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BackgroundIn inflammatory bowel disease (IBD), a new biological therapy has recently been approved. Vedolizumab is a humanised IgG1 monoclonal antibody to α4β7 integrin that modulates gut lymphocyte trafficking. Although an exclusively local effect of vedolizumab could be expected based on the restricted presence of the α4β7–mucosal vascular addressin cell adhesion molecule 1 complex in the gut, past combined success with anti-tumour necrosis factor, and previous demonstration of α4β7 integrin in the joint, led to the expectation of a therapeutic efficacy in spondyloarthritis. Nonetheless, the effect of vedolizumab on extraintestinal manifestations—and especially the joint—has not been reported so far.Case reportA series of five patients with IBD who were treated with vedolizumab and promptly developed new onset or exacerbation of sacroiliitis or arthritis are reported.ConclusionsVedolizumab therapy does not seem to show any efficacy in and might even induce arthritis and/or sacroiliitis. However, larger cohort studies are needed to provide information on the prevalence, the evolution and underlying mechanism.

ObjectivesTo compare the efficacy and safety of intensive combination strategies with glucocorticoids (GCs) in the first 16 weeks (W) of early rheumatoid arthritis (eRA) treatment, focusing on high-risk patients, in the Care in early RA trial.Methods400 disease-modifying antirheumatic drugs (DMARD)-naive patients with eRA were recruited and stratified into high risk or low risk according to classical prognostic markers. High-risk patients (n=290) were randomised to 1/3 treatment strategies: combination therapy for early rheumatoid arthritis (COBRA) Classic (methotrexate (MTX)+ sulfasalazine+60 mg prednisone tapered to 7.5 mg daily from W7), COBRA Slim (MTX+30 mg prednisone tapered to 5 mg from W6) and COBRA Avant-Garde (MTX+leflunomide+30 mg prednisone tapered to 5 mg from W6). Treatment modifications to target low-disease activity were mandatory from W8, if desirable and feasible according to the rheumatologist. The primary outcome was remission (28 joint disease activity score calculated with C-reactive protein ResultsData from 98 Classic, 98 Slim and 94 Avant-Garde patients were analysed. At W16, remission was reached in 70.4% Classic, 73.6% Slim and 68.1% Avant-Garde patients (p=0.713). Likewise, no significant differences were shown in other secondary endpoints. However, therapy-related AEs were reported in 61.2% of Classic, in 46.9% of Slim and in 69.1% of Avant-Garde patients (p=0.006).ConclusionsFor high-risk eRA, MTX associated with a moderate step-down dose of GCs was as effective in inducing remission at W16 as DMARD combination therapies with moderate or high step-down GC doses and it showed a more favourable short-term safety profile.EudraCT number:2008-007225-39.

Background Psoriatic arthritis (PsA) is a common form of chronic arthritis strongly associated with the skin disease psoriasis. The gender distribution is considered equal but it is suggested that their might be gender related differences in disease expression, disease activity and outcome. The BEPAS cohort (Belgian Epidemiological Psoriatic Arthritis Study) is a large prospective multicenter real life cohort set up in 17 Belgian large academic and non academic rheumatology practices that offers a unique opportunity to study the disease patterns with their respective articular and skin involvement in this patient group Objectives (1) To assess gender-related differences in disease patterns and articular manifestations of psoriatic arthritis Methods A cross-sectional analysis at the inclusion visit was performed among the male and female patients included in the BEPAS cohort. They were evaluated for the demographics, the disease patterns at diagnosis and the presence of clinical articular and extra–articular manifestations at inclusion. Gender differences were evaluated by one way ANOVA or Chi –square testing. Results 461 patients including 263 male patients and 198 female patients with mean age: 52.79 years (±12.29) were recruited in the 17 centers from December 2012 to July 2014.There was no gender difference in rheumatoid factor, anti–CCP and extra-articular manifestations such as uveitis and inflammatory bowel disease Conclusions The disease patterns and clinical manifestations differ in several aspects between male and female PsA. They have a different clinical articular presentation at diagnosis: male patients have more polyarticular disease while female patients have more entheseal disease. Skin involvement is comparable except for male patients having more nail involvement. These differences might have impact on the disease evolution, severity and treatment decisions. Disclosure of Interest K. De Vlam: None declared, R. Lories Grant/research support from: MSD Belgium, S. Steinfeld Grant/research support from: MSD Belgium, F. Van Den Bosch Grant/research support from: MSD Belgium, A. Nzeusseu Toukap Grant/research support from: MSD Belgium, M. Malaise Grant/research support from: MSD Belgium, V. Taelman Grant/research support from: MSD Belgium, F. Van Bruwaene Grant/research support from: MSD Belgium, M. Van Den Berghe Grant/research support from: MSD Belgium, J. Lenaerts Grant/research support from: MSD Belgium, R. Joos Grant/research support from: MSD Belgium, P. Geusens Grant/research support from: MSD Belgium, S. Dall9Armellina Grant/research support from: MSD Belgium, I. Peene Grant/research support from: MSD Belgium, G. De Brabanter Grant/research support from: MSD Belgium, M. Van Den Berghe Grant/research support from: MSD Belgium, J. QU Grant/research support from: MSD Belgium, M. Maertens Grant/research support from: MSD Belgium, H. Leroi Employee of: MSD Belgium

