Addition of fexofenadine to a topical corticosteroid reduces the pruritus associated with atopic dermatitis in a 1-week randomized,multicentre, double-blind,placebo-controlled,parallel-group study

BACKGROUND: Fexofenadine, a nonsedating, H1-receptor selective antihistamine, exhibits consistent efficacy and safety in the treatment of allergic rhinitis and urticaria. The pruritus associated with atopic dermatitis is considered to be induced, in part, by histamine. Therefore, we thought that fexofenadine may be useful in the relief of pruritus associated with atopic dermatitis. OBJECTIVE: To compare the efficacy of twice-daily fexofenadine hydrochloride (HCl) 60 mg vs. placebo in reducing the pruritus associated with atopic dermatitis. METHODS: In this randomized, multicentre, double-blind, placebo-controlled study, patients (aged >or= 16 years) with atopic dermatitis underwent a 1-week placebo lead-in period, followed by randomization to fexofenadine HCl 60 mg twice daily or placebo for 1 week. All patients also received topical treatment with 0.1% hydrocortisone butyrate twice daily throughout the study. The primary efficacy endpoint was mean change in pruritus score from baseline. Patients reflectively recorded pruritus scores twice daily (day and night) using a five-point scale (0 = none; 4 = very severe). RESULTS: Fexofenadine (n = 201) significantly decreased the severity of pruritus compared with placebo (n = 199) (mean change in score -0.75 (unadjusted 95% confidence interval [-0.88, -0.62]) vs. -0.5 [-0.62, -0.38], respectively; P = 0.0005). This improvement was seen after just 1 day of treatment (P = 0.039) and was maintained throughout the treatment period (P = 0.019). Compared with placebo, fexofenadine significantly improved both diurnal (P = 0.0001) and nocturnal pruritus (P = 0.013). In addition, significantly more patients in the fexofenadine group experienced a reduction in the ratio of pruritus area to body surface area compared with those in the placebo group (P = 0.007). The incidence of adverse events was low and similar across all treatment groups. CONCLUSIONS: Fexofenadine HCl 60 mg twice daily demonstrated a rapid, significant improvement in the pruritus associated with atopic dermatitis, with a safety profile equivalent to that of placebo.     

Patient-reported outcomes of psoriasis improvement with etanercept therapy: results of a randomized phase III trial

BACKGROUND: Etanercept, a soluble tumour necrosis factor receptor, lessens the severity of psoriasis as measured by physician-reported clinical outcomes. Equally important is the patient perspective on the effect of etanercept therapy on daily life. OBJECTIVES: To assess patient-reported outcomes (PROs) in patients with psoriasis receiving etanercept therapy. METHODS: In this multinational, randomized, phase III trial, patients with psoriasis received placebo (n = 193), etanercept 50 mg per week (n = 196) or etanercept 50 mg twice weekly (n = 194) during the initial 12-week, double-blind period. Thereafter, all patients received open-label etanercept (50 mg per week). The following PROs were assessed: Dermatology Life Quality Index (DLQI), Short Form-36 Health Survey (SF-36), patient rating of pruritus, and patient global assessment of psoriasis. RESULTS: At week 12, DLQI total score improved by 65-70% in patients receiving etanercept compared with 6% in patients receiving placebo (P < 0.0001), and improvement in DLQI was clinically meaningful (> or = 5-point improvement or 0 score) for 72-77% of patients receiving etanercept therapy. All DLQI and SF-36 subscales and the SF-36 physical and mental component summary scores demonstrated significantly greater improvement with etanercept therapy than with placebo, illustrating that etanercept benefits patients with psoriasis across multiple domains that contribute to health-related quality of life. With etanercept therapy, distributions of patient ratings of pruritus and global assessment of disease shifted from moderate to severe (baseline) to minimal to good (week 12). Etanercept-induced benefits of PROs were maintained for patients who reduced their dose after 12 weeks. CONCLUSIONS: Etanercept therapy improves PROs in patients with psoriasis and makes a meaningful difference to their lives. These results support the efficacy profile of physician-reported clinical measures while providing a more complete understanding of the benefits experienced by patients with psoriasis treated with etanercept.     

