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1.
Osteoarthritis Cartilage ; 14(11): 1111-8, 2006 Nov.
Article in English | MEDLINE | ID: mdl-16784879

ABSTRACT

BACKGROUND: Osteoarthritis (OA) is frequently treated only during periods of flare, in which rapid onset of analgesia is the outcome target. OBJECTIVE: To assess an acute pain model of knee OA in flare. METHODS: In a multicenter, randomized, double-blind, controlled study, 530 patients aged >or=50 years received valdecoxib 10 mg qd (n=212), rofecoxib 2 5 mg qd (n=208), or placebo (n=110). Pain intensity (PI) was measured on a visual analog scale (VAS) at baseline after a 10-min walk. Patients took their first dose of study medication, rested for 20 min, then measured their PI VAS at 0.5, 1, 1.5, 2, 3, 4, 5, and 6h, each time following a 10-min walk. RESULTS: PI VAS differences (PID) were significantly greater vs placebo both with valdecoxib and rofecoxib (P<0.05) beginning as early as 3h (intent-to-treat population). The percentage of patients with analgesia onset from 4h was significantly higher with both valdecoxib (55%) and rofecoxib (56%) relative to placebo (40%). Median time to first onset of analgesic was shorter with both valdecoxib and rofecoxib compared with placebo (P=0.104 vs valdecoxib; P=0.036 vs rofecoxib). CONCLUSIONS: This acute pain model of knee OA flare detected significant pain relief with agents known to relieve pain in OA and placebo within hours after the first treatment dose, allowing assessment of pain relief within hours rather than days or weeks when evaluating analgesic efficacy in OA. This model is undergoing further study to determine optimal walk times, distances, and rates to maximize its sensitivity.


Subject(s)
Cyclooxygenase Inhibitors/therapeutic use , Osteoarthritis, Knee/drug therapy , Pain Measurement/methods , Acute Disease , Aged , Aged, 80 and over , Cyclooxygenase 2 Inhibitors/adverse effects , Cyclooxygenase 2 Inhibitors/therapeutic use , Cyclooxygenase Inhibitors/adverse effects , Double-Blind Method , Female , Humans , Isoxazoles/adverse effects , Isoxazoles/therapeutic use , Lactones/adverse effects , Lactones/therapeutic use , Male , Middle Aged , Models, Biological , Osteoarthritis, Knee/physiopathology , Severity of Illness Index , Sulfonamides/adverse effects , Sulfonamides/therapeutic use , Sulfones/adverse effects , Sulfones/therapeutic use , Time Factors , Treatment Outcome , Walking/physiology
3.
N Engl J Med ; 342(11): 763-9, 2000 Mar 16.
Article in English | MEDLINE | ID: mdl-10717011

ABSTRACT

BACKGROUND: We evaluated the safety and efficacy of etanercept, a soluble tumor necrosis factor receptor (p75):Fc fusion protein, in children with polyarticular juvenile rheumatoid arthritis who did not tolerate or had an inadequate response to methotrexate. METHODS: Patients 4 to 17 years old received 0.4 mg of etanercept per kilogram of body weight subcutaneously twice weekly for up to three months in the initial, open-label part of a multicenter trial. Those who responded to treatment then entered a double-blind study and were randomly assigned to receive either placebo or etanercept for four months or until a flare of the disease occurred. A response was defined as an improvement of 30 percent or more in at least three of six indicators of disease activity, with no more than one indicator worsening by more than 30 percent. RESULTS: At the end of the open-label study, 51 of the 69 patients (74 percent) had had responses to etanercept treatment. In the double-blind study, 21 of the 26 patients who received placebo (81 percent) withdrew because of disease flare, as compared with 7 of the 25 patients who received etanercept (28 percent) (P=0.003). The median time to disease flare with placebo was 28 days, as compared with more than 116 days with etanercept (P<0.001). In the double-blind study, there were no significant differences between the two treatment groups in the frequency of adverse events. CONCLUSIONS: Treatment with etanercept leads to significant improvement in patients with active polyarticular juvenile rheumatoid arthritis. Etanercept is well tolerated by pediatric patients.


