Ultrasound-guided synovial biopsy (UGSB) is a minimally-invasive procedure capable of retrieving good quality tissue from small and large joints. The use of UGSB in prospective clinical trials poses ...a dilemma as to whether biopsied joints may be later included in core data sets for clinical or imagining response, as the procedure itself may alter disease activity assessment. In this study, we examine the impact of UGSB of the wrist on subsequent clinical and ultrasound (US) assessments in a cohort of rheumatoid arthritis (RA) patients prior to initiation of anti-TNF-alpha therapy.
Patients had active disease (DAS>5.1) involving their wrist. Both wrists were scanned and the most inflamed one underwent an UGSB. Ultrasonographic and clinical assessments were repeated at the patients' subsequent visit, without any changes in disease-modifying treatment between visits. US images were scored semi-quantitatively and quantitatively for synovial thickness (ST) and power Doppler (PD). Mixed-effects model and paired-Wilcoxon signed rank test were used to assess the effect of UGSB on these scores.
Twenty-nine patients were enrolled. No significant difference in mean ST (p=0.32) or PD (p=0.21) was demonstrated pre- and post-biopsy (mean time 14.7 days). Similar results were obtained using quantitative measures. The DAS-28 and its components did not change significantly post-biopsy.
In this population, UGSB of the wrist did not significantly alter subsequent clinical or US assessments, indicating that a wrist joint, which has undergone UGSB, may be incorporated into an US dataset or clinical outcome assessment tools, such as the DAS-28, without prejudice.
BackgroundIn SLE, musculoskeletal manifestations have an impact on quality of life, disability and clinical trial outcomes, but are harder to assess than in RA and PsA. We previously showed that ...joint swelling lacks sensitivity, specificity and responsiveness compared to ultrasound. USEFUL was a multicentre longitudinal study to determine clinical features predicting ultrasound synovitis and whether patients with ultrasound synovitis respond better to therapy.MethodsSLE patients were recruited if the referring physician deemed they had inflammatory pain warranting treatment. Swollen joints were not required. At baseline, physicians recorded the features that led them to diagnose inflammatory pain and features of concurrent fibromyalgia and osteoarthritis. Stable doses of prednisolone (≤5 mg/day), antimalarials or immunosuppressants were allowed. Participants received depomedrone 120 mg IM then were assessed at 0, 2 and 6 weeks for 66/68 swollen and tender joint counts, BILAG-2004, SLEDAI-2K, physician global and MSK-VAS, inflammatory markers, patient pain and disease activity-VAS, HAQ-DI, LupusQoL, ultrasound of hands and wrists (blinded to patient and clinical assessor). An internal pilot determined the primary endpoint: EMS-VAS at 2 weeks (adjusted for baseline) between patients with ultrasound-synovitis vs. normal ultrasound at baseline. Sensitivity analyses adjusted for prednisolone and immunosuppressants.Results122/133 patients recruited completed all visits. There was significant disagreement between clinical examination and ultrasound. 78/133 had ultrasound synovitis; 68% of these had ≥1 swollen joint. Of 66/133 patients with ≥ 1 swollen joint, 20% had normal ultrasound.Ultrasound-synovitis was more likely with joint swelling, a symmetrical small joint distribution and active serology. Physician-determined EMS, other lupus features or prior response to therapy were not associated. Fibromyalgia or osteoarthritis did not reduce the probability of ultrasound synovitis.In the full analysis set (n=133) there was no difference in EMS VAS at 2 weeks according to ultrasound synovial status as baseline (difference -8 mm, 95% CI -19, 4 mm, p=0.178). 32 patients had fibromyalgia. After excluding these patients, we found a statistically and clinically significantly better clinical response to depomedrone in patients with ultrasound-synovitis at baseline (baseline-adjusted EMS VAS at 2 weeks -12 mm, 95% CI -24, 0 mm, p=0.049). This difference was greater in the treatment-adjusted sensitivity analysis (-12.8 (95% CI -22, -3 mm), p=0.007) and the per-protocol-adjusted sensitivity analysis (-14.8 mm (95% CI -20.8, -8.8 mm), p<0.001). Patient with ultrasound synovitis had higher rates of improvement in the musculoskeletal BILAG-2004 (56% vs. 26%, p=0.09) and SLEDAI-2K (37% vs. 15%, p=0.03).ConclusionsIn lupus arthritis distribution and serology, but not other features, help identify ultrasound-synovitis. Ultrasound-synovitis was independent of features of fibromyalgia, but fibromyalgia confounded assessment of response. Excluding fibromyalgia, response to therapy was better in patients with abnormal ultrasound compared to normal. Ultrasound should be used to select patients for therapy and clinical trials, especially when there are inflammatory symptoms without swollen joints.AcknowledgementsThis project was funded by a grant from Lupus UK.
