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Objective: Pain is a common and distressing feature of juvenile idiopathic arthritis (JIA). Pain interference (PI) is underexplored in long-term conditions such as JIA. The aim of this study was to...

Objectives: Across diagnosis groups, successful transition of adolescent and young adults from children's hospitals to adult care is often associated with decreased treatment adherence and treatment results. The aim of this study was to characterize disease activity and anti-rheumatic medications following transfer of care of juvenile idiopathic arthritis (JIA) patients to the adult clinic.Method: All consecutive JIA patients aged 16-20 years who visited the specific transition clinic in the rheumatology outpatient clinic of Helsinki University Hospital between November 2012 and May 2013 and between April 2015 and April 2016 were evaluated.Results: A total of 214 patients were identified, and 23 appeared in both cohorts. Females had higher disease activity scores (DAS) than males (DAS28-CRP 1.90.7 versus 1.6 +/- 0.3, p=.019; and DAS44-CRP 1.0 +/- 0.7 versus 0.7 +/- 0.5, p=.005; respectively) in the latter cohort. Disease-modifying antirheumatic drugs (DMARDs) were prescribed to 86% of patients, and 48% were on biological DMARDs (bDMARDs), whereas 14% had no specific treatments.Conclusion: Disease activity and clinic attendance remained stable during the transition period. The proportion of transition phase JIA patients on bDMARDs was high and disease activity was low. Reasons for lower disease activity in males in the latter cohort require further investigation.

Purpose To model the American College of Rheumatology (ACR) outcomes, cost-effectiveness, and budget impact of certolizumab pegol (CZP) (with and without a hypothetical risk-sharing scheme at treatment initiation for biologic-naïve patients) versus the current mix of reimbursed biologics for treatment of moderate-to-severe rheumatoid arthritis (RA) in Finland. Methods A probabilistic model with 12-week cycles and a societal approach was developed for the years 2015–2019, accounting for differences in ACR responses (meta-analysis), mortality, and persistence. The risk-sharing scheme included a treatment switch and refund of the costs associated with CZP acquisition if patients failed to achieve ACR20 response at week 12. For the current treatment mix, ACR20 at week 24 determined treatment continuation. Quality-adjusted life years were derived on the basis of the Health Utilities Index. Results In the Finnish target population, CZP treatment with a risk-sharing scheme led to a estimated annual net expenditure decrease ranging from 1.7% in 2015 to 5.6% in 2019 compared with the current treatment mix. Per patient over the 5 years, CZP risk sharing was estimated to decrease the time without ACR response by 5%-units, decrease work absenteeism by 24 days, and increase the time with ACR20, ACR50, and ACR70 responses by 5%-, 6%-, and 1%-units, respectively, with a gain of 0.03 quality-adjusted life years. The modeled risk-sharing scheme showed reduced costs of €7866 per patient, with a more than 95% probability of cost-effectiveness when compared with the current treatment mix. Conclusion The present analysis estimated that CZP, with or without the risk-sharing scheme, is a cost-effective alternative treatment for RA patients in Finland. The surplus provided by the CZP risk-sharing scheme could fund treatment for 6% more Finnish RA patients. Funding UCB Pharma. Electronic supplementary material The online version of this article (doi:10.1007/s12325-017-0614-8) contains supplementary material, which is available to authorized users.

To describe a cohort of Finnish juvenile idiopathic arthritis (JIA) patients, to recognize those young adults who are at risk of becoming socially restricted by their long-term rheumatic disease, and to assess which areas of self-rated health-related quality of life (HRQoL) are associated with the emergence of restricted social participation.A total of 195 young adults with JIA completed questionnaires addressing demographics, health behaviour, physical activity, functional ability, HRQoL, depressive symptoms, and self-esteem. Patients were classified as having non-restricted social participation if they were engaged in studying, working, maternity leave, or military service, and restricted social participation if they were unemployed or on disability pension.Of the patients, 162 (83%) were considered as having non-restricted social participation and 33 (16%) restricted social participation. Among patients with restricted social participation, five (15%) were on disability pension and 28 (85%) were unemployed. Patients with restricted social participation participated less in leisure-time non-physical activities (p = 0.033), felt more disturbed during their leisure time (p = 0.010), had lower self-esteem (p = 0.005), and had higher disability scores (p = 0.024). HRQoL scores revealed statistically significant differences between the groups: physical functioning (p = 0.043), social functioning (p = 0.016), and emotional well-being (p = 0.049) were all lower in patients with restricted social participation.Socially restricted patients showed a higher degree of disability, and lower levels of physical functioning, self-esteem, emotional well-being, and social functioning. These patients should be recognized earlier and interventions provided to enhance their social participation.

