Clinical rheumatology
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Clinical rheumatology · Jan 2017
Randomized Controlled Trial Multicenter StudyEfficacy of tofacitinib in patients with rheumatoid arthritis stratified by background methotrexate dose group.
Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). This post hoc analysis investigated the effect of methotrexate (MTX) dose on the efficacy of tofacitinib in patients with RA. ORAL Scan (NCT00847613) was a 2-year, randomized, Phase 3 trial evaluating tofacitinib in MTX-inadequate responder (IR) patients with RA. ⋯ At month 3, mean changes from baseline in CDAI and HAQ-DI were significantly greater for both tofacitinib doses vs placebo, irrespective of MTX category; improvements were maintained at month 6. Both tofacitinib doses demonstrated improvements in DAS28-4(ESR), and less structural progression vs placebo, across MTX doses at month 6. Tofacitinib plus MTX showed greater clinical and radiographic efficacy than placebo in MTX-IR patients with RA, regardless of MTX dose.
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Clinical rheumatology · Aug 2016
Multicenter StudyTendon involvement in patients with gout: an ultrasound study of prevalence.
The objective of the present study is to evaluate, by ultrasonography (US), the prevalence in the quadriceps, patellar, and Achilles tendon involvement of gout compared to that of patients with osteoarthritis and asymptomatic marathon runners. This is a multicenter, multinational, transverse cross-sectional, and comparative study comprising 80 patients with the diagnosis of gout according to the American College of Rheumatology (ACR) criteria, compared with two control groups: 35 patients with generalized osteoarthritis according to the ACR criteria and 35 subjects who were healthy marathon runners. Demographics and clinical characteristics, such as age, gender, comorbidity, disease duration, pain at the enthesis in the knee and ankle, frequency of disease exacerbations, uric acid level more than 7.2 mg at the time of evaluation, and type of treatment, were recorded. ⋯ In patients with osteoarthritis (OA), intra-tendinous hyperechoic aggregates were observed in 20 % of quadriceps tendons and in 11 % of patellar tendons at its proximal insertion, while in the healthy marathon runner group, the Achilles tendon had this kind of lesion in 17 % of the subjects. Neither the OA nor the healthy marathon runners had intra-tendinous tophi. The sensitivity and specificity of US to detect tophi or aggregates were 69.6 and 92 %, respectively, tendon involvement at the lower limbs in gout is very frequent, particularly in the patellar tendon, and US possesses good sensitivity and specificity for detecting intra-tendinous tophi.
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Clinical rheumatology · Jan 2013
Randomized Controlled Trial Multicenter StudyA multicenter, randomized, double-blind clinical trial of combination therapy with Anbainuo, a novel recombinant human TNFRII:Fc fusion protein, plus methotrexate versus methotrexate alone or Anbainuo alone in Chinese patients with moderate to severe rheumatoid arthritis.
This study aims to evaluate the clinical and radiological efficacy as well as safety profiles of Anbainuo, a recombinant human TNFRII:Fc fusion protein, combined with methotrexate (MTX) versus MTX alone or Anbainuo alone in the treatment of Chinese patients with moderate to severe rheumatoid arthritis (RA). In this 24-week, multicenter, double-blind, active comparator-controlled study, 396 RA patients were randomized into combination therapy group (Anbainuo plus MTX), Anbainuo group, or MTX group. Clinical response was assessed using the American College of Rheumatology (ACR)-N, ACR20, ACR50, ACR70, and van der Heijde modification of Sharp score, among which ACR-N and ACR20 were defined as primary major endpoints. ⋯ The combination therapy group also showed significantly less radiographic progression than the MTX group (p = 0.03). The total adverse events (AE) in the combination group (40.9 %) was significantly higher than those in the MTX group (28.8 %) (p < 0.05). Anbainuo combined with MTX therapy can effectively control the disease activity and radiographic progression of RA, while the incidence of AE also increased compared to either Anbainuo or MTX.
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Clinical rheumatology · Feb 2012
Randomized Controlled Trial Multicenter Study Comparative StudyThe efficacy of tramadol/acetaminophen combination tablets (Ultracet®) as add-on and maintenance therapy in knee osteoarthritis pain inadequately controlled by nonsteroidal anti-inflammatory drug (NSAID).
The purpose of this study is to compare the efficacy of tramadol 37.5 mg/acetaminophen 325 mg combination tablets (tramadol/APAP) with that of nonsteroidal anti-inflammatory drugs (NSAIDs) as maintenance therapy following tramadol/APAP and NSAID combination therapy in knee osteoarthritis (OA) pain which was inadequately controlled by NSAIDs. Subjects with knee OA for over 1 year and moderate pain (numerical rating scale [NRS] ≥5) despite at least 4 weeks' NSAID therapy (meloxicam 7.5 mg or 15 mg qd or aceclofenac 100 mg bid) received tramadol/APAP add-on (combination with NSAID) for 4 weeks. Thereafter, subjects with significant pain improvement (NRS <4) were randomized to receive either tramadol/APAP or NSAID for 8 weeks. ⋯ Overall adverse event rates were similar in both groups. Tramadol/APAP add-on significantly improved knee OA pain which had been inadequately controlled by NSAIDs. In those subjects who showed favorable response to tramadol/APAP and NSAID combination therapy, both tramadol/APAP and NSAIDs were effective at maintaining the pain-reduced state and there was no significant difference in efficacy between tramadol/APAP and NSAIDs.
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Clinical rheumatology · Jan 2012
Multicenter Study Clinical TrialSafety and acceptability of suprascapular nerve block in rheumatology patients.
Suprascapular nerve block (SSNB) is a popular treatment for shoulder pain. To date, studies undertaken mainly describe the methods of performing the technique or are trials examining its efficacy. As a result, the numbers of blocks reported are small and therefore confidence in the safety of the procedure must be limited. ⋯ Patient satisfaction with the pain relief was high, with over 80% of respondents being satisfied or very satisfied with the result. SSNB is a very safe procedure in the outpatient setting, even among frail, elderly patients. Patients rate the satisfaction with the pain relief highly.