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Introduction: Although lung volume reduction surgery and bronchoscopic lung volume reduction with endobronchial valves have both been shown to improve lung function, exercise capacity and quality of life in appropriately selected patients with emphysema, there are no direct comparison data between the two procedures to inform clinical decision making. Methods and Analysis: We describe the protocol of the CELEB study (ISRCTN19684749), a randomised controlled trial which will compare outcomes at 1 year between the two procedures, using a composite disease severity measure, the iBODE score, which includes body mass index, lung function, breathlessness and exercise capacity. Ethics and Dissemination: Ethical approval to conduct the study has been obtained from the Fulham Research Ethics Committee, London (16/LO/0286). The outcome of this trial will provide information to guide treatment choices in this population and will be presented at national and international meetings and published in peer-reviewed journals. We will also disseminate the main results to all participants in a letter.

Objectives. To investigate the long term persistence of rituximab (RTX) in a large observational RA cohort, investigate persistence of RTX when used as a first or second line biologic DMARD (bDMARD), to characterize subsequent bDMARD treatment following RTX. Methods. Patients with RA starting treatment with RTX (MabThera) between 2008 and 2011 were recruited into the British Society for Rheumatology Biologics Register for RA. Duration of RTX treatment over the first 4 years after initiation was estimated via Kaplan-Meier estimates and the reason for discontinuation was ascertained. Subsequent bDMARD use following RTX discontinuation was characterised. Treatment survival in bDMARD-naive (first line RTX use) and experienced (second line RTX use) cohorts was described. Results. One thousand six hundred and twenty-nine patients were recruited (1371 bDMARD-experienced and 258 bDMARD-naïve). Sixty percent of the whole cohort remained on RTX after 4 years. Ineffectiveness (46%) and death (24%) were the most common reason for RTX discontinuation. RTX discontinuation was associated with RF negativity for the bDMARD-experienced cohort. Of those that discontinued RTX, 46% initiated treatment with another bDMARD, with tocilizumab being the most common. Conclusion. This large study of patients initiating RTX treatment for severe RA found that 60% persisted with treatment after 4 years. This study also identified that RTX is tolerated well when used as a first or second line bDMARD.

Objective Epratuzumab, a monoclonal antibody that targets CD22, modulates B cell signaling without substantial reductions in the number of B cells. The aim of this study was to report the results of 2 phase III multicenter randomized, double‐blind, placebo‐controlled trials, the EMBODY 1 and EMBODY 2 trials, assessing the efficacy and safety of epratuzumab in patients with moderately to severely active systemic lupus erythematosus (SLE). Methods Patients met ≥4 of the American College of Rheumatology revised classification criteria for SLE, were positive for antinuclear antibodies and/or anti–double‐stranded DNA antibodies, had an SLE Disease Activity Index 2000 (SLEDAI‐2K) score of ≥6 (increased disease activity), had British Isles Lupus Assessment Group 2004 index (BILAG‐2004) scores of grade A (severe disease activity) in ≥1 body system or grade B (moderate disease activity) in ≥2 body systems (in the mucocutaneous, musculoskeletal, or cardiorespiratory domains), and were receiving standard therapy, including mandatory treatment with corticosteroids (5–60 mg/day). BILAG‐2004 grade A scores in the renal and central nervous system domains were excluded. Patients were randomized 1:1:1 to receive either placebo, epratuzumab 600 mg every week, or epratuzumab 1,200 mg every other week, with infusions delivered for the first 4 weeks of each 12‐week dosing cycle, for 4 cycles. Patients across all 3 treatment groups also continued with their standard therapy. The primary end point was the response rate at week 48 according to the BILAG‐based Combined Lupus Assessment (BICLA) definition, requiring improvement in the BILAG‐2004 score, no worsening in the BILAG‐2004 score, SLEDAI‐2K score, or physician's global assessment of disease activity, and no disallowed changes in concomitant medications. Patients who discontinued the study medication were classified as nonresponders. Results In the EMBODY 1 and EMBODY 2 trials of epratuzumab, 793 patients and 791 patients, respectively, were randomized, 786 (99.1%) and 788 (99.6%), respectively, received study medication, and 528 (66.6%) and 533 (67.4%), respectively, completed the study. There was no statistically significant difference in the primary end point between the groups, with the week 48 BICLA response rates being similar between the epratuzumab groups and the placebo group (response rates ranging from 33.5% to 39.8%). No new safety signals were identified. Conclusion In patients with moderate or severely active SLE, treatment with epratuzumab + standard therapy did not result in improvements in response rates over that observed in the placebo + standard therapy group.

Objective: The main aim of this survey was to determine the frequency of self-reported lower limb or foot and ankle complications experienced by participants with SLE. A secondary aim was to determine the frequency of treatments that have been received or that participants with SLE may like to receive if offered.Method: A quantitative, cross-sectional, self-reported survey design was utilised. The developed survey was checked for face and content validity prior to patient partner cognitive debriefing in order to ensure usability, understanding of the process of completion and of the questions posed. The full protocol for survey development has been published previously.Results: This is the first comprehensive national UK survey of lower limb and foot health problems reported by participants with SLE. A high prevalence of vascular, dermatological and musculoskeletal complications was reported by survey respondents. Additionally, whilst the relative prevalence of sensory loss was low, a quarter of people reported having had a fall related to changes in foot sensation demonstrating a previously unknown rate and cause of falls.Conclusion: Complications related to vascular, dermatological and musculoskeletal health are identified as particularly prevalent in participants with SLE. Further, there is a suggestion that the provision of interventions to maintain lower limb health is highly varied and lacks national standardisation, despite there being a strong indication of participant reported need. The findings of this work can be used to inform care guideline development in addition to identifying areas for future research.