Review of fexofenadine in the treatment of chronic idiopathic urticaria

Chronic idiopathic urticaria (CIU), characterized by the appearance of itchy wheals of unknown etiology, can be extremely debilitating and can significantly reduce a patient's quality of life (QOL). Fexofenadine, a non-sedating, H1-receptor selective, long-acting antihistamine, is licensed worldwide for the treatment of CIU. A number of dose-ranging studies have evaluated the efficacy and safety of fexofenadine for the the treatment of CIU. In two similar North American studies, patients received either fexofenadine HCI (20, 60, 120, or 240 mg bid) or placebo. All four doses of fexofendine were statistically superior to placebo at reducing pruritus and reducing the number of wheals (P < or = 0.0238). A dose-finding study undertaken in Japanese patients confirmed that fexofenadine HCI (60 mg and 120 mg bid) is an effective treatment for CIU. A similar dose response was shown in all three studies when the results were compared. Furthermore, health outcome analyses of the North American studies indicated that fexofenadine HCI 60 mg bid significantly improved patient's QOL. In these studies, fexofenadine had a consistently comparable safety profile to placebo, with no dose-related trends in the incidence of adverse events. In conclusion, fexofenadine is an effective and well-tolerated treatment for CIU, with a wide therapeutic window. Importantly, the lack of ethnic differences between the studies from North America and Asia indicate that the efficacy and safety of fexofenadine demonstrated in these studies are cross-culturally applicable.     

Quality of life in adults with chronic idiopathic urticaria receiving desloratadine: a randomized, double-blind, multicentre, placebo-controlled study

Objective To assess the effect of desloratadine on quality of life (QoL) in chronic idiopathic urticaria (CIU). Study population Patients with a history of CIU (pruritus and weals lasting = 6 weeks) were included in this multicentre, randomized, double‐blind placebo‐controlled study that took place in dermatology centres throughout France. During the study, patients were randomized to receive desloratadine 5 mg daily or placebo for 42 days. Main outcome measures Variation of the scores of two QoL dermatology‐specific tools between baseline and day 42, the French translation version of the Dermatology Life Quality Index (DLQI) and the VQ‐Dermato (a French‐language scoring instrument). Results The intent‐to‐treat population comprised 137 patients [desloratadine (n = 65) or placebo (n = 72)]. Desloratadine treatment was associated with significantly greater improvements from baseline to day 42 compared with placebo in DLQI overall score (–6 vs. –2.2 points; P < 0.002) and VQ‐Dermato score (18.5 vs. 29.1 points; P = 0.009). Mean scores for sleep disruption and disruption of daily activities were significantly lower in the desloratadine group than in the placebo group from day 1 to the end of the study. Conclusions Desloratadine 5 mg/day was associated with significant improvements in two separate dermatology‐specific measures of QoL in patients with CIU. QoL proved to be a relevant primary outcome measure for therapeutic trials in CIU.     

Measuring quality of life in patients with psoriasis using the Arabic version for Morocco of the Dermatology Life Quality Index

Background  Psoriasis has been demonstrated to have substantial impacts on dermatology‐related functional limitations and health‐related quality of life (HRQL). This study evaluated the HRQL in Moroccan psoriatics using the Arabic version of the Dermatology Life Quality Index (DLQI) and examined the psychometric properties of the questionnaire. Materials and methods  The Moroccan Arabic version of the DLQI was developed and approved by the author of the questionnaire. The DLQI was administered to inpatient and outpatient adult psoriatics. Some participants completed the DLQI for a second time. Demographic and clinical characteristics were collected. Reliability of the DLQI was tested using Cronbach’s coefficient alpha and intraclass correlation coefficient (ICC). Factor structure was tested by explanatory and confirmatory factor analysis. Construct validity was tested by known‐groups comparison using the generalized linear model to assess factors influencing patients’ HRQL. Results  A total of 176 psoriatics completed the questionnaire. The mean age was 36 ± 14 years. The mean Psoriasis Area and Severity Index (PASI) score was 11.8 ± 7.9. The mean DLQI score was 12.7 ± 5.9 (the higher the score the greater the impairment of HRQL). Cronbach’s alpha coefficient was 0.84. ICC was 0.97. The principal component analysis confirmed the bidimensional structure of the questionnaire. Factors associated with poorer HRQL were higher PASI (P < 0.001), pustular and erythrodermal clinical forms (P < 0.001), and older age (P = 0.001). Conclusions  The Arabic version for Morocco of the DLQI is reliable and valid. Severity of the psoriasis, older age, and severe clinical forms influence the HRQL of patients.     