Background Raynaud9n phenomenon (RP) is very common all around the world, especially in cold climates (from 3 to 22%) (1). Nailfold capillaroscopy and autoantibodies have a pivotal role in diagnosing of different diseases in the context of RP (2).This is a first study of patients with RP in Finnish tertiary care hospitals. Objectives Aim is to investigate nailfold videokapillaroskopy (NVC) findings and autoantibody-values in patients with Raynaud9s phenomenon first time in Finnish prospective multicenter study cohort. Methods We enrolled consecutive 160 patients with Raynaud9s phenomenon who underwent NVC 9/2012–4/2013. Nailfold capillaries of II-V fingers of both hands were examined by using an optical probe videokapillaroskope mounted with x200 magnification lens. Images where analyzed with Videocapt software (DS Medigroup, Milan, Italy). NVC findings were classified with qualitative scoring, and early, active and late patterns were classified as“scleroderma pattern”. Serum levels of antinuclear antibodies (ANA), antitopoisomerase I antibodies (anti-Scl-70) and anticentromere antibodies (ACA) were analyzed. Clinical and epidemiological features were reviewed. Results The mean age of the patients was 50, 4 years (±14, 8 SD), range 19–81 years, and 79, 4% were female. 15, 6% of patients were smokers and 3 had diabetes. Reasons for performing of NVC can be divided into three categories: (i) assessment of disease activity in previously diagnosed scleroderma (n=26), (ii) differential diagnosis of Raynaud9s phenomenon (n=98), and (iii) assessment of Raynaud9s phenomenon in other rheumatic diseases (n=36). In group ii mean age was 48, 6 years (±14, 6 SD), 77, 6% were female and 17,3% were smokers. In this group 26, 5% (n=26) were diagnosed with scleroderma or there was strong suspicion of scleroderma at the first consultation of this study, 52% (n=51) were diagnosed with primary Raynaud9s phenomenon and 21, 5% (n=21) were diagnosed with some other rheumatic disease (MCTD (n=2), Sjogren9s syndrome (n=3), SLE (n=4), UCTD (n=8) and rheumatic arthritis (n=4)). Among those patients who was diagnosed with scleroderma, only 4% (n=1) had normal NVC pattern, 76,0% had scleroderma pattern (n=19) and 20,0% (n=5) had other non-specific changes. 19,2% (n=5) had low titers of ANA, 7,7% (n=2) had medium titers of ANA and 76,0% (n=19) had high titers of ANA. 69, 2% (n=18) had anticentromere antibodies (ACA) and 3, 8% (n=1) had antitopoisomerase I antibodies (anti-Scl-70). Those patients who had positive ACA or anti-Scl-70 also had a NVC scleroderma-pattern. Conclusions The main reason for NVC in this cohort was differential diagnosis of Raynaud9s phenomenon, and in most patients in diagnostic group primary Raynaud9s phenomenon was diagnosed. NVC is useful method for differential diagnosis of Raynaud9s phenomenon. References Spencer-Green, George. Outcomes in primary Raynaud phenomenon: a meta-analysis of the frequency, rates, and predictors of transition to secondary diseases. Archives of internal medicine 158.6 (1998): 595–600. Ingegnoli, Francesca, et al. Improving outcome prediction of systemic sclerosis from isolated Raynaud9s phenomenon: role of autoantibodies and nail-fold capillaroscopy. Rheumatology (2010): kep447. Disclosure of Interest None declared