Objective Develop and apply new costing methodologies to estimate costs of opioid dependence treatment in countries worldwide. Data Sources/Study Setting Micro‐costing methodology developed and data ...collected during randomized controlled trial ( RCT ) involving 126 patients ( J uly 2003– M ay 2005) in M alaysia. Gross‐costing methodology developed to estimate costs of treatment replication in 32 countries with data collected from publicly available sources. Study Design Fixed, variable, and societal cost components of M alaysian RCT micro‐costed and analytical framework created and employed for gross‐costing in 32 countries selected by three criteria relative to M alaysia: major heroin problem, geographic proximity, and comparable gross domestic product (GDP) per capita. Principal Findings Medication, and urine and blood testing accounted for the greatest percentage of total costs for both naltrexone (29–53 percent) and buprenorphine (33–72 percent) interventions. In 13 countries, buprenorphine treatment could be provided for under $2,000 per patient. For all countries except U nited K ingdom and S ingapore, incremental costs per person were below $1,000 when comparing buprenorphine to naltrexone. An estimated 100 percent of opiate users in C ambodia and L ao P eople's D emocratic R epublic could be treated for $8 and $30 million, respectively. Conclusions Buprenorphine treatment can be provided at low cost in countries across the world. This study's new costing methodologies provide tools for health systems worldwide to determine the feasibility and cost of similar interventions.
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Available for:
BFBNIB, DOBA, FZAB, GIS, IJS, IZUM, KILJ, NLZOH, NUK, OILJ, PILJ, PNG, SAZU, SBCE, SBMB, SIK, UILJ, UKNU, UL, UM, UPUK
Abstract
Background
In SLE, musculoskeletal manifestations have an impact on quality of life, disability and clinical trial outcomes, but are harder to assess than in RA and PsA. We previously showed ...that joint swelling lacks sensitivity, specificity and responsiveness compared to ultrasound. USEFUL was a multicentre longitudinal study to determine clinical features predicting ultrasound synovitis and whether patients with ultrasound synovitis respond better to therapy.
Methods
SLE patients were recruited if the referring physician deemed that they had inflammatory pain warranting treatment. Swollen joints were not required. At baseline, physicians recorded the features that led them to diagnose inflammatory pain and features of concurrent fibromyalgia and osteoarthritis. Stable doses of prednisolone (≤5mg/day), antimalarials or immunosuppressants were allowed. Participants received depomedrone 120mg IM then were assessed at 0, 2 and 6 weeks for 66/68 swollen and tender joint counts, BILAG-2004, SLEDAI-2K, physician global and MSK-VAS, inflammatory markers, patient pain and disease activity-VAS, HAQ-DI, LupusQoL, ultrasound of hands and wrists (blinded to patient and clinical assessor). An internal pilot determined the primary endpoint: EMS-VAS at 2 weeks (adjusted for baseline) between patients with ultrasound-synovitis vs. normal ultrasound at baseline. Sensitivity analyses adjusted for prednisolone and immunosuppressants.
Results
122/133 patients recruited completed all visits. There was significant disagreement between clinical examination and ultrasound. 78/133 had ultrasound synovitis; 68% of these had > =1 swollen joint. Of 66/133 patients with > = 1 swollen joint, 20% had normal ultrasound. Ultrasound-synovitis was more likely with joint swelling, a symmetrical small joint distribution and active serology. Physician-determined EMS, other lupus features or prior response to therapy were not associated. Fibromyalgia or osteoarthritis did not reduce the probability of ultrasound synovitis. In the full analysis set (n = 133) there was no difference in EMS VAS at 2 weeks according to ultrasound synovial status as baseline (difference -8mm, 95% CI -19, 4mm, p = 0.178). 32 patients had fibromyalgia. After excluding these patients, we found a statistically and clinically significantly better clinical response to depomedrone in patients with ultrasound-synovitis at baseline (baseline-adjusted EMS VAS at 2 weeks -12mm, 95% CI -24, 0mm, p = 0.049). This difference was greater in the treatment-adjusted sensitivity analysis (-12.8 (95% CI -22, -3mm), p = 0.007) and the per-protocol-adjusted sensitivity analysis (-14.8mm (95% CI -20.8, -8.8mm), p < 0.001). Patients with ultrasound synovitis had higher rates of improvement in the musculoskeletal BILAG-2004 (56% vs. 26%, p = 0.09) and SLEDAI-2K (37% vs. 15%, p = 0.03).