Levocetirizine is an effective treatment in patients suffering from chronic idiopathic urticaria: a randomized, double-blind, placebo-controlled, parallel, multicenter study

BACKGROUND: Chronic idiopathic urticaria (CIU) is defined by the almost daily presence of urticaria for at least 6 weeks without an identifiable cause. Symptoms include short-lived wheals, itching, and erythema. CIU impedes significantly a patient's quality of life (QoL). Levocetirizine is an antihistamine from the latest generation approved for CIU. AIM: To investigate the efficacy of levocetirizine, 5 mg, and placebo for the symptoms and signs of CIU, as well as for the QoL and productivity. METHODS: The primary criteria of evaluation were the pruritus severity scores over 1 week of treatment and over 4 weeks. The QoL was assessed via the Dermatology Life Quality Index (DLQI). RESULTS: Baseline pruritus severity scores were comparable in the two treatment groups (2.06+/-0.58). After 1 week, levocetirizine was superior to placebo and demonstrated a considerable efficacy (difference=0.78, P<0.001). This efficacy was maintained over the entire study period (4 weeks, P<0.001). The number and size of wheals were considerably reduced compared with placebo over 1 week and over the total treatment period (P 相似文献   

Health‐related quality of life among Darier’s disease patients

Background Darier’s disease (DD) is an autosomal dominant skin disorder characterized by persistent eruption of hyperkeratotic papules. The effect of DD on quality of life (QOL) has been assessed in only one study, which found no correlation between the Dermatology Life Quality Index (DLQI) score and clinical severity of the disease. The correlation between health‐related quality of life (HRQL) and other diseases and patient characteristics has not been studied. Objectives To examine the HRQL of patients with DD and to evaluate the association between HRQL scores and disease and patient characteristics. Methods A total of 74 DD patients completed three QOL questionnaires: DLQI, EQ‐5D, and one specially designed for the study. The data reported in this study were collected as part of a larger study on the clinical characteristics of DD; the socio‐demographic and clinical data were used in the statistical analysis of the current study. Results Mean DLQI was 5.41 ± 5.57 and the mean EQ‐Visual Analogue Scale (VAS), was 70.84 ± 19.25. DLQI and EQ‐VAS were significantly associated with skin area affected, disease severity, age at onset of DD and a seborrhoeic distribution pattern of DD. Stepwise linear regression showed skin area affected to be the most significant variable in the predication of DLQI (beta = 0.183; SE = 0.04; P < 0.001), and disease severity the most significant variable in the predication of EQ‐VAS (beta = ?9.15; SE = 3.21; P < 0.006). Conclusions Darier’s disease has a negative impact on HRQL of patients and the HRQL is associated with various disease characteristics, mainly skin area affected and clinical severity.     

Efficacy and safety of mizolastine 10 mg in a placebo-controlled comparison with loratadine in chronic idiopathic urticaria: results of the MILOR Study.

BACKGROUND: Mizolastine is a novel histamine H1-antagonist registered in Europe for the management of allergic rhinitis and urticaria. OBJECTIVES: To compare the clinical efficacy and safety of mizolastine with loratadine and placebo in patients with chronic idiopathic urticaria (CIU). METHODS: A multicentre, double-blind, parallel group study was designed in which 247 patients with CIU were randomised after a 1-week placebo run-in period to 10 mg daily mizolastine (n = 88), 10 mg daily loratadine (n = 79), or placebo (n = 80) for a 4-week treatment period. RESULTS: Mizolastine and loratadine both relieved symptoms of CIU. After 2 weeks' treatment, the severity of pruritus (visual analogue score (VAS) assessed by patients) decreased significantly in both the mizolastine and loratadine groups compared with placebo (mizolastine: -36.7 mm, P = 0.0001; loratadine: -29.8, P = 0.0071; placebo: -16.3); this improvement with both active treatments was maintained throughout the treatment period, the difference being significant only for the mizolastine group (P = 0.0090). Both active treatments were also associated with reduced weekly episodes of urticaria compared with placebo, which was significant after 2 weeks' treatment (mizolastine: 7.9 episodes, P = 0.0061; loratadine: 8.3, P = 0.0221; placebo: 13.3). Angioedema was improved to a clinically significant extent with mizolastine, and loratadine compared with placebo in those patients who had this symptom before treatment. Overall tolerability of both treatments was similar to placebo, and there were no clinically relevant effects on cardiac repolarisation with either mizolastine or loratadine. CONCLUSION: Mizolastine (10 mg daily) is confirmed as an effective and well tolerated agent, comparable to loratadine and superior to placebo, for the management of CIU. Mizolastine acted as rapidly as loratadine in improving urticarial symptoms from the first day of treatment.     