Intra-articular glucocorticoid injections are the recommended treatment for active arthritis, but accurate positioning of the needle may be challenging. Inexperienced physicians might decide not to inject because an unsuccessful injection impairs clinical outcome and may lead to complications; however, choosing not to inject may impair or delay the best possible treatment. Here, we address this problem by introducing a novel Bioimpedance Probe (BIP) Needle-guidance method that was tested in a clinical study. The BIP Needle was utilized for detection of synovial fluid. It measures real-time bioimpedance spectra and identifies when the needle tip is in contact with the synovial fluid. Injections into 80 joints with active arthritis were performed by an experienced rheumatologist using the BIP Needle. The location of the BIP Needle was ensured by aspiration of synovial fluid, absence of resistance during injection, and/or using real-time ultrasound imaging. Sensitivity and specificity of the device for synovial fluid detection were 86 % (CI 75-93 %) and 85 % (CI 74-92 %), respectively. The BIP Needles showed high spatial resolution and differentiated the synovial fluid from the surrounding tissues. However, lack of synovial fluid, anatomic variability, and intra-articular structures challenged the technology. The BIP Needles provided adequate results in intra-articular injections. Performance of the device was good even in small joints, which may be the most difficult for inexperienced physicians. Further performance improvement can be expected when more data is collected for mathematical models. Overall, this novel method showed potential to be used in real-time needle guidance.

ObjectiveEarly treatment of patients with rheumatoid arthritis (RA) with combination treatment starting with methotrexate, sulfasalazine, hydroxychloroquine and prednisolone (FIN-RACo strategy) is superior to monotherapy. A study was undertaken to determine whether infliximab (INFL) added to intensified FIN-RACo treatment for the initial 6 months improves the 2-year outcome.Methods99 patients with early untreated active RA were enrolled in an investigator-initiated, randomised, double-blind, multicentre, parallel-group trial. Primary outcomes were remission and radiological changes at 2 years. All patients started with FIN-RACo. In addition, they were randomised to receive INFL or placebo (Pla) from weeks 4 to 26.ResultsAt 24 months, 66% and 53%, respectively, of the patients in the FIN-RACo+INFL and FIN-RACo+Pla groups were in remission according to the modified American College of Rheumatology (ACR) criteria (p=0.19), 26% and 10% were in sustained modified ACR remission (p=0.042) and 82% in both groups were in remission by 28-joint disease activity score (not significant). Mean changes in the total Sharp-van der Heijde score were 0.2 and 1.4, respectively (p=0.0058).ConclusionsMost patients with early active RA achieve clinical remission and develop negligible joint damage with the intensified FIN-RACo regimen. Adding INFL for the first 6 months delays radiological progression.

Objective. To assess the specificity and sensitivity of autoantibodies binding to citrullinated carboxyterminal telopeptides of types I and II collagens in an early arthritis series. Methods. A cohort of 146 patients from the Kuopio 2000 Arthritis Survey having RA, AS, PsA, ReA, uSpA or undifferentiated arthritis were studied. Autoantibodies binding citrullinated types I and II carboxytelopeptides were measured in two different inhibition ELISA assays. Sera from 135 adult persons were used as controls. Results. In RA, the sensitivities were 0.83 with long type I telopeptide and 0.78 with long type II telopeptide and the respective specificities were 0.94 and 0.93, while the corresponding values in other inflammatory joint diseases were much lower. The likelihood ratio in RA increased with longer peptides from 4.20 to 14.06 for type I telopeptide and from 2.74 to 11.67 for type II telopeptide. Conclusion. The antibody assay using long telopeptide from type I collagen was the most specific and sensitive method in every diagnostic category, although in the arthritides other than RA, binding was much less abundant and possibly citrulline-independent.

Biological therapy for ankylosing spondylitis (AS) has led to improved disease control beyond that of conventional treatments. International recommendations encourage clinicians prescribing biological treatments to register patients in national registers to collect information on outcome and toxicity. Patients with AS (n = 229) from the Register of Biological Treatment in Finland (ROB-FIN) with severe disease of long duration were followed-up for up to 24 months. Due to an active disease, one or more concomitant disease-modifying antirheumatic drugs (DMARDs) were used by 86% at commencement of biological therapy. This add-on strategy with infliximab led to a rapid pain relief and improvement of patient's and physician's global assessments, C-reactive protein/erythrocyte sedimentation rate, and swollen and tender joint counts within 6 weeks. Concomitant use of NSAID and oral corticosteroid was reduced. Corresponding results were documented at 3 months with etanercept, which was more recently approved for the treatment of spondyloarthropathies. Seventy-nine percent of the patients were ASAS 20 responders. A subgroup of AS patients with only axial involvement (n = 46) responded correspondingly. The first biological drug was discontinued in only 7% due to lack of efficacy and in 6% due to adverse events. Anti-TNF agents, often used in combination with DMARDs, appeared to have persistent effectiveness and limited toxicity in a real-life clinical setting in a cohort of Finnish AS patients with severe disease and long disease duration.