Conclusion
In lupus arthritis distribution and serology, but not other features, help identify ultrasound-synovitis. Ultrasound-synovitis was independent of features of fibromyalgia, but fibromyalgia confounded assessment of response. Excluding fibromyalgia, response to therapy was better in patients with abnormal ultrasound compared to normal. Ultrasound should be used to select patients for therapy and clinical trials, especially when there are inflammatory symptoms without swollen joints.
Disclosures
K. Mahmoud None. A. Zayat None. M. Md Yusof None. K.1. Dutton None. L. Teh None. C. Yee None. D. D'Cruz None. N. Ng None. D. Isenberg None. C. Ciurtin None. P. Conaghan None. P. Emery None. C. Edwards None. E. Hensor None. E.M. Vital Honoraria; AstraZeneca, GSK, Lilly.
Case Reports [3–24] Seiber, Clare; Bawa, Sandeep; Ritchie, David ...
Rheumatology (Oxford, England),
04/2010, Volume:
49, Issue:
suppl-1
Journal Article
Peer reviewed
Background: Focal myositis is a benign inflammatory pseudotumour of skeletal muscle, that usually presents in the extremities. We present what we believe is the first published case of a patient with ...a focal myositis of the pectoral region. Methods: A previously fit and well 34 year old Caucasian gentleman presented with a 3-month history of a progressively enlarging painful mass in the right pectoral region. He denied any trauma, prior masses, muscle dysfunction, symptoms of connective tissue disease, fever, rashes, acne or pustulosis. Clinical examination revealed a palpable, tender soft tissue mass measuring 4 cm x 5 cm, antero-inferior to the right sternoclavicular joint. There was no evidence of synovitis and the overlying skin was normal in appearance. The patient displayed normal muscle power and had no cervical or axillary lymphadenopathy. Investigations revealed ESR 43 mm/h (normal range < 20 mm/h), CRP 30mg/l (normal range < 10 mg/l), CK 85 U/l (normal range 24–195 U/l). Blood chemistry, bone profile, antinuclear antibodies, ENA, dsDNA, RF, immunoelectrophoresis, hepatitis serology, CMV and EBV were all negative. Chest X-ray was normal. A T2 weighted MRI of the thorax identified an area of oedema within the upper right pectoral muscle. The sternoclavicular and manubrio-sternal joints were not affected. A muscle biopsy demonstrated skeletal muscle with an eosinophilic inflammatory infiltrate, consistent with a diagnosis of focal myositis. Malignancy and TB were excluded. Results: The patient commenced prednisolone 20 mg daily. Upon review, the mass had clinically resolved and the patient was asymptomatic. The dose of steroid was then tapered over 4 months. Methotrexate 12.5 mg once weekly was initiated due to the reoccurrence of symptoms on lower doses of prednisolone. Conclusions: Focal myositis was first identified as a distinct clinicopathologic entity by Heffner et al. in 19771. In the 16 reported cases by the authors, myositis occurred in the limbs. Cases have subsequently been reported in the abdomen, head and neck. Focal myositis has no age or sex predilection and most patients deny any weakness or systemic symptoms. Clinically it can mimic the features of a soft tissue sarcoma. It may be mistaken for early manifestations of polymyositis or connective tissue disease. The aetiology is unknown. Trauma has rarely been identified as a precipitating factor. A viral mechanism has been suggested but no organism has been identified. Focal myositis has an excellent prognosis, with a high rate of spontaneous regression without recurrence. It can be treated effectively with glucocorticoids due to the inflammatory nature of the condition. We report to the best of our knowledge the first case described in the literature of a focal myositis in the pectoral muscle. Although focal myositis is a rare condition, it should be considered as a differential diagnosis for a mass presenting in any skeletal muscle group. Disclosure statement: All authors have declared no conflicts of interest.