Effect of vitiligo on self-reported health-related quality of life

BACKGROUND: Vitiligo is a pigmentary disorder affecting at least 1% of the total population. Although the disease does not produce direct physical impairment, it may considerably influence the psychological well-being of the patients. It has been suggested that patients suffer from low self-esteem, poor body image and a poor quality of life. The majority of the studies on the psychosocial impact of vitiligo were conducted in the U.S.A. and England. OBJECTIVES: This study aims to quantify the burden of vitiligo by estimating health-related quality of life in the Dutch-speaking Belgian population (Flanders). This is compared with the level of disability caused by psoriasis in a similarly recruited population. It is also our purpose to detect those at risk of experiencing a poor quality of life and to identify variables that might predict this impairment. PATIENTS AND METHODS: Patients with vitiligo (n = 119) and 162 patients with psoriasis were included in a postal survey. In order to obtain a patient-based measurement of quality of life we used the Dermatology Life Quality Index (DLQI), a widely validated questionnaire that is easy to use and allows comparison between several skin disorders. Other survey questions were related to demographic data and disease-related characteristics. RESULTS: We obtained excellent response rates in both patient groups. The overall mean DLQI score for vitiligo (4.95) was lower than that for psoriasis (6.26) (P = 0.01). Patients with vitiligo experienced significantly less impairment of life quality from the symptoms and treatment of the disease (P < 0.001). The highest individual mean scores in vitiligo were found for Q2 (feelings), Q4 (clothing), Q5 (social and leisure activities) and Q3 (daily routine). The interaction of disease and sex on the DLQI score was highly significant (P = 0.001). While men with vitiligo scored significantly lower than men with psoriasis (P < 0.001), we found a comparable overall DLQI score for women in these disease groups. The number of consultations (P = 0.005) and severity of the disease (P < 0.001) were independently related to the DLQI. CONCLUSIONS: Our study quantifies the burden on the quality of life caused by vitiligo and indicates specific areas of patients' lives which are most affected by the disease. Sex, number of consultations and subjective disease severity independently predict the quality of life. The quality of life impairment in women affected with vitiligo equals the impairment caused by psoriasis in our study population. These results should awake the interest of physicians in this 'cosmetic' disease, since appropriate treatment is likely to improve the quality of life of vitiligo patients.     

盐酸非索非那定片递减疗法治疗慢性自发性荨麻疹的疗效观察

目的：探讨盐酸非索非那定片递减疗法治疗慢性自发性荨麻疹的有效性。方法在临床病史评估和自体血清皮肤试验（ASST）的基础上,将80例慢性自发性荨麻疹患者随机分配到常规剂量组和递减剂量组。常规剂量组给予口服盐酸非索非那定片120 mg/d,连续12周;递减剂量组前4周每日给予口服盐酸非索非那定片120 mg/d,第5周和第9周时尝试逐渐减量至可控制症状的最小服药量。在治疗前（基线）和治疗后第4、8、12周时评价所有患者荨麻疹疾病活动程度（UAS）、皮肤病生活质量指数（DLQI）和抗组胺药物总服用量。结果共76例患者完成12周的治疗,包括常规剂量组37例和递减剂量组39例。治疗4、8、12周后,常规剂量组（UAS 0.64±0.82、0.37±0.68、0.27±0.56;DLQI：3.62±1.82、2.81±1.65、1.37±1.14）和递减剂量组（UAS：0.61±0.87、0.48±0.72、0.28±0.61;DLQI：3.79±2.57、2.74±2.11、1.15±1.47）UAS、DLQI评分均分别显著低于各组治疗前评分（UAS：4.08±0.79、4.07±0.81;DLQI：16.19±3.79、15.92±4.2）,差异有统计学意义（均P<0.001）,但两组在治疗后同一时间UAS和DLQI评分差异均无统计学意义（P>0.05）。递减剂量组在治疗8、12周后分别有71.79%（28/39）和82.05%（32/39）患者在原有剂量基础上减少剂量仍能控制症状,且服药总量显著低于常规剂量组对应时间段的药量（均P<0.001）。结论慢性荨麻疹患者使用盐酸非索非那定治疗4~8周后,逐步减少药物剂量可取得与常规剂量类似的临床疗效。     