To assess the state of the disease and verify the diagnoses during a 7-24-month follow-up of adult patients with newly diagnosed inflammatory joint diseases in a defined population.Patients with previously undiagnosed synovitis in at least one peripheral joint or signs of inflammation in sacroiliac, glenohumeral or hip joints were enrolled on their first hospital visit in 2000 and followed-up for up to 24 months in Kuopio.A total of 138/173 adult patients completed a mean 13-month follow-up. During the follow-up the diagnosis was specified for 15/81 (19%) patients previously classified as undifferentiated arthritis (UA). Eight patients developed rheumatoid arthritis (RA). Of 28 patients with RA, 92% were on disease-modifying anti-rheumatic drugs (DMARDs) and 75% had a combination treatment with two or more DMARDs. According to the diagnosis at baseline, 75% of cases with RA, 38% with spondyloarthropathies (SpAs) and 42% with UA had active synovitis or arthralgia at follow-up. In multivariate analysis, older patients at disease onset were less likely to be in remission (p = 0.011).The diagnosis could be specified for 19% of patients with UA. Fifteen of 20 patients with RA had an active disease despite treatment with DMARDs. Patients with SpAs and UA had a better short-term outcome. Patients with active disease need aggressive therapy in all age groups.

Rheumatic diseases do not usually cluster in time and space. It has been proposed that environmental exposures may initiate autoimmune responses. We describe a cluster of rheumatic diseases among a group of health center employees who began to complain of symptoms typically related to moldy houses, including mucocutaneous symptoms, nausea and fatigue, within a year of moving into a new building. Dampness was found in the insulation space of the concrete floor below ground level. Microbes indicating mold damage and actinobacteria were found in the flooring material and in the outer wall insulation. The case histories of the personnel involved were examined. All 34 subjects working at the health center had at least some rheumatic complaints. Two fell ill with a typical rheumatoid factor (RF)-positive rheumatoid arthritis (RA), and 10 had arthritis that did not conform to any definite arthritic syndrome (three met the classification criteria for RA). Prior to moving into the problem building one subject had suffered reactive arthritis, which had then recurred. Another employee had undiagnosed ankylosing spondylitis and later developed psoriatic arthritis, and another developed undifferentiated vasculitis. A total of 16 subjects developed joint pains, 11 of these after beginning work at the health center. Three subjects developed Raynaud's symptom. Fourteen cases had elevated levels of circulating immune complexes in 1998, 17 in 1999, but there were only three cases in 2001, when the health center had been closed for 18 months. The high incidence of joint problems among these employees suggests a common triggering factor for most of the cases. As some of the symptoms had tended to subside while the health center was closed, the underlying causes are probably related to the building itself and possibly to the abnormal microbial growth in its structures.

Objective YKL-40, a chitinase-like glycoprotein associated with inflammation and tissue remodeling, is produced by joint tissues and recognized as a candidate auto-antigen in rheumatoid arthritis (RA). In the present study, we investigated YKL-40 as a potential biomarker of disease activity in patients with early RA at baseline and during intensive treatment aiming for early remission. Methods Ninety-nine patients with early DMARD-naive RA participated in the NEO-RACo study. For the first four weeks, the patients were treated with the combination of sulphasalazine, methotrexate, hydroxychloroquine and low dose prednisolone (FIN-RACo DMARD combination), and subsequently randomized to receive placebo or infliximab added on the treatment for further 22 weeks. Disease activity was evaluated using the 28-joint disease activity score and plasma YKL-40 concentrations were measured by immunoassay. Results At the baseline, plasma YKL-40 concentration was 57 +/- 37 ( mean +/- SD) ng/ml. YKL-40 was significantly associated with the disease activity score, interleukin-6 and erythrocyte sedimentation rate both at the baseline and during the 26 weeks' treatment. The csDMARD combination decreased YKL-40 levels already during the first four weeks of treatment, and there was no further reduction when the tumour necrosis factor-alpha antagonist infliximab was added on the combination treatment. Conclusions High YKL-40 levels were found to be associated with disease activity in early DMARD-naive RA and during intensive treat-to-target therapy. The present results suggest YKL-40 as a useful biomarker of disease activity in RA to be used to steer treatment towards remission.