Subject(s)
Antirheumatic Agents/therapeutic use , Arthritis, Juvenile/drug therapy , Immunoglobulin G/therapeutic use , Receptors, Tumor Necrosis Factor/therapeutic use , Activities of Daily Living , Adolescent , Antirheumatic Agents/adverse effects , Arthritis, Juvenile/physiopathology , Child , Child, Preschool , Double-Blind Method , Etanercept , Female , Humans , Immunoglobulin G/adverse effects , Immunoglobulin G/analysis , Male , Receptors, Tumor Necrosis Factor/analysis
4.
J Pediatr ; 135(4): 500-5, 1999 Oct.
Article in English | MEDLINE | ID: mdl-10518085

ABSTRACT

OBJECTIVE: To describe the diversity in presenting manifestations of systemic lupus erythematosus (SLE) in children. STUDY DESIGN: Initial clinical and laboratory manifestations of 39 children, who fulfilled >/=4 American College of Rheumatology criteria for SLE, were retrospectively analyzed. RESULTS: Median age at onset was 12 years. The male to female ratio was 1:18.5, and racial/ethnic backgrounds were white 41%, black 33%, and Hispanic 26%. Initial manifestations included musculoskeletal 74%, cutaneous 72%, constitutional 67%, neurologic 28%, renal 28%, lymphadenopathy 15%, and Raynaud's phenomenon 10%. Laboratory abnormalities at presentation to our clinic included elevated erythrocyte sedimentation rate 87%, anemia 72%, lymphopenia 59%, leukopenia 31%, proteinuria or cellular casts 44%, low C(3) or C(4) level 77%, antinuclear antibodies 97%, and anti-double-stranded DNA 95%. One third (33%) presented with features not initially suggestive of SLE. Six patients presented with unusual manifestations including parotitis, quadriplegia, chorea, severe abdominal pain, persistent cough, and dizziness. However, 85% of patients with atypical manifestations had abnormal complete blood count or urinalysis results at presentation. CONCLUSION: Presenting manifestations of SLE in children are diverse. A detailed history, thorough review of systems, complete physical examination, complete blood count, urinalysis, and a high index of suspicion help to make the correct diagnosis of SLE in patients with atypical presentations.


Subject(s)
Lupus Erythematosus, Systemic/diagnosis , Adolescent , Child , Child, Preschool , Female , Humans , Lupus Erythematosus, Systemic/complications , Male , Retrospective Studies
5.
Chest ; 115(5): 1471-3, 1999 May.
Article in English | MEDLINE | ID: mdl-10334177

ABSTRACT

Minoeycline, a semisynthetic tetracycline, is often used to treat acne and rheumatoid arthritis. It has been considered an unlikely drug to be associated with systemic lupus erythematosus; however, many cases of drug-induced lupus related to minocycline have been reported. Some of those reports included pulmonary lupus, but none of the patients described developed respiratory distress. We describe a patient treated with minocycline for 2 years who presented with progressive dyspnea, severe hypoxia, and pulmonary infiltrates necessitating hospitalization and oxygen supplementation.


Subject(s)
Anti-Bacterial Agents/adverse effects , Lung Diseases/chemically induced , Lupus Erythematosus, Systemic/chemically induced , Minocycline/adverse effects , Respiratory Insufficiency/chemically induced , Adolescent , Female , Humans , Lung/diagnostic imaging , Lung Diseases/diagnostic imaging , Lupus Erythematosus, Systemic/diagnostic imaging , Radiography
6.
Arthritis Rheum ; 40(11): 1967-75, 1997 Nov.
Article in English | MEDLINE | ID: mdl-9365085

ABSTRACT

OBJECTIVE: To determine the extent of significant osteopenia in prepubertal patients with juvenile rheumatoid arthritis (JRA) not treated with corticosteroids and to identify variables that are highly related to bone mineralization in this population. METHODS: In a cross-sectional study, 48 JRA patients and 25 healthy control subjects ages 4.6-11.0 years were evaluated. Total body bone mineral density (TB BMD) was determined by Hologic dual energy x-ray absorptiometry. All patients were prepubertal (Tanner stage I or II) and had never taken corticosteroids. For comparison, JRA patients were divided into "low" TB BMD (Z score < or =-1) or "normal" TB BMD (Z score >-1). RESULTS: The overall mean +/- SD TB BMD scores did not differ between the JRA subjects (0.75 +/- 0.06 gm/cm2) and controls (0.73 +/- 0.07 gm/cm2; P > 0.30). However, 29.2% of the JRA patients had low TB BMD, whereas only 16% would be expected to have low TB BMD based on the standard normal distribution (goodness of fit chi(2) = 4.84, P = 0.01). The mean Z score for the JRA patients with low TB BMD was -1.43, and for those with normal TB BMD, it was 0.32. The JRA subjects with low TB BMD were significantly younger, had more active articular disease, greater physical function limitation, higher erythrocyte sedimentation rate, higher joint count severity score, lower body mass index, lower lean body mass, less participation in organized sports, and more protein and vitamin D in their diet compared with JRA patients with normal TB BMD (all P < 0.05). Using logistic regression, a model including age at JRA onset, Juvenile Arthritis Functional Assessment Report (JAFAR) score, triceps skin-fold percentiles, percentage US recommended daily allowance for dietary magnesium intake, and serum 1,25-dihydroxyvitamin D levels was able to accurately segregate 79.6% of the JRA subjects into either the low or normal TB BMD groups (chi(2) = 20.5, P = 0.001). CONCLUSION: This study demonstrated that in a mildly to moderately ill prepubertal JRA population that had never been exposed to corticosteroids, almost 30% had significantly low TB BMD. The patients with low TB BMD had more active and severe articular disease and greater physical function limitation. Disease-related parameters in JRA appear to exert a negative effect on bone mineralization even in prepubertal children, which can be demonstrated despite the exclusion of corticosteroid-treated patients.