Background Psoriatic Arthritis is often considered to be predominantly peripheral presenting with arthritis, dactylitis and enthesitis. Consequently randomized controlled trials, screening procedures for early detection and treatment strategies largely focus on peripheral disease. Axial involvement is considered less common. The BEPAS cohort (Belgian Epidemiological Psoriatic Arthritis Study) is a prospective multicenter real life cohort set up in 17 Belgian large academic and non academic rheumatology practices that offers a unique opportunity to study the axial involvement in this patient group. Objectives (1) To estimate the prevalence of axial involvement in patients with PsA in general (2) to estimate the prevalence of inflammatory back pain in patients with PsA; (3) to estimate the influence of disease duration on spinal manifestations. Methods Patients included in the BEPAS cohort were evaluated for the presence of a clinical phenotype indicating axial involvement, the specific presence of spinal complaints (reported by patients) and the presence of inflammatory back pain according the Rudwaleit criteria. Demographics and clinical features were recorded. BASDAI and BASMI were calculated. Results Among the 461 recruited patients (mean age: 52.79 years (±12.29), male 57%) 157 patients (34,1%) fulfilled the Berlin Criteria for inflammatory back pain with a higher prevalence in female patients (40,5% vs 28,9%, p=0.007) at inclusion.A family history of ankylosing spondylitis is reported in 3.3% of the patients. Clinical characteristics and demographics are listed in table 1. Conclusions The BEPAS cohort reports a substantial contribution of inflammatory axial involvement to the clinical and inflammatory burden of disease in PsA patients. Inflammatory axial involvement is a common clinical phenotype in PsA patients reporting higher disease activity and worse health status occurring more frequent in female patients, contrasting with other spondyoloartropathies. Disclosure of Interest K. De Vlam: None declared, R. Lories Grant/research support from: MSD Belgium, S. Steinfeld Grant/research support from: MSD Belgium, F. Van Den Bosch Grant/research support from: MSD Belgium, A. Nzeusseu Toukap Grant/research support from: MSD Belgium, M. Malaise Grant/research support from: MSD Belgium, V. Taelman Grant/research support from: MSD Belgium, F. Van Bruwaene Grant/research support from: MSD Belgium, M. Van Den Berghe Grant/research support from: MSD Belgium, J. Lenaerts Grant/research support from: MSD Belgium, R. Joos Grant/research support from: MSD Belgium, P. Geusens Grant/research support from: MSD Belgium, S. Dall9Armellina Grant/research support from: MSD Belgium, I. Peene Grant/research support from: MSD Belgium, G. De Brabanter Grant/research support from: MSD Belgium, M. Van Den Berghe Grant/research support from: MSD Belgium, J. QU Grant/research support from: MSD Belgium, M. Maertens Grant/research support from: MSD Belgium, H. Leroi Employee of: MSD Belgium

Avontuurlijke, sportieve reizen zitten in de lift, maar zij vormen een belasting voor niet-getrainde spieren, pezen en gewrichten. Men moet bij de planning dus goed het karakter van de reis bekijken. Worden er speciale eisen aan het bewegingsapparaat gesteld? Is de algemene conditie goed? Het transport zelf verloopt niet altijd zonder moeilijkheden en kan gepaard gaan met een periode van immobilisatie.