Objective.With modern initial aggressive combination treatments with synthetic disease-modifying antirheumatic drugs (sDMARD), most patients with rheumatoid arthritis (RA) achieve remission, have marginal radiographic progression, and sustain normal function. Here we aim to identify the patients failing these targets even after aggressive treatment.Methods.Ninety-nine patients with early, active RA were treated with a combination of 3 sDMARD and prednisolone (PRD), and either infliximab or placebo infusions during the first 6 months, aiming at strict remission. After 24 months, the treatments became unrestricted. At 60 months, 4 evident clinical features of treatment failure were defined: area under curve (AUC) between 6–60 months for disease activity score assessing 28 joints > 2.6; AUC 6–60 for health assessment questionnaire > 0.5; progression in total Sharp/van der Heijde score 0–60 months > 3 units; and need of PRD or biologic DMARD treatment at 60 months.Results.A total of 93 patients were followed up for 60 months. Of them, 45 had no features of treatment failure, 30 had 1, 10 had 2, 7 had 3, and 1 patient had all 4 features. Having 2–4 features of treatment failure at 5 years was predicted by the health assessment score at baseline, and by even low residual disease activity at 3 and 6 months.Conclusions.Only 20% of the patients with RA treated early with combination sDMARD and PRD have more than 1 clinical feature of treatment failure at 60 months. Residual clinical disease activity at 3–6 months was the most important predictor for identifying these patients. The study was registered at www.clintrials.gov (NCT00908089).

Objective: To assess the intra-reader and inter-reader reliabilities of interpreting ultrasonography by several experts using video clips. Method: 99 video clips of healthy and rheumatic joints were recorded and delivered to 17 physician sonographers in two rounds. The intra-reader and inter-reader reliabilities of interpreting the ultrasound results were calculated using a dichotomous system (normal/abnormal) and a graded semiquantitative scoring system. Results: The video reading method worked well. 70% of the readers could classify at least 70% of the cases correctly as normal or abnormal. The distribution of readers answering correctly was wide. The most difficult joints to assess were the elbow, wrist, metacarpophalangeal (MCP) and knee joints. The intra-reader and inter-reader agreements on interpreting dynamic ultrasound images as normal or abnormal, as well as detecting and scoring a Doppler signal were moderate to good (κ = 0.52–0.82). Conclusions: Dynamic image assessment (video clips) can be used as an alternative method in ultrasonography reliability studies. The intra-reader and inter-reader reliabilities of ultrasonography in dynamic image reading are acceptable, but more definitions and training are needed to improve sonographic reproducibility.

Objective To evaluate the evolution of functional and clinical outcomes over 11 years in patients with early rheumatoid arthritis (RA) initially treated with a combination of 3 disease-modifying antirheumatic drugs (DMARDs) or with a single DMARD. Methods A cohort of 199 patients with early active RA were initially randomized to receive treatment with a combination of methotrexate, sulfasalazine, and hydroxychloroquine with prednisolone or treatment with a single DMARD (initially, sulfasalazine) with or without prednisolone. After 2 years, the drug treatment strategy became unrestricted, but still targeted remission. At 11 years, function was assessed with the Health Assessment Questionnaire (HAQ), and clinical outcomes were assessed with the modified Minimal Disease Activity (MDA) measure and the American College of Rheumatology (ACR) criteria for remission. Results At 11 years, 138 patients were assessed (68 in the combination-DMARD group and 70 in the single-DMARD group). The mean ± SD HAQ scores were 0.34 ± 0.54 in the combination-DMARD group and 0.38 ± 0.58 in the single-DMARD group (P = 0.88). Modified MDA was achieved by 63% (95% confidence interval [95% CI] 51, 77) and by 43% (95% CI 32, 55) (P = 0.016) of the combination-DMARD group and the single-DMARD group, respectively, and ACR remission by 37% (95% CI 26, 49) and by 19% (95% CI 11, 29) (P = 0.017), respectively. Conclusion Initial therapy with a combination of DMARDs in early RA results in higher rates of patients achieving modified MDA and strict ACR remission even over the long term than initial single-DMARD therapy. Targeting remission with tight clinical controls results in good functional and clinical outcomes in most RA patients.