Background: Along with its skin manifestations, SLE can present with\ud a variety of musculoskeletal signs and symptoms and vascular\ud problems that can affect the feet. Furthermore, there is the potential\ud for reduced tissue viability, leading to thinning of the skin and/or callus\ud formation. Further, systemic resistance to viral, bacterial and fungal\ud infections may be reduced and, together with poor tissue viability,\ud create the opportunity for these infections to proliferate in the feet. A\ud recent survey by the same authors (unpublished) has shown a high\ud prevalence of these infections, with many experiencing the impact of\ud vascular and musculoskeletal problems. To date there is no research\ud that has explored the impact of foot problems on people’s lives.\ud Methods: Following ethical approval, 12 participants who fulfilled the\ud inclusion criteria were recruited: diagnosed with SLE (ACR diagnosis),\ud current and/or past experience of foot/lower limb problems and age\ud �18 years. Consent was obtained and then conversational-style\ud interviews were carried out with an interpretivistic phenomenological\ud approach. The interviews were digitally recorded and complemented\ud by field notes. An opening question was used for all participants: ‘Tell\ud me about your experiences of having foot problems?’ If necessary,\ud further trigger questions were used in order to maintain the conversation\ud and the focus on foot problems. Data were transcribed verbatim\ud and analysed using a thematic framework approach. The transcripts\ud were verified by the participants and were analysed by a second\ud researcher in order to add to the credibility of the analyses.\ud Results: The data was organized into seven themes: Foot problems\ud and symptoms—what they are and the feeling associated with them;\ud Experiences of foot problems being diagnosed; Impact of foot\ud problems on activities; Treatment of foot symptoms/problems;\ud Perceived obstacles to professional foot care; Unanswered questions\ud about feet and foot care; and Recognition of the need for professional\ud foot care and foot care advice. These people experienced a wide\ud variety of foot problems that impact significantly on activities. Some\ud reported working through the pain in order to achieve visible normality\ud while experiencing the negative emotions of anger, frustration and\ud anxiety. Although some had experienced professional foot care, there\ud were obstacles to the foot problems being diagnosed, resulting in\ud many unanswered questions and some inappropriate selfmanagement.\ud Conclusion: Despite reporting foot pain, negative emotions and\ud activity restrictions related to their foot symptoms, people with SLE\ud tend to get on with it and self-treat rather than seeking professional\ud foot care. The lack of focus on the feet in the medical consultation is\ud caused by the participants’ belief that it is not the consultant’s role.\ud There is a clear need for foot assessments to be included in the\ud medical consultation and for professional foot care to be provided.

Background: SLE can affect many tissues throughout the body.\ud Anecdotally, it is suggested that people with SLE experience a range of\ud complications in the foot and lower limb, including vascular impairment\ud (e.g. RP), neurological impairment, poor tissue viability (e.g. ulceration),\ud infection and foot pain. However, to date, the precise prevalence of foot\ud complications experienced by people with SLE has not been described.\ud The aim of this survey was to determine self-reported foot and lower\ud limb complications experienced by people with SLE.\ud Methods: The survey was developed via patient and practitioner focus\ud groups. A consensus approach was used to generate items and to\ud formulate themes, categories, question format and survey structure.\ud The survey was checked for face and content validity prior to cognitive\ud debriefing to ensure usability and understanding. Consecutive patients\ud with a confirmed diagnosis of SLE meeting the inclusion criteria\ud attending any of seven UK clinical sites or members of Lupus UK were\ud invited to participate. Ethical approval and participant informed\ud consent was obtained.\ud Results: A total of 182 survey responses were completed. For all\ud responders, the most frequent age range was 40–49 years, mean BMI\ud was 27 (S.D. 7) and mean disease duration was 15 years (S.D. 10). A\ud number of vascular complications were reported, including intermittent\ud claudication [n ¼ 100 (55%)], RP [n ¼ 94 (52%)] and splinter\ud haemorrhage [n ¼ 39 (21%)]. Overall, 164 patients (90%) reported\ud experiencing symptoms of peripheral vascular complications.\ud Symptoms of peripheral neuropathy were reported by 30 patients\ud (16%), while a fall as a consequence of neuropathic symptoms was\ud reported by 45 patients (25%). A range of skin and nail complications\ud were reported, including callus or corns [n ¼ 130 (71%)], onychocryptosis\ud [n ¼ 69 (38%)], rashes or blistering [n ¼ 62 (34%)] and ulceration\ud [n ¼ 45 (25%)]. A high prevalence of infection was reported; a history of\ud viral infection (verrucae pedis) or fungal infection (tinea pedis) was\ud reported by 77 patients (42%), bacterial infection by 28 patients (15%)\ud and onychomycosis by 65 patients (36%). Overall, 170 patients (93%)\ud reported having experienced some form of tissue viability complication.\ud Foot joint pain, stiffness and swelling was reported by 145 (80%), 136\ud (75%) and 94 (52%) patients, respectively. Foot-related walking\ud impairment was reported by 67 patients (37%). Only 60 patients\ud (33%) reported having ever been asked about their feet by a medical\ud professional. Seventy-seven patients (42%) reported that they would\ud benefit from the provision of general foot health care advice.\ud Conclusion: A large number of people with SLE report vascular\ud complications, impaired tissue viability, musculoskeletal problems and\ud foot pain, as well as a range of infections and conditions of the skin\ud and nails. Despite this, foot health assessment by professionals was\ud infrequent. These results highlight the need to undertake clinical\ud studies investigating lower limb pathologies in SLE.