S. Ramiro

European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update

Background Since the publication of the European League Against Rheumatism recommendations for the pharmacological treatment of psoriatic arthritis (PsA) in 2012, new evidence and new therapeutic agents have emerged. The objective was to update these recommendations. Methods A systematic literature review was performed regarding pharmacological treatment in PsA. Subsequently, recommendations were formulated based on the evidence and the expert opinion of the 34 Task Force members. Levels of evidence and strengths of recommendations were allocated. Results The updated recommendations comprise 5 overarching principles and 10 recommendations, covering pharmacological therapies for PsA from non-steroidal anti-inflammatory drugs (NSAIDs), to conventional synthetic (csDMARD) and biological (bDMARD) disease-modifying antirheumatic drugs, whatever their mode of action, taking articular and extra-articular manifestations of PsA into account, but focusing on musculoskeletal involvement. The overarching principles address the need for shared decision-making and treatment objectives. The recommendations address csDMARDs as an initial therapy after failure of NSAIDs and local therapy for active disease, followed, if necessary, by a bDMARD or a targeted synthetic DMARD (tsDMARD). The first bDMARD would usually be a tumour necrosis factor (TNF) inhibitor. bDMARDs targeting interleukin (IL)12/23 (ustekinumab) or IL-17 pathways (secukinumab) may be used in patients for whom TNF inhibitors are inappropriate and a tsDMARD such as a phosphodiesterase 4-inhibitor (apremilast) if bDMARDs are inappropriate. If the first bDMARD strategy fails, any other bDMARD or tsDMARD may be used. Conclusions These recommendations provide stakeholders with an updated consensus on the pharmacological treatment of PsA and strategies to reach optimal outcomes in PsA, based on a combination of evidence and expert opinion.

Pharmacological treatment of psoriatic arthritis: a systematic literature review for the 2015 update of the EULAR recommendations for the management of psoriatic arthritis

Objective To update the evidence on the efficacy and safety of pharmacological agents in psoriatic arthritis (PsA). Methods Systematic literature review of randomised controlled trials comparing pharmacological interventions in PsA: non-steroidal anti-inflammatory drugs, glucocorticoid, synthetic disease modifying antirheumatic drugs (sDMARDs) either conventional or targeted, biologicals (bDMARDs), placebo or any combination. Main outcomes were American College of Rheumatology (ACR)20–50, Psoriasis Area Severity Index 75, radiographic progression, and withdrawals due to adverse events (AEs). Multiple studies of the same intervention were meta-analysed using random effects. Results In total, 25 papers and 12 abstracts were included. The efficacy of tumour necrosis factor inhibitors (including the recently added golimumab and certolizumab pegol) was confirmed and 16 articles/abstracts focused on 3 drugs with new modes of action: ustekinumab (UST), secukinumab (SEC) and apremilast (APR). All were placebo-compared trials and met their primary end point, ACR20. In 2 studies with UST ACR20 was met by 50% and 44% of patients with UST 90 mg, 42% and 44% with UST 45 mg vs 23% and 20% with placebo, respectively. In two studies with SEC ACR20 ranged 54% (SEC 300 mg), 50–51% (SEC 150 mg), 29–51% (SEC 75 mg) and 15–17% (placebo). In four studies with APR, ACR20 ranged 32–43% (APR 30 mg), 29–38% (APR 20 mg) and 17–20% (placebo). For all three drugs, no more withdrawals due to AEs than placebo were seen and, in general, safety appeared satisfactory. A strategy trial, TIght COntrol of Psoriatic Arthritis (TICOPA), showed better ACR responses with treatment adaptations upon tight control compared with standard care. Conclusions UST, SEC and APR are new drugs with efficacy demonstrated for the treatment of PsA. No major safety signals arise, but long-term studies are needed. This review informed about the European League Against Rheumatism recommendations for management of PsA.