Efficacy and Safety of Desloratadine in Adults with Chronic Idiopathic Urticaria

Background and objective: Chronic idiopathic urticaria (CIU), a condition characterized by pruritus and wheals, can cause patients physical and psychological distress. Desloratadine, a second-generation histamine H1 receptor antagonist (antihistamine), is a first-line treatment option for CIU. The objective of this study was to evaluate the efficacy and safety of once-daily desloratadine 5mg versus placebo for the treatment of CIU symptoms and disease severity in adults. Methods: This was a randomized, placebo-controlled, multicenter trial of 137 adult patients with active CIU who received oral once-daily desloratadine 5mg or placebo for 6 weeks. Outcome measures included pruritus severity, number of wheals, and the size of the largest wheal. Patients assessed signs and symptoms on a four-point scale twice daily. The overall therapeutic response at the end of the 6-week treatment period was also rated. Results: Desloratadine treatment was associated with significant improvements compared with placebo in pruritus scores and in the size of the largest wheals as early as day 1. These improvements continued through to the end of the trial. The mean score for the number of wheals was significantly lower in the desloratadine group than in the placebo group on days 14 and 42 (p ≤ 0.016). Overall improvement in CIU (complete, marked, or moderate therapeutic response) was also greater at the end of the study in the desloratadine group compared with placebo (p < 0.001). Adverse events occurred with similar frequency among desloratadine- and placebo-treated patients. Conclusion: Once-daily desloratadine 5mg is well tolerated and superior to placebo in reducing pruritus and wheals associated with CIU. Desloratadine provided rapid and sustained relief of CIU symptoms as early as after the first dose and maintained this effect until the end of the 6-week treatment period.     

Evaluation of the efficacy and safety of fexofenadine in the management of chronic idiopathic urticaria: a prospective study with 512 patients

Five hundred and twelve patients with chronic idiopathic urticaria (CIU) were treated with fexofenadine at a dose on 180 mg/day. Maximum number of patients were between 20 to 40 years of age and female to male ratio was 1.45:1. The severity of itching was calculated on a scale of 0 to 4 and was recorded by the patients. The mean daily total symptom score (TSS) was measured as sum of the patients' pruritus and number of wheal scores (0 to 7). A mean TSS was determined for each week. Baseline TSS came down to '0' by 4 weeks in all groups except those with TSS 4. There was no correlation between the baseline TSS and degree of improvement. Of 512, 14 (2.73%) patients did not complete the study. The commonest adverse effect was headache (9.04%). There was no report of drowsiness or cardiac arrhythmia. In no patient fexofenadine had to be withdrawn because of its adverse effects.     

The effect of L-thyroxine treatment on chronic idiopathic urticaria and autoimmune thyroiditis

Autoimmune thyroiditis (AT) is more prevalent in patients with chronic idiopathic urticaria CIU) than in the general population. Previous small studies without any controlled comparison reported that CIU remits in patients with CIU and AT treated with L-thyroxine. To determine whether l-thyroxine treatment can improve the clinical course of CIU in patients with the co-occurrence of AT and CIU. A total of 749 patients with CIU were retrospectively studied. Clinical and laboratory evaluation and classification of chronic urticaria were performed according to the EAACI/GA(2)LEN/EDF/WAO guidelines. After L-thyroxine treatment for 53 ± 19 days, euthyroidism was restored in all subjects. Urticaria activity score (UAS) was evaluated at baseline and after three and six months. The control group consisted of matched 44 euthyroid subjects with CIU. A total of 44 (5.9%) patients were diagnosed to have hypothyroidism related to AT. Autologous serum skin test (ASST) was found to be positive in 17 (38.6%) of them. There was no statistically significant difference in baseline UAS, between the ASST+ (3.94 ± 1.52) and the ASST- (3.63 ± 1.42; P = 0.27) hypothyroid subjects and the euthyroid CIU controls (3.73 ± 1.74). During the L-thyroxine treatment, a significant reduction of UAS was observed in both hypothyroid ASST+ and ASST- subjects. However, the mean UAS after three and six months of L-thyroxine treatment remained not significantly different from that in control euthyroid subjects with CIU. L-Thyroxine treatment has no effect on the course of CIU in patients with CIU and AT.     

