Rare and often fatal, cutaneous and renal glomerular vasculopathy (CRGV) has attracted much interest since the first UK cases were identified a decade ago. At BVA Live, David Walker will be sharing his knowledge of the disease with the aim of helping practitioners understand when CRGV should be high on their list of differential diagnoses.

Abstract Background Anaemia, thrombocytopenia and leukopenia in rheumatoid arthritis (RA) patients treated with non-Janus Kinase 1 (JAK1) selective inhibitors may be due to inhibition of haematopoietic growth factors signalling through JAK2. Therefore, we investigated anaemia, thrombocytopenia and leukopenia in patients with active RA with prior inadequate response/intolerance to biologic disease-modifying anti-rheumatic drugs (bDMARDs) treated with filgotinib (FIL), a selective JAK1 inhibitor (FINCH-2; NCT02873936). Methods In the randomised, double-blind, placebo-controlled Phase 3 FINCH-2 trial, patients were randomised 1:1:1 to oral FIL 200 mg, 100 mg, or placebo (PBO) once daily plus conventional synthetic DMARDs for 24 weeks. In this subgroup analysis, we assessed shifts from baseline (BL) in haemoglobin (hgb), platelets (plt), neutrophils and lymphocytes. Results A total of 448 patients were treated; FIL 200 mg, n = 147; FIL 100 mg, n = 153; PBO, n = 148. Hgb, plt, lymphocyte and neutrophil counts remained consistent throughout the study. At BL, 28.8%, 0.9%, 2.2% and 5.8% patients had mild–moderate low hgb, plt, neutrophil and lymphocyte, respectively, and 1.1% had severely low lymphocyte levels. Of patients with mild–moderate hgb levels at BL, 13.1% with FIL 200 mg, 9.5% FIL 100 mg, and 7.6% PBO achieved normal hgb at Week 24, respectively (Table). Of those with normal BL hgb, only 6–9.8% had mild low levels at Week 24. Patients with BL mild-moderate low plts and neutrophils had normal levels at Week 24, except one with mild neutropenia on FIL 100 mg. Of patients with normal plt and neutrophil levels at BL, >94% maintained these at Week 24 in all treatment groups. By Week 24, 3.2%, 5.2% and 2.2% of patients treated with FIL 200 mg, FIL 100 mg and PBO, respectively, in the mild–moderate subgroup and 1.7% in the severe subgroup treated with FIL 100 mg had normal lymphocyte counts. Conclusion In this subgroup analysis, most patients with normal hgb, plt, lymphocyte and neutrophil at BL maintained them over 24 weeks of FIL treatment. Of the patients with mild–moderately low hgb at BL, >9% shifted towards normalisation. Similar patterns of improvement were observed for plt, lymphocyte and neutrophil counts. These results suggest that FIL does not increase the incidence of anaemia, thrombocytopenia or leukopenia in patients who entered the study with active RA despite prior bDMARDs.

Filgotinib (FIL) is an oral, selective Janus Kinase 1 inhibitor under development for the treatment of rheumatoid arthritis (RA) and other inflammatory diseases. Safety and efficacy of FIL was investigated in the FINCH clinical program, which includes three Phase 3, randomised, multicentre studies in patients with moderate to severely active RA. FINCH1: patients with inadequate response to MTX (NCT02889796); FINCH2: patients receiving conventional disease-modifying antirheumatic drugs (csDMARDs) with inadequate response to biological DMARDs (NCT02873936); FINCH3: MTX-naïve patients initiating MTX ± FIL, or receiving FIL monotherapy (NCT02886728). We present pooled safety data up to 24 weeks (W24). The FINCH studies enrolled patients with RA (2010 ACR/EULAR criteria), ≥6 swollen joints and ≥6 tender joints at screening and Day 1. Safety analyses included patients receiving ≥1 dose of study drug. Patients in FINCH 1 and 2 who did not experience at least a 20% improvement in both swollen joint count and tender joint count by W14 discontinued study drug and switched to a standard of care. W24 safety data from all studies were aggregated and summarised. Key safety endpoints were treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs of interest, deaths and treatment-emergent laboratory abnormalities. 3452 patients were evaluated; 2088 received FIL. At W24, the frequency of TEAEs and TEAEs of interest were similar for those who received FIL and those in the control groups (Table 1). Most TEAEs were infections. Laboratory abnormality rates were similar between FIL and control groups, and were mild to moderate (grades 1 and 2). Overall, the frequency of major adverse cardiac events, herpes zoster virus, deep vein thrombosis and pulmonary embolism was low, and similar across groups. Pooled data from this large database highlights the favourable safety and tolerability profile of FIL in patients with RA both as monotherapy and in combination with MTX/csDMARD.