To study the prevalence of different serotypes of Chlamydia trachomatis antibodies and the incidence of C. trachomatis-induced reactive arthritis (ReA) among patients with early arthritis in a defined population.Serum samples were collected from a cohort of 122 adult patients in the age group 18-65 years included in the Kuopio 2000 Arthritis Survey. Antibodies against C. trachomatis serotypes C, E, and G were studied using enzyme immunoassay (EIA) tests among patients and in a control cohort of 78 adults without any joint symptoms. The incidence assessment for Chlamydia-induced ReA was based on a ligase chain reaction (LCR) test in urine and clinical symptoms and signs appropriate for ReA.Of 122 patients, with the baseline diagnosis of rheumatoid arthritis (RA) in 11, spondyloarthropathy (SpA) in 28, and undifferentiated arthritis (UA) in 83 cases, 42 (34%) showed immunoglobulin (Ig)G or IgA antibodies against at least one serotype C, E, or G. Among the patients with UA the prevalence was significantly increased compared with the controls (p = 0.010). C. trachomatis-induced ReA arthritis was diagnosed in only three patients with the LCR test. On this basis the incidence of C. trachomatis-induced arthritis was 5.4/100 000 [95% confidence interval (CI) 1.1-15.7] in the age group 18-65 years.Antibodies against C. trachomatis were most common in patients with UA reflecting the fact that cases with chlamydia-induced ReA are included in this subgroup.

Background Intra-articular glucocorticoid injections are recommended for local treatment of synovitis regardless of the disease severity or the concurrent therapy [1]. However, the accurate placement of the puncture is challenging and if not succeeded it may impair clinical outcome or even lead to complications. The accuracy rate of non-guided injections varies around 30% - 80% [2, 3] which emphasizes the need for needle guidance. In addition to established methods (e.g. ultrasound), electrical tissue properties can be utilized for needle guidance [4]. Objectives This study introduces a new real-time needle guidance method which utilizes bioimpedance spectroscopy (BIS) with standard 22G and 24G needles. In this exploratory clinical study the system parameters are tuned and performance tested. Methods The measurement system (Injeq Ltd) consisted of a conventional injection needle together with a bioimpedance probe (BIP) stylet connected to the measurement device (as shown in Figure). It performs bipolar BIS between the electrode at the tip of the stylet and the surrounding needle. Based on the BIS results, system classifies the tissue using mathematical model in real-time and beeps when synovial fluid is detected. Parameter tuning was performed during studies based on offline analysis. In this phase, 23 patients suffering from arthritis were injected to 31 joints by experienced rheumatologists. Success of the injection was verified by aspiration of synovial fluid, absence of resistance during injection and/or using ultrasound imaging for locating the needle. Results The electrical properties of human synovial fluid differ significantly from surrounding tissues. Small and inflamed joints do not appear to contain pure well conducting synovial fluid, but they are still distinguishable from the surrounding tissues. This kind of new class, termed Complex, was included to the model after 10 injections. After the inclusion, the device correctly detected either Complex or Pure synovial fluid in 18 out of 21 injections. One joint was dry and device provided true negative result. Remaining two injections were false negative. Conclusions BIP needle is a new, easy to use method for assisting placement of the needle during intra-articular injection. In this exploratory phase, synovial fluid detection functioned properly in 19/21 cases. Thus, BIP showed ability to provide needle guidance and the study will be continued to statistically significant phase. References Beukelman T et al. 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: initiation and safety monitoring of therapeutic agents for the treatment of arthritis and systemic features. Arthritis Care & Research 63.4 (2011): 465-482. Balint PV et al. Ultrasound guided versus conventional joint and soft tissue fluid aspiration in rheumatology practice: a pilot study. J. Rheumatol. 29.10 (2002): 2209-2213. Pichler W et al. Frequency of successful intra-articular puncture of finger joints: influence of puncture position and physician experience. Rheumatology 47.10 (2008): 1503-1505. Kalvoy H et al. Impedance-based tissue discrimination for needle guidance. Physiological measurement 30.2 (2009): 129-140. Disclosure of Interest P. Parmanne: None declared, E. Kankaanpaa: None declared, S. Maki Employee of: Injeq, J. Kari Employee of: Injeq, H. Relas: None declared, R. Tuompo: None declared, R. Peltomaa: None declared, K. Kronstrom Shareholder of: Injeq, Employee of: Injeq, R. Luosujarvi: None declared