Background To date, intensive DMARD combination therapy with glucocorticoids (GCs) is the most effective treatment approach for the management of early Rheumatoid Arthritis (eRA). The ideal content of the combination and the dose of GCs are however not yet known. Objectives To compare different intensive combination treatment strategies associated with GCs in eRA patients with a poor prognosis at week (W)52 in the CareRA trial. Methods CareRA is a two year prospective investigator-initiated multicenter RCT rooted in daily practice. DMARD naive eRA patients were stratified into a high or low-risk group based on classical prognostic markers (presence of erosions, rheumatoid factor, anti-cyclic citrullinated protein and DAS28(CRP). High-risk patients (n=290) were randomized to 1 of 3 treatment strategies. 1) Cobra Classic (n=98): Methotrexate (MTX)+Sulphasalazine+60mg prednisone tapered weekly to 7.5mg daily from W7 2) Cobra Slim (n=98): MTX+30mg prednisone tapered to 5 mg daily from W6 3) Cobra Avant-Garde (n=94):MTX+Leflunomide +30mg prednisone tapered to 5 mg daily from W6 From W28, GCs were tapered in all patients and stopped at W34. A predefined treat to target approach was applied. From W40, we aimed for DMARD monotherapy. Efficacy measures were proportions of DAS28(CRP) remission, good EULAR response, clinically meaningful HAQ response, HAQ=0 (ITT analysis). Radiographic progression was measured via the Sharp Van der Heijde score. Adverse events related to therapy (AEs) were registered. Missing data were imputed by last observation carried forward. Results Remission rates were 64.3%, 60.2% and 62.8% in the Classic, Slim and Avant-Garde group respectively (p=0.837). Also no other efficacy outcomes did not differ between groups. 82% of X-ray images were available at baseline. Radiographic progression was minimal. SvH scores were 1.3±2.1, 1.3±2.5 and 1.0±1.4 at baseline and changed over 52 weeks 0.3±0.5, 0.4±1.1 and 0.3±0.6 in the Classic, Slim and Avant-Garde group respectively (p=0.581). The total numbers of AEs were 182 in 65 Classic patients, 125 in 64 Slim patients and 174 in 72 Avant-Garde patients (p=0.026). Serious AEs were reported in 3 Classic, 2 Slim and 3 Avant-Garde patients. Conclusions High rates of remission were achieved at week 52 with csDMARDs and GCs in all remission induction schemes. Cobra Slim showed comparable efficacy with less adverse events compared to DMARD combinations with moderate or high GC dosages. Disclosure of Interest None declared