Results: Physiotherapist survey: To date 144 physiotherapists have responded with 123 (85%) reporting referral access to an NHS hydrotherapy service.The most frequent AS hydrotherapy service model was six weekly sessions with 45% offering AS group hydrotherapy.31 (32%) reported a fast-access referral pathway for those in flare, 26% offering this access via self-referral and 25% via a telephone helpline.38% of physiotherapists reported barriers to provision.High demand, lack of capacity due to staffing and use of pools by non-NHS groups, impacted on waiting times.One in five hydrotherapy services reported a current threat of closure.Patient survey: To date 256 patients have responded (41% male; average age and disease duration 49 years and 12 years respectively).166 (70%) have accessed NHS hydrotherapy with reported benefits including pain relief, improvement in mood and quality of life, stiffness and flare management.Access is largely initiated by rheumatology team referral (65%), with an additional 26 (17%) patients self-referring.29% stated they could access hydrotherapy when in a flare.Barriers to NHS hydrotherapy included long waiting times and a restriction on the number of sessions offered.26 (13%) have used a pay as you go hydrotherapy service in an NHS facility.Of the respondents who attend a NASS self-help group, 84% have access to hydrotherapy through the group, 71% being provided in a NHS facility.Conclusion: Patients reported similar benefits of hydrotherapy to those stated in the NICE guidance (NG65, 2017), further supporting the best practice recommendations.The survey suggests hydrotherapy services need to continue to be deliverable within the financial restraints of the NHS.However, variability in provision and a 'postcode' impact on access to NHS hydrotherapy exists for AS patients due to pool closures.Hydrotherapy service design to increase pool utilization such as fast-access pathways for flare management, group exercise, and promotion of self-management and pay-as-you-go services may go some way to meet demand and broaden participation whilst ensuring sustainability of services.

Objectives Methotrexate is commonly used to treat patients with inflammatory arthritis. A key role of a rheumatology nurse is to educate patients on how to take this drug safely prior to the commencement of treatment. The objective of the present study was to explore the experiences of rheumatology nurses conducting this role, focusing on the content of the consultation and training received to perform the role. Methods A qualitative phenomenological approach was used. Six semi-structured interviews were performed with nurses from two hospitals who regularly counsel patients prior to starting methotrexate. The interviews were thematically analysed by two researchers and themes extracted. Results Four main themes were identified: (a) using written information to structure the content of the consultation; (b) patients have different information needs; (c) time pressures; and (d) training and evolution of practice. All participants described a lack of confidence when they first started counselling patients commencing methotrexate, with a wide variation in training. Participants reported that patients required different information depending on whether they were commencing this agent on its own or in combination with other drugs. All participants experienced some time pressure. Conclusions Participants reported that the majority of the consultation focused on conveying information, with little opportunity for patient interaction and questions. We suggest that there is a clear need for further exploration of these consultations, to identify possible training needs. Participants also used standard written information to guide both the structure and content of the consultation limiting patients'; opportunities to ask questions.