The aim of this study was to evaluate the effectiveness of IL-1 inhibition in rheumatic disease using real-life, observational methods. We analyzed data from 47 patients collected from the national ROB-FIN for rheumatic disease. Commonly used, validated measures of efficacy and adverse effects were documented and analyzed. The series contains 47/1,135 patients (mean age 47+/-11 years, range 25-73, females 83%) on anakinra of whom 39 patients suffered from rheumatoid arthritis (RA), two presented with psoriatic arthritis, and four with juvenile RA. At 3 months (26/40), 46% reached American College of Rheumatology (ACR) 20 and 27% ACR 50. In patients naive to biological drugs, the response rate at 3 months was 60% for ACR 20 and 20% for ACR 50. At follow-up of the total series, ACR responses at 6 and 12 months were 69/56% for ACR 20 and 23/22% for ACR 50. These data give room for IL-1 suppression when treating patient with rheumatic disease. Careful selection of patients, together with combining anakinra with disease-modifying antirheumatic drugs, perhaps adds effectiveness. For treating clinicians in Finland, these results are encouraging, as reimbursed treatment alternatives for patients refractory to all other therapies are still few.

Background Resistin is an adipocytokine related to insulin resistance, inflammation and arthritis (1). Objectives We investigated if resistin is associated with the disease activity and inflammation in DMARD-naive rheumatoid arthritis (RA) patients, if it possesses predictive value on the disease progression, and if TNFα is involved in these effects. Methods Ninety patients with early, DMARD-naive RA participated in the NEO-RACo study. The patients were treated for the first four weeks with a combination of methotrexate (max 25 mg/week), sulfasalazine (max 2 g/day), hydroxychloroquine (35 mg/kg/week), and prednisolone (7.5 mg/day) (FIN-RACo treatment strategy). Thereafter patients were randomized to receive either infliximab or placebo added on the combination therapy and infusions were given at weeks 4, 6, 10, 18 and 26. Patients were followed for 5 years. Human macrophage cell-line THP-1 was used to study the effects of resistin on TNFα production in the in vitro studies. Results At baseline, resistin levels correlated with disease activity and inflammation measured as DAS28 and ESR: when the patients were divided in tertiles based on their plasma resistin levels at baseline, DAS score showed positive linearity (p for linearity =0.0072) and similarly, ESR levels increased linearly in resistin tertiles (p for linearity The predictive value of baseline resistin was evaluated on the disease progression during the 5 years follow-up. Highest resistin predicted more rapid radiological progression in the FIN-RACo + placebo group as measured by change in Sharp-van der Heijde total score (Fig. 1A). However, the baseline resistin level was not predictive in relation to the remission rate. Interestingly, adding infliximab to the treatment delayed the radiological progression and there was no difference in the radiological progression in the FIN-RACo + infliximab group between the resistin tertiles (Fig. 1B). Resistin also increased TNFα production THP-1 macrophages in vitro. Conclusions High resistin level at the baseline was linked to active inflammatory disease and predicted erosive disease progression. Further, resistin increased the production of TNFα in macrophages in the in vitro studies and infliximab treatment overcame the poor predictive value of high resistin levels in the NEO-RACo study suggesting that the effects of resistin are mediated by TNFα. High resistin concentration may be a useful marker to distinguish patients with risk for erosive disease, who respond better to treatment with a combination of DMARDs and TNFα-antagonists rather than with traditional DMARDs only. References M. Scotece, J. Conde, K. Vuolteenaho, A. Koskinen, V. Lόpez, J. Gόmez-Reino, F. Lago, E. Moilanen, O. Gualillo. Adipokines as drug targets in joint and bone disease. Drug Discov Today, in press 2014. Acknowledgements The participating patients, research personnel and other members of NEO-RACo Study Group are greatly acknowledged. Disclosure of Interest K. Vuolteenaho Consultant for: *, H. Kautiainen Consultant for: *, T. Mottonen Consultant for: *, P. Hannonen Consultant for: *, M. Korpela Consultant for: *, M. Kauppi Consultant for: *, O. Kaipiainen-Seppanen Consultant for: *, R. Luosujarvi Consultant for: *, R. Nieminen Consultant for: *, M. Leirisalo-Repo Consultant for: *, E. Moilanen Consultant for: *All authors have received consulting fees or honoraria from all or some of the following: Abbott, Actelion, Amgen, Astra-Zeneca, BMS, Ely Lilly, GSK, MSD, Mundipharma, Pfizer, Roche, Schering-Plough, Servier, UCB Pharma. DOI 10.1136/annrheumdis-2014-eular.1680