Ultrasound cut-off values for intima-media thickness of temporal, facial and axillary arteries in giant cell arteritis

Objective To evaluate the intima-media thickness (IMT) of arteries involved in GCA for determining cut-off values. Methods Forty newly diagnosed GCA patients in a fast-track GCA clinic and 40 age- and sex-matched controls were included. IMT measurement was performed at or within 24 h after diagnosis. The common superficial temporal arteries with their frontal and parietal branches and the facial arteries were bilaterally examined with a 10-22 MHz probe and the axillary artery with a 6-18 MHz probe. Receiver operating characteristics analysis was performed for estimating cut-off values. Results The mean age was 72 years (s.d. 9) and 68% were females. In the control group, IMT was 0.23 mm (s.d. 0.04), 0.19 mm (s.d. 0.03), 0.20 mm (s.d. 0.03), 0.24 mm (s.d. 0.05) and 0.59 mm (s.d. 0.10) for the common superficial temporal arteries, the frontal and parietal branches, the facial arteries and the axillary arteries, respectively. In vasculitic segments of GCA patients, IMT was 0.65 mm (s.d. 0.18), 0.54 mm (s.d. 0.18), 0.50 mm (s.d. 0.17), 0.53 mm (s.d. 0.16) and 1.7 mm (s.d. 0.41), respectively. Cut-off values are 0.42, 0.34, 0.29, 0.37 and 1.0 mm, respectively, with 100% sensitivities and specificities for common superficial temporal arteries, for frontal branches and for axillary arteries and sensitivities of 97.2 and 87.5% and specificities of 98.7 and 98.8% for parietal branches and facial arteries, respectively. The intraclass correlation coefficient was between 0.87 and 0.98. Conclusion IMT measurement can correctly distinguish vasculitic from normal arteries in suspected GCA.

Work Outcome in Patients With Ankylosing Spondylitis: Results From a 12‐Year Followup of an International Study

To understand the impact of ankylosing spondylitis (AS) on work disability (WD) over 12 years compared with the general population, and explore factors predicting adverse work outcome, defined as new partial WD or reduction in working hours.

FRI0082 In Addition to Individual Demographic and Clinical Measures, Levels of Fatigue Are Dependent on Country of Residence. An Analysis among 3920 Patients from 17 Countries (The Comora Study)

Background For patients with rheumatoid arthritis (RA), fatigue is an important aspect of disease which impacts quality of life. However the complex relationship between fatigue and either disease-related or external factors remains unclear. Country of residence as a surrogate for a variety of cultural, economic, climatological and linguistic aspects might play a role, but this has never been formally explored. Objectives To investigate how country of residence influences level of fatigue in addition to socio-demographic and objective disease- characteristics. Methods Data from a multi-national study were used (COMORA). Fatigue was measured using 0-10 VAS scale. A multivariable linear regression model (outcome fatigue) was computed using manual forward selection. Contribution of socio-demographic factors (age, gender, education, marital status, work status), comorbidities (Wolfe-Michaud index), smoking status, clinical disease characteristics (tender and swollen joints (TJC, SJC), erosions in hands or feet (yes/no), erythrocyte sedimentation rate) and medication (all type of DMARDs, steroids and NSAIDs) was tested. Country of residence was added using the country with the highest level of fatigue (Netherlands) as reference. In a second step, sensitivity analyses were developed replacing country of residence by country specific variables including gross domestic product (GPD), human development index (HDI), a climate indicator (latitude) and income inequality (gini index). Results 3920 patients from 17 countries (range: 30 to 411, mean age 56 years (SD 13), 82% female). Mean fatigue across countries was 4.13 (SD 2.8). 32.8% of all patients had fatigue scores >5. In multi-variable regression, female gender (βf=1=0.72, CI 0.50/0.93) and a higher comorbidity score (β=0.30, CI 0.24/0.37) were associated with higher fatigue. TJC and SJC had limited influence on fatigue with higher contribution of TJC (βTJC=0.14, CI 0.12/0.16 and βSJC=0.05, CI 0.25/0.79). When adding country, the contribution was significant and increased the overall model fit (Δ R2=0.07). Country differences in fatigue varied between -3.9 for Venezuela vs Netherlands (NL) and -0.6 (Italy vs NL) after adjustment for individual factors. When country was replaced by GDP, HDI, latitude or gini index, only GPD and HDI index contributed significantly. The overall model improvement was lower compared to country (R2 GDP=0.14, R2 HDI=0.18, R2 country=0.20). Interactions were not significant. Conclusions While individual demographics and objective clinical measures of disease have only a small influence on the experience of fatigue, the country of residence adds substantially. Economic and development status of the country only explain small parts of the variation among countries. More research is needed to identify other relevant cultural (attitudes, believes), climatological or linguistic aspects that could explaining fatigue. Disclosure of Interest M. Hifinger Employee of: Hexal AG, Germany (inactive employment, maternity leave), P. Putrik: None declared, S. Ramiro: None declared, A. Keszei: None declared, I. Hmamouchi: None declared, M. Dougados: None declared, L. Gossec: None declared, A. Boonen: None declared DOI 10.1136/annrheumdis-2014-eular.2098

Socioeconomic inequities in perceived health among patients with musculoskeletal disorders compared with other chronic disorders: results from a cross-sectional Dutch study.

