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Background: Gel-200 is a cross-linked hyaluronate single-injection device for treatment of osteoarthritis pain in the knee. This report summarizes new analyses of the safety of retreatment with Gel-200 from the 13-week, pivotal, multicenter, randomized controlled trial (RCT) followed by an open-label extension trial (OLE).Methods: 379 patients were enrolled in the RCT [Gel-200; phosphate-buffered saline (PBS)]. Safety of retreatment with Gel-200 was assessed by comparing adverse events (AEs) and device-related AEs reported through Week 4 following retreatment with Gel-200 to those reported in patients receiving their first injection in the OLE.Results: 350 patients completed the initial RCT (231 Gel-200; 119 PBS); 258 patients enrolled in the OLE (162 Gel-200; 96 PBS). In total, 202 patients (125 Gel-200; 77 PBS) qualified for retreatment, while 56 (37 Gel-200; 19 PBS) did not. There were no significant demographic or disease characteristic differences between Gel-200 patients who were and were not retreated; those who were not eligible for retreatment experienced greater pain relief from Gel-200 in the RCT by all effectiveness endpoints (all p < 0.001), without differences in their safety profile. In the OLE, the safety of Gel-200, including percentages of patients who experienced any AEs (p = 0.547) and device-related AEs (p = 0.521), did not significantly differ between those receiving a second versus a first injection of Gel-200 following PBS in the RCT.Conclusion: In the OLE, the safety of a second injection of Gel-200 was comparable to that of a first injection and effectiveness was similar, as previously reported.Trial Registration: ClinicalTrials.gov identification numbers NTC 00449696 and NTC 00450112. [ABSTRACT FROM AUTHOR]

To determine whether an elevated serum total cholesterol level in a first‐available sample obtained at a systemic lupus erythematosus (SLE) clinic is associated with worse renal outcome in patients with SLE.Survival analysis methods were used on prospectively gathered data on 1,060 patients with SLE who were registered in the University of Toronto Lupus Databank. The effect of total cholesterol and 15 additional variables on the outcomes of renal deterioration, end‐stage renal disease (ESRD), and death was assessed using Cox proportional hazards methods.In 474 (45%) of the 1,060 patients, the total cholesterol level exceeded 5.2 mmoles/liter. In the entire study group, the median total cholesterol level was 5.1 mmoles/liter (range 1.6–17.1). During a mean followup period of 8.8 years, 93 patients (9%) experienced renal deterioration, 42 patients (4%) had ESRD, and 161 deaths occurred, 48 (30%) of which were associated with renal dysfunction (renal death), and 113 (70%) of which were not associated with renal dysfunction (nonrenal death). Kaplan‐Meier survival estimates for each outcome were statistically significantly different between patients with normal versus those with elevated total cholesterol levels (cutoff 5.2 mmoles/liter), with a worse outcome observed among those with an elevated total cholesterol concentration. In multivariate analyses, total cholesterol level (hazard ratio [HR] 1.17, 95 confidence interval [95% CI] 1.01–1.36), serum creatinine level (HR 1.06, 95% CI 1.04–1.07), proteinuria (HR 2.44, 95% CI 1.25–4.76), the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (HR 1.44, 95% CI 1.16–1.80), and corticosteroid dose (HR 1.01, 95% CI 1.00–1.02) were associated with renal deterioration. Significant predictors of ESRD were baseline proteinuria (HR 6.24, 95% CI 1.96–19.88) and serum creatinine level (HR 1.15, 95% CI 1.08–1.22). The total cholesterol level was correlated with death (HR 1.20, 95% CI 1.11–1.29), retaining statistical significance for renal death (HR 1.33, 95% CI 1.20–1.47) but not for nonrenal death (HR 1.12, 95% CI 0.99–1.25).Those results indicate that an elevated serum total cholesterol level in a first‐available sample obtained at an SLE clinic is associated with adverse renal outcomes and mortality. [ABSTRACT FROM AUTHOR]

Objectives: Real-world evidence regarding prevalence, patient characteristics, and treatment patterns for pulmonary arterial hypertension (PAH) related to systemic lupus erythematosus (SLE) in Japan is limited. Methods: We conducted a retrospective study analysing Japan's Medical Data Vision database from April 2008 to September 2020. Prevalence, incidence, patient characteristics, treatment patterns, and use of vasodilators by treatment line were evaluated. Results: The prevalence of PAH was 0.392% in SLE patients (n = 114/29,077). Cumulative incidence was 0.53% (3 years) and 0.77% (5 years). Of 114 SLE–PAH patients, 49% developed PAH <1 year from SLE diagnosis. SLE–PAH patients were predominantly females (88% vs. 72%), had a lower mean age at SLE diagnosis (53 vs. 56 years), and had more severe SLE (61% vs. 25%) than non-PAH–SLE patients. Glucocorticoids (58%) and vasodilators (27%) were preferred first-line monotherapy for SLE–PAH. A combination of glucocorticoids and immunosuppressants (19%) was the predominant first-line combination therapy. Endothelin receptor antagonists (40% and 44%) and nitric oxide analogues (31% and 40%) were dominant first- and second-line vasodilators. Conclusions: SLE–PAH patients were predominantly females, were younger at diagnosis, and had more severe SLE than non-PAH–SLE patients. Most were diagnosed <1 year of SLE diagnosis. In Japan's real-world practice, the initial treatment goal is SLE management, while vasodilators are preferred in advanced diseases, as per the Medical Data Vision database. [ABSTRACT FROM AUTHOR]