Background Given the existing evidence that the degree of response to certolizumab pegol (CZP) at Week 12 is determinant of the probability of long-term response to CZP, a risk-sharing scheme (RSS) was created and embedded in a clinical decision rationale. It also aligns with recent European treatment guidelines, emphasizing a treat-to-target approach in rheumatoid arthritis (RA) with an intensive monitoring of patients and rapid, pro-active switching in case of non-response. Objectives Assessment of an RSS for CZP in terms of treatment response, per-patient value-for-money and affordability in the Finnish population. Methods To evaluate the effects and costs (administration, drug, in-patient, monitoring, adverse events, travelling, productivity; 2011 real value) of biologic treatments for RA in anti-TNF-naive patients, a literature search of American College of Rheumatology (ACR) ACR70, ACR50 and ACR20 outcomes at weeks 12 and 24, and Bayesian network meta-analyses were carried out. Per-patient cost-effectiveness and per-population budget impact were assessed in a new, hybrid stochastic Markov model, combining cost-effectiveness and budget impact analyses. Using 12-week cycles, multiple comparators (so-called treatment-mix modelling, ie. in proportion to their current market share in Finland) and a Finnish societal perspective that includes direct and indirect costs, anti-TNF therapies were compared over a 5-year horizon. If an ACR20 response was achieved at Week 12, CZP treatment was continued. Otherwise, CZP acquisition costs were refunded under a proposed RSS, and alternative treatment was initiated. Quality-adjusted life-years were estimated based on a relationship between EQ-5D and Health Assessment Questionnaire. The budget impact part assumes a rising incidence of RA during 2013–2017 in Finland and includes treatment persistence estimates. Results The meta-analysis showed that 72.4% (95% confidence interval 64.7–80.3%) of CZP-treated patients had an ACR20 response at Week 12, compared to estimated ACR20 response at Week 12 of 60.2% with adalimumab, 52.5% with etanercept, and 55.5% with golimumab. Over the 5 years, introducing the CZP RSS for all new patients provided cost savings per patient of €4,796 together with 0.04 additional quality-adjusted life-years (with 100% cost-effectiveness probability). If using an RSS, approximately 4.7% of CZP acquisition costs would be refunded. The correspondent budget per patient-year was estimated at €27,310 under the current mix of anti-TNFs and subsequent therapies, which could be reduced to average €26,178 per patient-year if all starting patients were to receive CZP with RSS. Whereas the magnitude of the budget impact varied according to different assumptions, all the sensitivity analyses conducted were consistent and showed that CZP would reduce costs and improve patient health. Conclusions The current analysis showed that CZP is effective and cost-effective compared to the current mix of treatments in Finland. An outcomes-based RSS would increase affordability even further. Acknowledgements The authors acknowledge Costello Medical Consulting for editorial assistance which was funded by UCB Pharma. Disclosure of Interest C. Asseburg Employee of: ESiOR Oy, E. Soini Shareholder of: ESiOR Oy, Grant/research support from: ISPOR, Kauneuskeskus Mona Oy, University of Eastern Finland, Consultant for: Kauneuskeskus Mona Oy, Employee of: ESiOR Oy, Paid instructor for: Kauneuskeskus Mona Oy, Speakers bureau: University of Eastern Finland, Kuopio University Hospital, K. Puolakka Consultant for: Pfizer, MSD, UCB Pharma, O. Purcaru Employee of: UCB Pharma, M. Taiha Employee of: UCB Pharma, R. Luosujarvi Speakers bureau: BMS, Abbott, Pfizer, RiLu