Background Psoriatic arthritis is a chronic arthritis with major impact on the physical and psychosocial integrity of the patient. Only few prospective data are available. BEPAS (Belgian Epidemiological Psoriatic Arthritis Study) is a large prospective multicenter cohort set up in 17 Belgian rheumatology practices. Objectives (1) to generate a comprehensive database in order to characterize the clinical presentation and the frequency of the distinct PsA subtypes; (2) to estimate the severity of disease based on disease activity scores, active inflammation and structural damage; (3) to estimate the impact in terms of health-related quality of life of PsA in Belgium and (4) to evaluate progression of structural damage in patients with PsA over time. Methods Patients with an existing or a new clinical diagnosis of PsA and fulfilling the CASPAR classification criteria were recruited.A specific selection rule was applied to avoid selection bias. All patients gave informed consent. Recruitment of the patients occurred in 17 large rheumatology centers across Belgium. In the prospective study, patients are followed every year during the first 2 years with a possible extension for an additional 5 years. Demographics and clinical parameters, and additional information about QoL and disability were collected. X-rays of hands and feet are performed every year and axial X-rays every 2 years. Results 461 patients (mean age: 52.79 years (±12.29), male 57%) were recruited in the 17 centers from december 2012 to July 2014. Average time between first complaints and diagnosis of PsA was 8.6 yrs (±9.3), 27.5% of the patients had a disease duration of less than 2 years. Combined peripheral and axial involvement was reported in 73.7% of the patients, only peripheral involvement in 25,4% and only axial involvement in 0.7% of the patients. At entry polyarticular, oligoarticular and monoarticular joint involvement was reported in respectively 25.8%, 12.2% and 8.9% of the patients. Dactylitis and enthesitis were reported in respectively 11.3% and 14% at entry. Psoriasis type1 (onset Conclusions This large cohort paints a real-life heterogeneous presentation of PsA in Belgium. Further data collection and analysis should facilitate clinical and outcome studies in order to improve our knowledge on the impact and natural history of PsA in Belgium. Acknowledgements This study was sponsored by MSD Disclosure of Interest K. de Vlam Grant/research support from: MSD, R. Lories: None declared, S. Steinfeld: None declared, F. Van Den Bosch: None declared, A. Nzeusseu Toukap: None declared, M. Malaise: None declared, V. Taelman: None declared, F. Van Bruwaene: None declared, M. Vanden Berghe: None declared, R. Joos: None declared, J. Lenaerts: None declared, P. Geussens: None declared, S. Dalli9Armellina: None declared, I. Peene: None declared, G. De Brabanter: None declared, M. Van Den Berghe: None declared, J. Qu: None declared, M. Maertens: None declared, H. Leroi Employee of: MSD

Background Early intensive treatment to target is recommended in severe early Rheumatoid Arthritis (eRA). However, data are lacking in patients presenting without markers of poor prognosis. Objectives To compare Methotrexate (MTX) with or without Glucocorticoid (GC) remission induction in a tight control setting over 52 weeks in low-risk patients with eRA. Methods CareRA is a two year prospective investigator-initiated multicenter RCT rooted in daily practice. DMARD naive eRA patients were stratified into a high or low-risk group according to classical prognostic markers (presence of erosions, rheumatoid factor, anti-cyclic citrullinated protein and disease activity). In the low-risk arm, 43 patients were randomized to 15mg MTX monotherapy following a Tight Step Up (MTX-TSU) approach and 47 patients to a Cobra Slim schedule (MTX+30mg prednisone tapered to 5mg daily from W6). GCs were tapered from W28 and stopped at W34. A predefined treat to target approach was applied. Efficacy measures were proportions of DAS28(CRP) remission, good EULAR response, clinically meaningful HAQ response, HAQ=0 and Area Under the Curve (AUC) for DAS28(CRP) (ITT analysis). Radiographic progression was measured via the Sharp Van der Heijde (SvH) method. Adverse events related to therapy (AEs) were registered. No power was calculated in this explorative study. Missing data were imputed via last observation carried forward. Results Remission rates at week 52 were 57.4% and 67.4% in the MTX-TSU and Cobra Slim group respectively (p=0.329). MTX-TSU patients had a higher AUC for DAS28(CRP) than Cobra Slim patients over 52 weeks of treatment (p=0.017). No other efficacy scores differed between groups. 76% of X-ray images were available at baseline. Radiographic progression was minimal. SvH scores were 0.7±1.1 and 0.9±1.5 at baseline and changed over 52 weeks 0.2±0.3 and 0.3±0.4 in the MTX-TSU and Cobra Slim group respectively (p=0.184). The numbers of AEs were 48 in 27 MTX-TSU patients and 49 in 20 Cobra Slim patients (p=0.871). Two serious AEs (pulmonary infection and anemia) were registered in the Cobra Slim group. We observed numerically more treatment adaptations and IM/IA GC injections in MTX-TSU patients. Conclusions Both RA therapies achieved high remission rates in a tight control setting at week 52. However, remission induction with Cobra Slim resulted in a more rapid and sustained disease control. MTX with or without GC remission induction showed a comparable safety profile. Disclosure of Interest None declared

