Abstract:
BACKGROUND:Rates and impacts of worsening symptoms in patients with psoriasis have not been well characterized. OBJECTIVES:To assess the risk of clinically relevant worsening of psoriasis symptoms in patients treated with adalimumab versus placebo and to determine the health-related quality-of-life (HRQOL) impacts of such worsening. METHODS:The cumulative incidence of worsening was compared for adalimumab (40 mg every other week following an 80 mg induction dose) versus placebo using data from two phase III randomized, placebo-controlled trials (CHAMPION and REVEAL). Clinically relevant worsening of psoriasis was defined as a follow-up visit with a ≥25% increase in the Psoriasis Area and Severity Index (PASI) from baseline or a ≥5-unit increase in the Dermatology Life Quality Index from baseline during the initial 16-week double-blind treatment periods. Patients with versus without worsening were compared in terms of pain, work productivity and activity impairment (WPAI) and the mental and physical component summary (MCS and PCS) scores of the Short-Form 36 Health Survey. A subgroup analysis was performed for patients with PASI 10-20 at baseline. RESULTS:The 17-week risk of clinically relevant worsening was 37.0% (95% CI 26.1, 46.3) for placebo (n = 445) and 4.2% (95% CI 2.0, 6.3) for adalimumab-treated patients (n = 914) [p < 0.0001]. Patients with versus without worsening experienced substantially increased pain, increased WPAI and greater impairment in MCS and PCS. Results were similar for patients with PASI 10-20 at baseline. LIMITATIONS:The short study duration may not reflect long-term outcomes. CONCLUSION:Clinically relevant worsening of psoriasis symptoms was associated with substantial worsening of HRQOL. Adalimumab treatment was associated with a substantially reduced risk of clinically relevant worsening.
journal_name
Clin Drug Investigjournal_title
Clinical drug investigationauthors
Papp KA,Signorovitch J,Ramakrishnan K,Yu AP,Gupta SR,Bao Y,Mulani PMdoi
10.2165/11539360-000000000-00000subject
Has Abstractpub_date
2011-01-01 00:00:00pages
51-60issue
1eissn
1173-2563issn
1179-1918journal_volume
31pub_type
杂志文章abstract:BACKGROUND:NSAIDs are widely used for patients presenting with low back pain. A quick-release formulation of lornoxicam, a potent NSAID from the chemical class of oxicams, offers a faster onset of pain relief compared with the standard tablet formulation. METHODS:Time to onset of pain relief with lornoxicam was compar...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.2165/00044011-200626050-00004
更新日期:2006-01-01 00:00:00
abstract::Early initiation of rational and effective combination therapy consisting of antihypertensive drugs with two different and complementary mechanisms of actions is increasingly becoming accepted in clinical practice and by guidelines as a first-line approach to control blood pressure (BP) and prevent cardiovascular outc...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.2165/11538440-000000000-00000
更新日期:2010-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Several cases of facial paralysis have been reported following influenza vaccination; however, recent surveillance studies have not shown an increased risk. In this study, we analyzed the vaccine adverse event reporting system (VAERS) data to determine whether the facial paralysis reporting rat...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-020-00952-0
更新日期:2020-09-01 00:00:00
abstract:BACKGROUND:The Benign Prostatic Hyperplasia-Patient Impact Measure (BPH-PIM) is a self-reported quality-of-life questionnaire for measuring the impact of urinary/prostate symptoms on the quality of life of patients with BPH. The aim of the present study was to adapt the original instrument to Spanish (for use in Spain)...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200626020-00005
更新日期:2006-01-01 00:00:00
abstract:BACKGROUND:Overactive bladder is a prevalent condition worldwide that is associated with a considerable burden, both on the patient and on society. OBJECTIVE:Our objective was to assess the economic value of fesoterodine compared with tolterodine extended release (ER) for the treatment of overactive bladder (OAB) with...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.1007/s40261-014-0178-1
更新日期:2014-05-01 00:00:00
abstract:OBJECTIVE:To compare the real-life treatment of acute exacerbations of chronic bronchitis (AECBs) using moxifloxacin tablets or one of the oral macrolides azithromycin, clarithromycin or roxithromycin in terms of symptom relief, time until improvement and cure, overall efficacy and tolerability. METHODS:This prospecti...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究
doi:10.2165/00044011-200626120-00007
更新日期:2006-01-01 00:00:00
abstract:BACKGROUND:Among the many consequences of loss of CFTR protein function, a significant reduction of the secretion of bicarbonate (HCO3-) in cystic fibrosis (CF) is a major pathogenic feature. Loss of HCO3- leads to abnormally low pH and impaired mucus clearance in airways and other exocrine organs, which suggests that ...
journal_title:Clinical drug investigation
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doi:10.1007/s40261-019-00861-x
更新日期:2020-02-01 00:00:00
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journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.2165/00044011-200727050-00003
更新日期:2007-01-01 00:00:00
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journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究
doi:10.1007/s40261-017-0581-5
更新日期:2018-01-01 00:00:00
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journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200424060-00003
更新日期:2004-01-01 00:00:00
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journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.2165/00044011-200626110-00005
更新日期:2006-01-01 00:00:00
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journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.2165/0044011-200828120-00004
更新日期:2008-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Bilastine is a novel second-generation antihistamine for the symptomatic treatment of allergic rhinitis and urticaria. The objective of this study was to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of bilastine following single and multiple oral doses in healthy Japanese ...
journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-016-0447-2
更新日期:2016-12-01 00:00:00
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journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200323060-00003
更新日期:2003-01-01 00:00:00
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journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200525050-00005
更新日期:2005-01-01 00:00:00
abstract::Psychotropic medications and alcohol are potential risk factors for falls in older adults. However, there has been no appraisal of the literature on whether these medications, both singly and in combination with alcohol, are associated with falls in community dwelling older adults (those aged 60 years and older living...
journal_title:Clinical drug investigation
pub_type: 杂志文章,评审
doi:10.1007/s40261-018-0721-6
更新日期:2019-02-01 00:00:00
abstract::The efficacy and tolerability of fluticasone aqueous nasal spray, 200µg once daily for 21 days, was compared with cetirizine, 10mg once daily for 21 days, in a multicentre, randomised, double-blind, double-dummy, parallel group study. 237 evaluable patients aged 12 years and above, with seasonal allergic rhinitis (def...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-199713060-00001
更新日期:1997-06-01 00:00:00
abstract::Lung infections caused by invasive filamentous fungi are very rare conditions in AIDS, but must be considered in patients with profound immune suppression especially in the presence of additional risk factors, such as hematologic malignancies, corticosteroid therapy, neutropenia, and chemotherapy. The authors report a...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-012-0017-1
更新日期:2013-02-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Phenylephrine HCl 10 mg has been used as a nasal decongestant for over 50 years, yet only limited pharmacokinetic and metabolic data are available. The purpose of this study was to evaluate single-dose pharmacokinetics and safety of phenylephrine HCl 10, 20, and 30 mg and to assess cardiovascu...
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pub_type: 杂志文章,随机对照试验
doi:10.1007/s40261-015-0311-9
更新日期:2015-09-01 00:00:00
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doi:10.2165/0044011-200929010-00001
更新日期:2009-01-01 00:00:00
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journal_title:Clinical drug investigation
pub_type: 杂志文章,随机对照试验
doi:10.2165/11533420-000000000-00000
更新日期:2010-01-01 00:00:00
abstract:OBJECTIVE:The efficacy and tolerability of a new combination inhaler containing both salmeterol 50mg and fluticasone 100mg in a single device was compared with the delivery of the two drugs via two separate inhalers in a multicentre, double-blind, double-dummy study. PATIENTS:244 symptomatic asthma patients (age range...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-199816030-00003
更新日期:1998-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:The use of low levels of visible or near infrared light for reducing pain, inflammation and oedema, promoting healing of wounds, deeper tissue and nerves, and preventing tissue damage has been known for almost 40 years since the invention of lasers. The HairMax LaserComb is a hand-held Class 3R...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.2165/00044011-200929050-00001
更新日期:2009-01-01 00:00:00
abstract:BACKGROUND:Oral contraceptives (OCs) are one of the most commonly used classes of drugs worldwide. A case of neutropenia and associated infections in a young woman using OCs that settled after discontinuation and reappeared upon re-challenge, has led us to investigate a potential association between oral contraceptives...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-019-00818-0
更新日期:2019-10-01 00:00:00
abstract:BACKGROUND:Urinary tract infection (UTI) is a leading cause of morbidity in the female population, with high levels of prevalence and recurrence within 6 months. OBJECTIVES:Our objective was to estimate annual costs and health resource utilization by women with UTIs, and the impact on quality of life (QoL) due to lowe...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.1007/s40261-013-0069-x
更新日期:2013-04-01 00:00:00
abstract:BACKGROUND:Dutasteride is a dual inhibitor of type I and type II 5α-reductases and provides nearly complete suppression of dihydrotestosterone, which plays a key role in the aetiology and development of benign prostatic hyperplasia (BPH). Most knowledge about the efficacy and safety of dutasteride in BPH derives from t...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.2165/11593750-000000000-00000
更新日期:2012-01-01 00:00:00
abstract:BACKGROUND:Propofol is approved both for anaesthesia and sedation during intensive care. Serious adverse reactions with propofol have recently been reported, but patient exposure to the drug is unknown. OBJECTIVE:To investigate the consumption of propofol in Finnish hospitals and to develop a denominator to estimate p...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200323010-00003
更新日期:2003-01-01 00:00:00
abstract:OBJECTIVE:In this study, we evaluated the effectiveness of amlodipine in patients with severe ischaemic left ventricular dysfunction (LVD) and mild to moderate heart failure, but not current angina, assessing the effects of the drug on symptoms, left ventricular function and exercise capacity. PATIENTS AND METHODS:We ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-199816040-00003
更新日期:1998-01-01 00:00:00
abstract:OBJECTIVE:To compare the bioavailability of two 15mg ambroxol lozenges with a commercial 30mg ambroxol tablet. DESIGN:Open-label, two-way crossover study. METHOD:Each formulation was randomly administered to 20 healthy Thai volunteers (ten male and ten female) with a 1-week washout period between formulations. After ...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200323040-00007
更新日期:2003-01-01 00:00:00
abstract:BACKGROUND:To evaluate the efficacy and safety of bronchoalveolar lavage (BAL) with diluted porcine surfactant in mechanically ventilated term infants with severe acute respiratory distress syndrome (ARDS) due to meconium aspiration syndrome (MAS). METHODS:Eight consecutive mechanically ventilated term infants with se...
journal_title:Clinical drug investigation
pub_type: 杂志文章
doi:10.2165/00044011-200626010-00002
更新日期:2006-01-01 00:00:00