Objectives To explore the impact of socioeconomic factors on physical and mental health of patients with musculoskeletal disorders (MSKDs) and compare it across patients with other disorders. Methods A representative sample of the Dutch population (n=8904) completed a survey on sociodemographics, physician-diagnosed (co-) morbidities, and physical (physical component summary, PCS) and mental (mental component summary, MCS) subscales of SF-12 (outcome variables). Regression models were computed first in the total group of patients with MSKDs, with education, age, gender, origin and place of residence as independent variables, and, second, in individuals expected to have paid work, adding a variable on social status. Models were repeated for five other subgroups of chronic disorders (cardiovascular (CVD), diabetes, cancer, mental and respiratory) and for healthy individuals. Results MSKDs confirmed by a physician were reported by 1766 (20%) participants (mean age 59 years, 38% male), 547 (6%) respondents reported to have diabetes, 1855 (21%) CVD, 270 (3%) cancer, 526 (6%) mental disorders, 679 (8%) respiratory disorders and 4525 (51%) did not report any disease. In patients with MSKDs, (primary school vs university education (−5.3 (PCS) and −3.3 (MCS)) and having a state subsidy vs paid work (−5.3 (PCS) and −4.7 (MCS)) were consistently associated with worse physical and mental health. Gender was only relevant for PCS (female vs male −2.1). Comparable differences in health by education and social status were observed in the other diseases, except for cancer. Conclusions Education and social status in MSKD have the same strong and independent association with health as in other chronic diseases. These health gradients are unfair and partly avoidable, and require consorted attention and action in and outside healthcare.

New GRAPPA and EULAR recommendations for the management of psoriatic arthritis: Process and challenges faced.

In 2015, both the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and the EULAR presented updated recommendations on the management of PsA [1, 2]. New therapies, assessments and increasing evidence on comorbidities required substantial revision of treatment strategies. This editorial provides comments on the key barriers faced and how these were addressed. The challenges focus around the remit of the recommendations, the scope of the literature review and assessment of the available data.

Definitions and reliability assessment of elementary ultrasound lesions in giant cell arteritis: a study from the OMERACT Large Vessel Vasculitis Ultrasound Working Group

Objectives To define the elementary ultrasound (US) lesions in giant cell arteritis (GCA) and to evaluate the reliability of the assessment of US lesions according to these definitions in a web-based reliability exercise. Methods Potential definitions of normal and abnormal US findings of temporal and extracranial large arteries were retrieved by a systematic literature review. As a subsequent step, a structured Delphi exercise was conducted involving an expert panel of the Outcome Measures in Rheumatology (OMERACT) US Large Vessel Vasculitis Group to agree definitions of normal US appearance and key elementary US lesions of vasculitis of temporal and extracranial large arteries. The reliability of these definitions on normal and abnormal blood vessels was tested on 150 still images and videos in a web-based reliability exercise. Results Twenty-four experts participated in both Delphi rounds. From originally 25 statements, nine definitions were obtained for normal appearance, vasculitis and arteriosclerosis of cranial and extracranial vessels. The ‘halo’ and ‘compression’ signs were the key US lesions in GCA. The reliability of the definitions for normal temporal and axillary arteries, the ‘halo’ sign and the ‘compression’ sign was excellent with inter-rater agreements of 91–99% and mean kappa values of 0.83–0.98 for both inter-rater and intra-rater reliabilities of all 25 experts. Conclusions The ‘halo’ and the ‘compression’ signs are regarded as the most important US abnormalities for GCA. The inter-rater and intra-rater agreement of the new OMERACT definitions for US lesions in GCA was excellent.

Is site of back pain related to location of MRI lesion in patients with chronic back pain included in the SPACE-cohort?

To determine associations between magnetic resonance imaging (MRI) lesions originating from either axial spondyloarthritis (SpA) or from degeneration and pain in patients with chronic back pain of <2 years duration.

Work outcome in patients with ankylosing spondylitis: results of 12-year follow-up in OASIS

To understand the impact of ankylosing spondylitis (AS) on work disability (WD) over 12 years compared with the general population, and explore factors predicting adverse work outcome, defined as new partial WD or reduction in working hours.