 (−4–5)0 (−3–3)0.5 CRP, mg/l4 (1–8)2 (1–5)5 (1–9)0 (−2–2)0 (−2–2)0.5 VAS pt's global, mm28 (15–57)31 (15–56)24 (10–52)1 (−4–8)−2 (−9–2)0.3 ASDAS2.0 (1.3–2.7)1.9 (0.7–3.2)1.8 (1.2–2.7)0.0 (−0.3–0.5)0.0 (−0.4–0.2)0.8*Delta values for disease activity pre-switch vs. post-switch, Wilcoxon matched-pair signed rank test.ConclusionsIn 647 patients with inflammatory rheumatic diseases treated with Remicade for >4 years, disease activity was largely unaffected in the majority of patients 3 months after non-medical switch to biosimilar Remsima and comparable to the fluctuations observed in the 3 months prior to the switch. However, several patients (∼6%) stopped treatment due to LOE or AE. This warrants further investigation before such a non-medical switch can be recommended.Disclosure of InterestNone declared

BackgroundIn Denmark, patients (pts) treated with originator etanercept (ETA) 50 mg SC conducted a mandatory non-medical switch to biosimilar SB4 in April 2016 (switchers). Pts treated with 25 mg ETA or 50 mg powder-solution were not mandated to switch (non-switchers). Some switchers resumed ETA during follow-up (back-switchers).ObjectivesTo investigate the frequency of back-switching after the non-medical switch from ETA to SB4, and in back-switchers to study, 1) baseline characteristics at the time of initial switch (ETA->SB4), 2) reasons for SB4 withdrawal, 3) changes in disease activity during treatment with SB4 and after back-switching.MethodsPatient data were retrieved from the DANBIO registry (censored August 2017). For back-switchers, disease activity at the start of SB4 (=baseline) and at the time of back-switching to ETA were compared, and changes in disease activity between the two time points were calculated (=delta values), stratified by indication (RA/PsA/AxSpA). Baseline characteristics of back-switchers were compared to the rest of the switch population (Chi-sq, Mann-Whitney U-test). Abbreviations are shown in table 1.Results1641 pts switched from ETA to SB4. Of these, 299 (18%) withdrew SB4 therapy during 1 year follow-up and either switched back to ETA (n=120, 7%), started another bDMARD (n=104), died (n=9), were lost to follow-up (n=1) or did not re-start bDMARDs (n=65).Among the 120 back-switchers, SB4 was withdrawn due to LOE (52%), AE (39%), or other/unknown reasons (9%). The reasons for withdrawal of SB4 in back-switchers are listed in table 1. No major safety events occurred. The median time on SB4 before back-switching was 120 (IQR 73–193) days, and the time between stop of SB4 and re-start of ETA was 11–1 days. Baseline characteristics of back-switchers vs the rest of the switch population were similar (all p>0.05).Among back-switchers who stopped SB4 due to LOE, PGA increased during SB4 treatment, whereas CRP and SJC were largely unchanged (table 1). At the date of censoring, 104/120 back-switchers (87%) were still treated with originator ETA (median treatment duration 236 (155–302) days).Abstract FRI0103 – Table 1Description of ETA-SB4-ETA back-switchers (n=120)ConclusionsIn a nationwide cohort of 1621 arthritis patients that were switched from ETA to SB4, 7% switched back to ETA. Back-switchers had no distinct clinical or disease characteristics upon start of SB4. AEs prior to back-switching were largely unspecific. In pts who withdrew SB4 due to LOE, PGA had increased. Reasons for back-switching appeared to be predominantly subjective rather than objective (nocebo effect). Originator drug was still available (25 mg or 50 mg powder-solution), which may have encouraged back-switching.References[1] Glintborg, et al. Arthritis Rheum2017;69(suppl 10).[2] Glintborg, et al. Abstract, EULAR2018.AcknowledgementsPartly sponsored by BiogenDisclosure of InterestB. Glintborg Grant/research support from: Abbvie, Biogen, Pfizer, I. Sørensen: None declared, E. Omerovic: None declared, F. Mehnert: Non...

BackgroundIn Denmark, biological treatments (bDMARDs) are tax paid. Since year 2013, The Danish Council for the Use of Expensive Hospital Medicines (RADS) has issued recommendations with annual updates regarding RA patients (pts) initiating biological treatment, dictating a mandatory choice of the cheapest bDMARD (1). Furthermore, the percentage of pts expected to be treated according to the RADS recommendation per year is stated. For pts treated with concomitant methotrexate (MTX) recommendations on first line, first choice bDMARD were: Jan 1th 2013-June 30th 2014: certolizumab pegol (in 80% of pts); July 1th 2014 - June 30th 2015: abatacept (80%); July 1th 2015-June 30th 2016: biosimilar infliximab (CT-P13) (50%). The nationwide Danish DANBIO registry collect data prospectively and covers >90% of adults with rheumatological diseases treated with bDMARDs in routine care (2).ObjectivesTo characterize Danish RA pts initiating first line, first choice treatment with a bDMARD in combination with MTX in the three RADS periods and to explore the degree of compliance to RADS recommendations. Furthermore, to investigate differences in baseline characteristics between those pts who were compliant to RADS guidelines and those who were not.MethodsFor each of the three RADS' periods bio-naive pts with RA were identified in DANBIO and compliance to RADS recommendations was assessed. Baseline characteristics of those who started first choice bDMARD treatment according to RADS were compared with those who started another biologic instead. Comorbidities and previous hospitalized infections were identified in the Danish National Patient Registry. Comorbidities from Charlson Comorbidity Index were summarized except category number 7, connective tissue disease.ResultsFor all three RADS periods, age, gender, functional status and disease activity were typical for pts with RA. Age was median: 57 years, range 18–88 years and disease duration: 3 years, range 0–54 years. 16–22% of pts had ≥1 comorbidity and 7–9% had ≥1 hospitalized infection the previous year. In each of the three RADS periods, 71%, 66% and 60% of pts followed the RADS recommendations, respectively (Table). The table shows differences between those who started first choice bDMARD treatment according to RADS, and those who did not. Overall, pts who complied to RADS had higher DAS28 and patient VAS global. Characteristics of pts who followed RADS recommendations in the three periods appeared similar.ConclusionsIn this nationwide study of >600 RA pts, pts' clinical characteristics were more heterogeneous than in clinical trials, reflecting routine care. Overall, compliance to recommendations was good. Thus, the national guidelines in Denmark with mandatory choice of the first biological drug may provide an interesting opportunity to study effectiveness of bDMARDs in routine care. This highlights observational studies as a valuable supplement to RCTs.References The Danish Council for the Use of Expensive Hospital medicines (RADS), Hetland ML. Rehumatology 2011;50:69–77. Di...