INTRODUCTIONMethotrexate is routinely used to treat active disease in inflammatory arthritis. There have previously been patient safety concerns associated with methotrexate usage in practice. Most patients commencing methotrexate treatment are seen by the rheumatology nurse, to receive education (often referred to as drug counselling) on this agent prior to starting treatment. Yet, there are no recommended criteria regarding education or experience to ensure minimum competence of the rheumatology nurse. The objectives of the present survey were, firstly, to identify the relevant training experience of rheumatology nurses who provide methotrexate education and, secondly, to explore their confidence and competence in undertaking this role.METHODA national electronic survey of rheumatology nurses, identified via the Royal College of Nursing Rheumatology Forum, national meetings and personal contacts, in order to access nurses who counsel patients on methotrexate, was carried out.RESULTSA total of 104 nurses completed the survey. Reported training was highly variable, ranging from very little to having undertaken MSc courses. Knowledge of the drug was rated as the most important requirement. Confidence was largely very good and was reported to develop with experience, with 80% of participants reporting being confident after 1 year in the role. A small number of participants (four) indicated that they were 'not at all confident'. Aspects of competence and knowledge were assessed using questions on clinical situations; knowledge appeared to be good, with the exception of a question on shingles. Confidence correlated with knowledge (r = 0.21; p = 0.05), amount of training (r = 0.24; p = 0.03) and most strongly with time in the role (r = 0.74; p = 0.00001). The amount of training correlated with confidence but not with knowledge. All participants used written information, often using more than one source, with 87% of participants favouring the Arthritis Research UK information leaflet on methotrexate.CONCLUSIONSThere was a wide variety of training for this role. Confidence seemed to come with experience, training and knowledge, and took many months to develop. A training package in this area may be helpful. Reassuringly, confidence and knowledge were related.

OBJECTIVES:The optimal treatment for active rheumatoid arthritis (RA) is unresolved, particularly in early RA. We used data from an observational cohort to develop the simple predictor algorithm and evaluated its application in two completed clinical trials in early and established RA. We assessed whether using a simple algorithm can identify patients who have persisting active disease despite treatment with disease-modifying drugs (DMARDs). We also examined if patients who have lower likelihoods of persisting active RA are likely to benefit from intensive treatment. METHODS:We developed a simple predictive score for persisting disease activity using conventional clinical assessments in an observational cohort of patients with early RA (ERAN). It was tested in two trials in early (CARDERA) and established (TACIT) RA. Persistent disease activity was defined as disease activity score for 28 joints (DAS28) >3.2 at both 6 and 12 months. RESULTS:Regression modelling identified three main predictors of persisting active disease in ERAN; tender joint counts, health assessment questionnaire (HAQ) scores and ESR. We dichotomised these predictors (≥6 tender joint counts, ≥1.0 HAQ ≥20 mm/h ESR) in a four-point prediction score. This simple prediction score predicted persisting active disease in the ERAN cohort and both CARDERA and TACIT trials. Patients with high scores were more likely to have persistently active disease at 6 and 12 months. The relationship was weaker in TACIT because no patients were without any predictive factors. CONCLUSIONS:Combining tender joint counts, ESR and HAQ in a simple predictive score prospectively identifies patients with higher risks of persistent disease activity over the next 12 months. More patients with all three risk factors had persistent active disease than those with none or one risk factor.

The MRC Vitamin Study Research Group randomised control trial published in 19911 was the first clear demonstration that folic acid supplementation at the time of conception significantly reduces the probability of neural tube defects. Of course, mandatory supplementation of flour is only one of the possible approaches to increasing folate levels in women of childbearing age but with the high rate of pregnancies that are not planned, it is difficult to enable women to ensure that their folic acid levels are high at the time of conception using other forms of supplementation. Promotion of voluntary uptake of folate supplements has been of limited effectiveness and uptake tends to be poor in lower socioeconomic groups, who potentially have the most to gain from supplementation. Mandatory supplementation of flour with folic acid has been adopted as the preferred public health measure for the prevention of neural tube defects in many countries. Since 1991, mandatory …

OBJECTIVES The effectiveness of anakinra (interleukin-1 receptor antagonist) in early rheumatoid arthritis (RA) is unknown. We evaluated the efficacy of anakinra (combined with methotrexate) in a randomised clinical trial of early active RA patients. METHODS The Combination Anti-Rheumatic Drugs in Early RA-2 (CARDERA-2) trial was a randomised trial of early (duration <1 year) active RA. Patients were randomised to 12 months of: (1) methotrexate or (2) anakinra-methotrexate. Follow-up lasted 2 years. The primary outcome was erosive progression (changes from baseline in modified Larsen scores). Secondary outcomes were changes from baseline in disease activity score on a 28-joint count (DAS28), health assessment questionnaire (HAQ), and quality of life (EQ-5D) scores alongside ACR responder rates. RESULTS 154 patients received the allocated intervention (from 259 screened). Similar Larsen score progression was seen at 12 and 24 months in patients receiving anakinra-methotrexate (mean changes from baseline of 2.50 and 5.10, respectively) and methotrexate monotherapy (mean changes from baseline of 4.16 and 5.20, respectively). Lower improvements in DAS28 and HAQ scores were seen at all time-points in anakinra-methotrexate treated patients; these were significantly less at 24 months (DAS28 p=0.04; HAQ P=0.02). Significantly lower EQ-5D score increases were seen at 12 months with anakinra-methotrexate (p=0.03). Anakinra-methotrexate was associated with more serious adverse events compared with methotrexate monotherapy (11 vs. 6 patients), although this was not significant (p=0.59). CONCLUSIONS Anakinra (combined with methotrexate) is not effective in early, active RA. It provided no clinical benefits beyond methotrexate monotherapy.

