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Objective.To evaluate the efficacy/safety of belimumab plus standard therapy in patients (n = 449) with active systemic lupus erythematosus (SLE) treated up to 7 years (n = 177 currently ongoing).Methods.Patients (n = 345) who completed a double-blind, placebo-controlled, 52-week study of belimumab 1, 4, or 10 mg/kg and 24-week extension of belimumab (placebo switched to 10 mg/kg; belimumab same dose or switched to 10 mg/kg) could receive belimumab 10 mg/kg in an open-label continuation study (n = 296). Disease activity was analyzed in patients with active SLE at baseline of the initial study. Biomarker and SLE medication changes were evaluated, and adverse events (AE) were monitored throughout the study.Results.Total belimumab exposure over 7 years (double-blind and open-label periods): 1746 patient-years. SLE Responder Index (SRI) response rates at Week 52 in autoantibody-positive patients: placebo, 29%; belimumab, 46% (p < 0.05). In the continuation study, 57% of auto-antibody-positive patients had an SRI response by Year 2 and 65% by Year 7; severe flares occurred in 19% with placebo and 17% with belimumab during the first year, with the annual rate declining to 2%–9% during years 2–7. Anti-dsDNA autoantibodies in patients positive for them at baseline had a progressive decline of 40%–60% from baseline over 2–7 years with belimumab. Corticosteroid use decreased over time with ≥ 50–55% reduction in median dose during years 5–7. Serious and overall annual AE rates, including infections, were generally stable or decreased during 7-year treatment.Conclusion.Disease control and safety profile were maintained in patients with active SLE taking belimumab plus standard therapy for up to 7 years. [ClinicalTrials.govnumbers: NCT00071487 and NCT00583362]

Robert Katz and Charles Ruck, Latham & Watkins [ABSTRACT FROM AUTHOR]

ObjectiveThe Systemic Lupus International Collaborating ClinicsAmerican College of Rheumatology Damage Index SDI is a validated instrument for assessing organ damage in systemic lupus erythematosus SLE. Trained physicians must complete it, thus limiting utility where this is impossible.MethodsWe developed and pilot tested a selfassessed organ damage instrument, the Lupus Damage Index Questionnaire LDIQ, in 37 SLE subjects and 7 physicians. After refinement, 569 Englishspeaking SLE subjects and 14 rheumatologists from 11 international SLE clinics participated in validation. Subjects and physicians completed the instruments separately. We calculated sensitivity, specificity, Spearmans correlations, and agreement using the SDI as the gold standard. Six hundred five SLE participants in the communitybased National Data Bank for Rheumatic Diseases NDB study completed the LDIQ and we assessed correlations with outcome and disability measures.ResultsThe mean LDIQ score was 3.3 range 0–16 and the mean SDI score was 1.5 range 0–9. The LDIQ had a moderately high correlation with the SDI Spearmans r 0.50, P< 0.001. Specificities of individual LDIQ items were >80, except for neuropathy. Sensitivities were variable and lowest for damage, with <1 prevalence. Agreement between the SDI and LDIQ was >85 for all but neuropathy, reduced renal function, deforming arthritis, and alopecia. In the NDB, the LDIQ correlated well with the comorbidity index r 0.45, the Short Form 36 physical component scale r 0.43, the Medical Research Council dyspnea scale r 0.40, disability r 0.37, and the Systemic Lupus Erythematosus Activity Questionnaire score r 0.37.ConclusionThe metric properties of the LDIQ are good compared with the SDI. It has construct validity and correlations with health assessments similar to the SDI. The LDIQ should allow expansion of SLE research. Its ultimate value will be determined in longitudinal studies.

OBJECTIVE: The Medical Outcomes Study Short-form 36 (SF-36) provides numerical measurement of patient health, but does not include preferences for health states and cannot be used directly in cost-effectiveness analyses. By contrast the Euroqol EQ-5D can be used for cost-effectiveness analyses. The EQ-5D has rarely been used in systemic lupus erythematosus (SLE). We compared SF-36 and EQ-5D values across rheumatic diseases. METHODS: We studied 1316 patients with SLE, 13,722 with rheumatoid arthritis (RA), 3623 with non-inflammatory rheumatic disorders (NIRD), and 2733 with fibromyalgia (FM). RESULTS: The mean EQ-5D, physical (PCS) and mental (MCS) component summary scores were 0.72, 36.3, and 44.3, respectively, in SLE. There was essentially no difference among EQ-5D and PCS scores for patients with SLE, RA, or NIRD. MCS was lower in SLE compared with RA and NIRD (44.3, 49.1, 50.8, respectively). All scores were more abnormal in FM (0.61, 31.9, 41.9). Within SF-36 domains, physical function was better, but general health, vitality, social function, role-emotional, and mental health were more impaired in SLE compared with RA and NIRD. In SLE, quality of life (QOL) was predicted by damage, comorbidity, income, education, and age. Fifteen percent of patients with SLE were very satisfied with their health, and their QOL scores (0.84, 45.4, 50.1) were similar to those found in the US population for EQ-5D and MCS, but were slightly reduced for PCS. CONCLUSION: EQ-5D and PCS are at the same levels in SLE as in RA and NIRD, but are more abnormal in SLE in the MCS and mental health domains. EQ-5D values allow preference-based comparisons with other chronic conditions.