Subject(s)
Arthritis, Juvenile/physiopathology , Bone Density/physiology , Adrenal Cortex Hormones/therapeutic use , Anthropometry , Arthritis, Juvenile/blood , Arthritis, Juvenile/drug therapy , Bone Density/drug effects , Child , Child, Preschool , Cytokines/blood , Female , Humans , Magnesium/blood , Male , Phosphorus/blood , Puberty/physiology , Regression Analysis
7.
Pediatr Clin North Am ; 42(5): 1099-125, 1995 Oct.
Article in English | MEDLINE | ID: mdl-7567188

ABSTRACT

Rheumatology made its debut as a legitimate subspecialty of pediatrics sometime in the 1940s in Europe, and in the 1970s in North America. Therapy of juvenile rheumatoid arthritis has evolved from salicylates and gold injections to newer, less toxic nonsteroidal anti-inflammatory drugs and methotrexate. Corticosteroids remain as important drugs when life-threatening complications or blinding iridocyclitis develop. Immune response modifiers and gene therapies offer considerable potential for eventually halting or curing the disease but have yet to make a substantial impact on therapy. Methods for the correct conduct and interpretation of data from clinical trials are discussed.


Subject(s)
Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Antirheumatic Agents/therapeutic use , Arthritis, Juvenile/drug therapy , Anti-Inflammatory Agents, Non-Steroidal/history , Antirheumatic Agents/history , Arthritis, Juvenile/history , Arthritis, Juvenile/therapy , Child , Genetic Therapy , History, 20th Century , Humans , Rheumatology/history
8.
J Rheumatol ; 21(12): 2353-8, 1994 Dec.
Article in English | MEDLINE | ID: mdl-7699642

ABSTRACT

OBJECTIVE: To assess the efficacy and safety of intravenous immunoglobulin (IVIG) in juvenile rheumatoid arthritis (JRA). METHODS: Thirty-one children with active, refractory, systemic JRA were randomized into a multicentered, double blinded, placebo controlled trial. Patients received infusions of 1.5 g/kg of IVIG or placebo (0.1% albumin) every 2 weeks for 2 months, then monthly for 4 months (total: up to 9 infusions over 6 months). Twenty-nine of the 31 patients were included in the efficacy subset. RESULTS: Fourteen patients discontinued prematurely from study, 7 in each treatment group. A higher proportion of patients in the IVIG group improved (50 vs 27%) as assessed by the physician's global assessment. However, the sample size was small and this difference was not statistically significant. IVIG was not more effective than placebo in reducing the number of days with fever or other systemic manifestations. Changes from baseline in the joint count, hemoglobin, albumin, platelet count, and erythrocyte sedimentation rate did not differ between treatment groups. CONCLUSION: Our results suggest that high dose IVIG has limited clinical utility in systemic JRA. However, this trial failed to enroll adequate numbers of patients to permit valid statistical intergroup comparisons, and the results must be considered nondefinitive.


Subject(s)
Arthritis, Juvenile/therapy , Immunoglobulins, Intravenous/therapeutic use , Adolescent , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Antirheumatic Agents/therapeutic use , Arthritis, Juvenile/drug therapy , Child , Child, Preschool , Double-Blind Method , Drug Therapy, Combination , Female , Humans , Immunoglobulins, Intravenous/administration & dosage , Immunoglobulins, Intravenous/adverse effects , Infant , Male
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