Background Whereas early intensive treatment to target is recommended in severe early Rheumatoid Arthritis (eRA), few data are available in patients presenting without bad prognostic markers. Objectives To evaluate the efficacy and safety of methotrexate (MTX) monotherapy compared to MTX combined with a glucocorticoid (GC) bridging scheme during the first 16 weeks of treatment in “low risk” eRA patients. Methods CareRA is a prospective two year investigator-initiated multicenter RCT rooted in daily practice. 400 eRA patients were stratified into a high or a low risk group. Low risk was defined as: - No erosions and ACPA and RF negative - Erosions, ACPA and RF negative and low disease activity (DAS28(CRP)≤3.2 - No erosions, ACPA and/or RF positive and low disease activity (DAS28(CRP) ≤3.2 Patients were randomized to 15 mg MTX, either with a bridging scheme of initially 30mg GCs tapered to 5 mg from week (W) 6 (Cobra Slim) or without GCs (MTX Tight Step Up (MTX-TSU)). Treatment modifications to target low disease activity were mandatory from W8 onwards. The primary outcome was remission (DAS28(CRP) Results We included 90 low risk patients: 24.4% were RF positive, 25.6% ACPA positive and 1.1% erosive, with a mean ± SD DAS28(CRP) of 4.53±1.62; 43 patients were randomized in the Cobra Slim and 47 in the MTX-TSU arm. At W16, 65.1% of the Cobra Slim and 46.8% of the MTX-TSU patients were in remission (p=0.081). A good EULAR response was achieved in 44.7% of MTX-TSU and 58.1% COBRA SLIM patients (p=0.202). A clinically meaningful HAQ response was reached in 53.2% of the MTX-TSU and 62.8% of the COBRA SLIM group (p=0.357). More patients had a HAQ=0 at W16 with the Cobra Slim (51.2%) compared to the MTX-TSU (23.4%) schedule (p=0.006). The mean± SD AUC of DAS28(CRP) was 11.18±4.25 and 13.84±4.58 for the Slim and MTX-TSU arm respectively (p=0.006). Treatment adjustments were performed in 27.9% of Slim and 40.4% of MTX-TSU patients (p=0.212). Until W16, therapy related AEs were reported in 39.5% of Slim and in 44.7% of MTX-TSU patients (p=0.622). Conclusions Although the primary outcome, remission, was only numerically different after 16 weeks of treatment, cumulative disease activity over time and proportion with normalized HAQ were in favor of the Cobra Slim group, while related AEs didn9t differ. Disclosure of Interest : None declared DOI 10.1136/annrheumdis-2014-eular.2144

Recently, early intensive treatment has become important in the treatment of rheumatoid arthritis (RA). Evidence from clinical trials and from patient cohorts in daily practice has shown that early disease modifying antirheumatic drug treatment is mandatory to avoid damage and loss of function.1 Therefore, patients with suspicion of RA should be referred to a rheumatologist as soon as possible. This has led to the development of “early arthritis clinics”.2 However, a diagnosis of early RA is difficult for general practitioners (GPs),3 sometimes leading to inappropriate referrals. A solution may be joint consultations of GPs and rheumatologists4 or specific training …

The etiology of B lymphocyte hyperactivity in ankylosing spondylitis (AS) and in reactive synovitis is unknown and data available on the cellular immune system are controversial. We therefore evaluated peripheral blood T cell populations in AS patients and patients with reactive synovitis (RS) using monoclonal antibodies, previously shown to react with all T cells (OKT3), the inducer-helper T cell subset (OKT4) and the suppressor-cytotoxic T cell subset (OKT8). Results were compared with a normal control group and a group of rheumatoid arthritis (RA) patients. In AS an increase of OKT4+ cells was found, but the total number of T helper-inducer cells in peripheral blood was not different from the normal group and the group of patients with RS. Contrary to the results found in RA, where the helper-inducer/suppressor-cytotoxic ratio (OKT4+/OKT8+) was significantly increased, the immunoregulatory ratio in AS and in RS was normal suggesting another mechanism leading to B cell hyperactivity than in RA.

Using monoclonal antibodies of the OKT series, T cell subsets were analyzed in peripheral blood and synovial fluid of patients with rheumatoid arthritis, ankylosing spondylitis and reactive synovitis. In rheumatoid arthritis, a decreased number of T suppressor/cytotoxic cells was found in peripheral blood but not in synovial fluid. In HLA B27 disease B cell hyperreactivity was found to be not related to a disregulation of the immune mechanism.