Quality assurance study of the use of preventative therapies in glucocorticoid-induced osteoporosis in early inflammatory arthritis: results from the CATCH cohort.

OBJECTIVE: To characterize steroid use and compliance with glucocorticoid-induced osteoporosis (GIOP) guidelines within a large early inflammatory arthritis cohort. METHODS: Using the Canadian Early Arthritis Cohort (CATCH) database, patients with inflammatory arthritis on glucocorticoids (oral, IA and i.m.) were identified. Consecutive steroid exposure was defined as using glucocorticoids for two consecutive clinic visits (at least 90 days apart). The primary outcome was the proportion of patients receiving calcium, vitamin D and a bisphosphonate among patients treated with consecutive oral glucocorticoids. RESULTS: Six hundred and fifty-five patients were in the CATCH database, where 273 patients were identified as glucocorticoid users, of whom 48% were on oral prednisone, 38% received i.m. or IA and 13% both. The median oral daily dose of prednisone was 5 mg (interquartile range 2.5-10). Consecutive users (CUs, n = 78) compared with non-consecutive users (NUs, n = 532) showed that CUs were older (56 vs 50 years, P = 0.001); females were fewer (63% vs 74%, P = 0.04), but a similar proportion were RF positive (51% in CU vs 56% in NU, P = 0.73). For the primary outcome, rates of prophylaxis for users of consecutive oral steroids were as follows: 53% were treated with calcium, 47% with vitamin D and 25% were on a bisphosphonate. For users of oral prednisone at doses ≥7.5 mg/day, rates of prophylaxis were as follows: 64% were treated with calcium, 57% with vitamin D and 21% were on a bisphosphonate. CONCLUSION: Glucocorticoid therapy is frequently used in early inflammatory arthritis. The use of calcium, vitamin D or a bisphosphonate was low among chronic glucocorticoid users and illustrates the need for more diligence in patients receiving glucocorticoids to prevent GIOP.

Steroid-sparing effects of methotrexate in systemic lupus erythematosus: a double-blind, randomized, placebo-controlled trial.

OBJECTIVE: To assess the potential benefits of methotrexate in patients with systemic lupus erythematosus (SLE). METHODS: A 12-month, double-blind, placebo-controlled trial of methotrexate with folic acid was conducted. Intent-to-treat analyses were performed with mixed linear models and alpha = 0.04 (96% confidence interval [96% CI]) to account for interim analysis of longitudinal data to assess the treatment effects on lupus disease activity and daily steroid dose across monthly measurements, and to test if the treatment effects depended on selected participant characteristics. RESULTS: Of 215 participants screened, 94 were excluded, 35 declined, and 86 were randomized (methotrexate = 41, placebo = 45). The groups were balanced for demographic and disease characteristics. Antimalarial use was more frequent in the placebo group, which was adjusted for in multivariable analyses. Sixty participants (27 methotrexate, 33 placebo) completed the study and 26 terminated early. Among participants who had the same baseline prednisone dose, those taking methotrexate received, on average, 1.33 mg/day less prednisone during the trial period (96% CI 0.06, 2.72 mg/day; a 22% reduction of their average-during-trial daily dose) compared with those in the placebo group. For the primary measure of disease activity (revised Systemic Lupus Activity Measure), methotrexate use was also associated with a marginally significant reduction in the mean during-trial score of 0.86 units (96% CI 0.01, 1.71; P = 0.039). A significant interaction between treatment and baseline damage was found (P = 0.001). CONCLUSION: Methotrexate conferred a significant advantage in participants with moderately active lupus by lowering daily prednisone dose and slightly decreasing lupus disease activity. As a therapeutic option in moderate SLE, methotrexate can be considered to be steroid sparing.

Timing of total joint replacement affects clinical outcomes among patients with osteoarthritis of the hip or knee.

OBJECTIVE: To determine the predictors of outcome in patients with osteoarthritis 2 years after receiving total hip or knee replacement. METHODS: A prospective cohort study of 222 osteoarthritis patients undergoing total hip or knee replacement in Boston and Montreal was done. Their postoperative outcomes at 6 months were previously reported. This followup reports on the outcomes after 2 years among the 165 patients (74%) who remained. The subjects were divided into 2 groups according to the median value of their preoperative Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score. The Short Form 36-item physical function subscale and the WOMAC pain and function subscale scores were collected at baseline and at 3, 6, and 24 months postoperatively. Clinical outcomes were analyzed at 2 years, using descriptive and multiple regression analyses. RESULTS: Improvements in pain and function at 2 years were similar to those observed at 6 months. Those subjects with the worst function and pain at the time of surgery (baseline) had comparatively worse function 2 years after surgery. CONCLUSION: In this comparison, the poor outcomes observed at 6 months following total joint replacement in patients with worse baseline functional status persisted after 2 years. Although there are no validated indications for when a patient should optimally have total joint replacement, these data suggest that timing of surgery may be more important than previously realized and, specifically, that performing surgery earlier in the course of functional decline may be associated with better outcome.