ObjectiveTo examine the impact of distraction on the retention of rehearsed information in patients with fibromyalgia syndrome FMS.MethodsData refer to the neurocognitive examination of 134 patients 91 with FMS and 43 control subjects presenting with memory loss. Four neurocognitive measures free of distraction, along with 2 measures with added distraction, were completed. Differences in the retention of rehearsed and unrehearsed information with a source of distraction present were calculated.ResultsPatients with FMS showed normal cognitive functioning on verbal memory tests free of distraction. Adding a source of distraction caused unrefreshed information to be lost at a disproportionate rate in patients with FMS. Over 87 of patients with FMS scored in the impaired range on a task of unrehearsed verbal memory. Adding a source of distraction to wellrehearsed information produced a normal rate of recall in FMS.ConclusionRehearsal mechanisms are intact in patients with FMS and play beneficial roles in managing interference from a source of distraction. In the absence of rehearsal, a source of distraction added to unrefreshed information signals a remarkable level of cognitive deficit in FMS that goes undetected by conventionally reliedupon neurocognitive measures. We present a theory to promote understanding of the cognitive deficit of people with FMS based on reduced speed of lexical activation and poor recall after distraction.

OBJECTIVE: Patients with fibromyalgia (FM) frequently complain of poor memory, severe enough to affect job performance and to lead to disability. Yet common practices in neurocognitive examinations often fail to document cognitive abnormalities that match the severity of their memory complaints. Often, neuropsychologists gauge memory competence with measures free of distraction and produce high rates of normality on neurocognitive examination. We hypothesized that neurocognitive tests encoded with a source of stimulus competition that interferes with the processing and/or absorption of information would be better than others in gauging FM memory competence. METHODS: Thirty-five patients with FM and 35 controls, matched for age and sex, and presenting with complaints of memory loss, completed cognitive measures with and without stimulus competition. RESULTS: Eleven (31.4%) patients with FM showed impairment on at least one measure of memory encoded free of stimulus competition. By comparison, 30 (85.7%) showed impairment on at least one measure encoded with a source of stimulus competition. The Auditory Consonant Trigram detected impairment in 29 (82.6%) cases, and was by far the most sensitive measure. FM patients lost information at a 58% rate following a 9 second distraction. This loss was disproportionate to the loss shown by both age matched controls with memory problems (40%) and to normative values (20%) based on individuals free of memory problems. CONCLUSION: The findings validate the perception of failing memory in patients with FM and are the first psychometric based evidence to our knowledge of short-term memory problems in FM linked to interference from a source of distraction. Adding a source of distraction caused the majority of FM patients to retain new information poorly, and may be integral to an understanding of FM memory problems. Much needs to be learned about why new information is disproportionately lost by FM populations when a source of distraction enters the experiential field.

OBJECTIVE. Jaw pain may occur in rheumatoid arthritis (RA), osteoarthritis (OA), and fibromyalgia (FM). We investigated the prevalence and correlates of jaw pain, and whether jaw pain is increased in RA, where intrinsic articular disease can be noted radiographically, or is a manifestation of a generalized pain problem. METHODS: We analyzed data from 22,720 patients participating in a longitudinal outcome study of rheumatic diseases, including 17,683 with RA, 4,011 with OA, and 1,026 with FM. Jaw pain was considered to be present if a patient indicated it in either the left or right jaw. In addition to standard rheumatic disease measures, we also obtained self-report assessments that included a count of painful nonarticular regions (the regional pain score, RPS), a joint count, and a count of symptoms. RESULTS: The age and sex adjusted rate of jaw pain was 18.7% in RA, 18.6% in OA, and 35.4% in FM. Jaw pain was best predicted by joint count, RPS, and a count of somatic symptoms in univariate analyses. In multivariate analyses jaw pain was predicted by joint count, RPS, symptom count, and fatigue. The ROC area under the curve for this model was 0.79, and 82.8% of patients were correctly classified. There was little difference in predictor variables for RA and OA patients. Covariate adjusted analyses controlling for age, sex, symptom count, fatigue, RPS, and joint count predicted jaw pain in 14.7% (95% CI 14.1 to 15.3) of RA and 11.6% (95% CI 10.6 to 12.7) of OA patients. This difference, 3.1%, may represent the increment in jaw pain attributable to RA. CONCLUSION: Jaw pain is present in about 19% of patients with RA and OA, and is primarily a marker for a general pain increase and symptom sensitivity problem. Patients who have jaw pain have worse outcomes manifested by decreased functional ability, lower household income, and decreased quality of life. Variables not usually formally measured in clinical practice best identify this problem: self-reported joint count, symptom count, count of painful regions (RPS), and a visual analog scale for fatigue.

The article focuses on the role of attorneys following commercial credit fraud. There are numerous reasons that people commit fraud. Most attorneys will find that their client committed fraud because they found themselves in a desperate situation or became greedy. Attorneys can often play a key role as a result of their relationships with investment bankers, equity funds, consultants, etc., or at their partners' contacts or network base. Clients expect their attorneys to have the resources and contacts to bring people to the table.