Tackling infectious disease, coping with climate change, boosting growth – the major challenges facing our society and economy demand sharp social science. This 2015 pre-election report from the Campaign for Social Science makes urgent recommendations – on research funding, social science capacity and use of expert advice by government – to maximise social science’s contribution through the next Parliament and beyond.

Background:The education of patients is a central part of the nursing role in the UK.Nowhere is it more important than in relation to drugs such as MTX, where the effect is delayed and side effects are anticipated.Nurses had expressed variable confidence in educating patients starting MTX.We were interested to explore these issues in semi-structured interviews with nurses engaged in this role.Methods: Six nurses who perform this role in two large units were interviewed.They were all monitoring rather than specialist nurses and worked in two different systems.In the first system patients were educated on the spot and in the second patients were given appointments to return to a dedicated clinic.The interview schedule covered: training; teaching session content; written information used; time and confidence.The interviews were transcribed and analysed using framework analysis a standard qualitative methodology.Results: All nurses used a written leaflet or checklist to dictate the content of the education.All covered the important side effects, how to take it and how the monitoring and prescription system worked.The checklist did, however, have the effect of making a one way dialogue described as their speech (or spiel) and nurses described being interrupted or thrown off track by patient questions.None of the participants were able to describe a recent teaching session without reference to the leaflet they used.Checking of the patient's knowledge and understanding prior to the education did not occur.It was assumed that patients who were already on DMARDs did not require as much education: they just need an overview -like the side effects and you don't go into it as much.Similarly a checking for understanding during the delivery of the education was also missing.Some nurses felt they were under time pressure bombarding the patient with information.This was found in both systems, even with specific appointments.Questions about the disease, rather than the drug, were usually side stepped with an offer to arrange an appointment with a specialist nurse.Training was generally confined to observing the process then they got on with it. Conclusion:The content of these educational encounters relied heavily on the written materials.This material also seemed to constrain the encounter with an overwhelming need to get through it.Delivery of information was constant and nurses felt that they were bombarding patients with information leaving them feeling dazed and overwhelmed.The nurses quickly established good rapports with their patients, but their consultation skills may require further development.

INTRODUCTIONMethotrexate is commonly used in patients with inflammatory arthritis. The aim of the present study was to ascertain the prevalence of side effects that patients on methotrexate were tolerating and to establish their adherence to the medication.METHODA questionnaire was developed for completion by the healthcare professional with the patient, and piloted in one centre. The questionnaire was then used in six other centres, with the addition of a question about the attractiveness of stopping methotrexate treatment. Efficacy and toxicities were scored for severity on a 10-cm visual analogue scale (VAS). Adherence to the drug was also explored.RESULTSThe prevalence of 'any side effect' ranged from 57% to 86%. The most frequent side effects were fatigue (53%); nausea (38%); mouth ulcers (23%) and hair loss (23%). Efficacy averaged 6.5 cm on the VAS. Results from the combined survey revealed that toxicity averaged 5.9 cm for fatigue, 4.8 cm for nausea, 4.4 for mouth ulcers, 3.9 cm for hair loss and 5.7 cm for 'other' side effects. 13.5% of patients revealed that they had forgotten to take the drug for an average of two weeks, and 25% for an average of 2.5 weeks in the previous year. Participants were more likely to reveal this to a nurse than a doctor.CONCLUSIONPatients put up with a considerable number of side effects in order to benefit from methotrexate therapy. Adherence to this drug merits further study. Copyright © 2015 John Wiley & Sons, Ltd.