Organ manifestations influence differently the responsiveness of 2 lupus disease activity measures, according to patients' or physicians' evaluations of recent lupus activity.

OBJECTIVE: To determine (1) which organ system manifestations contribute to the overall responsiveness of the Systemic Lupus Activity Measure (SLAM, revised 1991 with minor modifications as SLAM-R) and the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI); and (2) whether responsive items differ for physicians and patients. METHODS: Blinded data were obtained from repeated visits of 76 patients in the Study of Methotrexate in Lupus Erythematosus. At each visit, physicians and patients reported improvement, no change, or deterioration, and physicians then completed SLAM-R and SLEDAI. Items in SLAM-R and SLEDAI were grouped by organ system. The generalized estimating equations approach was used to measure associations between change in organ system activity and physician or patient perception of change in overall disease activity. The outcomes assessed, in separate analyses, were improvement and deterioration from the previous visit. RESULTS: Seventy-six patients contributed a total of 471 observations. The strongest correlates of physician-reported improvement were decreased constitutional, gastrointestinal (GI), and musculoskeletal involvement (components of SLAM-R), and decreased musculoskeletal (MSK) and central nervous system involvement (SLEDAI). Improvement reported by patients was most strongly associated with decreases in erythrocyte sedimentation rate and MSK and reticuloendothelial activity (SLAM-R), and in MSK activity (SLEDAI). Increased integument and MSK subscores (SLAM-R) and serosal and MSK subscores (SLEDAI) were associated with overall deterioration reported by physicians. Patient-reported deterioration was associated with increased GI subscores (SLAM-R) and with no changes in organ system involvement in SLEDAI. CONCLUSION: Organ systems associated with reported change in overall SLE activity differed between SLAM-R and SLEDAI, between patients and physicians, and between each direction of change.

A multicenter, randomized, double-blind, placebo-controlled trial of adjuvant methotrexate treatment for giant cell arteritis.

OBJECTIVE: To evaluate treatment with methotrexate (MTX) in patients with newly diagnosed giant cell arteritis (GCA) to determine if MTX reduces GCA relapses and cumulative corticosteroid (CS) requirements and diminishes disease- and treatment-related morbidity. METHODS: This was a multicenter, randomized, double-blind study. Over 4 years, 16 centers from the International Network for the Study of Systemic Vasculitides enrolled patients with unequivocal GCA. The initial treatment was 1 mg/kg/day (

Comparison of the responsiveness of lupus disease activity measures to changes in systemic lupus erythematosus activity relevant to patients and physicians.

Both the revised Systemic Lupus Activity Measure (SLAM-R) and the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) are valid and reliable measures of disease activity in systemic lupus erythematosus (SLE). However, more study of their responsiveness is needed. The purpose of this study was to compare the responsiveness of SLAM-R and SLEDAI to disease activity changes relevant to physicians and patients. Patients were evaluated monthly for up to 12 months. At each visit, the physician completed SLAM-R and SLEDAI. Patients and physicians assessed whether relevant improvement or worsening of disease activity had occurred since the previous visit. Based on repeated measurements, effect size (ES), standardized response mean (SRM), and control-standardized response mean (CSRM) were calculated for each response category, with bootstrap-based 95% confidence intervals (CIs). Seventy-six patients contributed 471 score changes. For physicians' responses, the CSRMs for SLAM-R and SLEDAI were -0.47 versus -0.42 for improvement, 0.04 versus 0.003 for no change, and 0.65 versus 0.66 for deterioration. For patients, the CSRMs for SLAM-R and SLEDAI were -0.31 versus -0.18 for improvement, -0.08 versus 0.06 for no change, and 0.48 versus 0.05 for deterioration. Only for SLAM-R did the 95% CIs exclude zero when improvement or deterioration were detected. Similar results were found for ES and SRM. Both SLAM-R and SLEDAI are responsive to changes in SLE disease activity important to physicians. Only SLAM-R is responsive to changes important to patients. These differences may result from the inclusion of subjective SLE manifestations in SLAM-R.