Desloratadine 5 mg once daily improves the quality of life of patients with chronic idiopathic urticaria

BACKGROUND: Chronic urticaria is known to debilitate a person's quality of life via sleep disruption, itching lesions, fatigue, social isolation, energy loss and emotional/sexual difficulties. Once-daily desloratadine significantly improved the signs and symptoms of CIU. OBJECTIVE: Assess the effect of desloratadine 5 mg once daily on the quality of life of patients suffering of chronic idiopathic urticaria (CIU). Study population One-hundred twenty-one consecutive patients with CIU present for at least 6 weeks prior to inclusion and with a current flare of at least 3 weeks, were included in the study in 24 Belgian centres. RESULTS: The mean dermatology life quality index (DLQI) significantly decreased from baseline to day 7 and further to day 42. Sixty per cent and 77% of patients had a clinically significant change (i.e. a decrease of at least 2 points) at day 7 or day 42, respectively, as compared with that of day 0. Change in pruritus and size of the hives significantly correlated with the change in the score of the quality of life. One-third of patients experienced complete relief whereas in 1 of 10 patients no effect was experienced. CONCLUSIONS: Desloratadine significantly improves the quality of life of patients with chronic idiopathic urticaria as reflected by the dermatology life quality index (DLQI).     

Efficacy and safety of methantheline bromide (Vagantin®) in axillary and palmar hyperhidrosis: results from a multicenter,randomized, placebo‐controlled trial

Background Focal hyperhidrosis can severely affect quality of life. So far, knowledge on the effect of systemic therapy of focal hyperhidrosis is limited. Objective To assess the efficacy and safety of methantheline bromide (MB) in the treatment of axillary and palmar‐axillary hyperhidrosis. Methods A multicenter controlled randomized double‐blind clinical trial was conducted in patients with axillary or palmar‐axillary hyperhidrosis defined by a sweat production >50 mg/5 min. Patients received 3 × 50 mg MB daily or placebo over a period of 28 ± 1 days. Main outcome criterion was the reduction of sweat as measured by gravimetry on day 28 ± 1. Quality of life was assessed by Dermatology Life Quality Index (DLQI) and Hyperhidrosis Disease Severity Score (HDSS). Results A total of 339 patients were randomly assigned to receive MB or placebo. On day 28 ± 1, the mean axillary sweat production was 99 mg for MB and 130 mg for placebo compared with 168 mg and 161 mg respectively at baseline (P = 0.004). Patient′s HDSS score decreased in the MB group from 3.2 to 2.4 compared with 3.2 to 2.7 for placebo (P = 0.002). Similar results could be obtained for the DLQI with 9.7 for MB and 12.2 for placebo, which decreased from 16.4 or 17 respectively (P = 0.003). Tolerability was good for both groups. The most frequent adverse event was dry mouth. Conclusion Fifty milligrams methantheline bromide three times a day is an effective and safe treatment of axillary hyperhidrosis.     

The extent and nature of disability in different urticarial conditions

Chronic forms of urticaria are common, often adversely impacting on quality of life. No formal studies have assessed the extent and nature of disability in different types of urticaria. The Dermatology Life Quality Index (DLQI) is a simple and validated 10-item questionnaire designed to measure and compare disability in different skin conditions. In this study, we aimed to assess the disability in different urticarial groups using the DLQI, allowing comparison with previously published DLQI scores in common skin diseases. The DLQI was administered to 170 consecutive patients attending a specialist urticaria clinic over a 4-month period. Consistent with previous studies using the DLQI, mean scores were not influenced by gender or age. Patients with chronic idiopathic urticaria without a concurrent physical urticaria (n = 47) suffered moderate quality of life impairment (mean +/- SD DLQI 25 +/- 24%). In comparison, patients with chronic idiopathic urticaria with concurrent delayed pressure urticaria (DPU) (n = 26) suffered significantly higher quality of life impairment (mean +/- SD DLQI 43 +/- 23%, 95% confidence interval for difference 7-29%). Disability in this group was greatest in the dimensions of work/study, symptoms/feelings and leisure. Subjects with another form of physical urticaria, cholinergic urticaria, also endured high levels of disability (n = 9, mean +/- SD DLQI 50 +/- 34%). From our urticaria study group, we have shown that subjects with DPU and cholinergic urticaria endure the most quality of life impairment. The mean DLQI scores demonstrated in these groups are comparable with those previously seen in severe atopic dermatitis out-patients (60%) and higher than those seen in out-patients with psoriasis (29.7%), acne (24.3%) and vitiligo (16.1%).     

Clinical characteristics of pruritus in chronic idiopathic urticaria

BACKGROUND: Although pruritus is a predominant symptom of chronic idiopathic urticaria (CIU) its clinical characteristics have not been explored. OBJECTIVES: To characterize the clinical pattern and sensory and affective dimensions of the itch experience, utilizing a comprehensive itch questionnaire. METHODS: A structured questionnaire based on the McGill pain questionnaire was used in 100 patients suffering from CIU randomly recruited from a tertiary referral centre. RESULTS: All 100 patients recruited with CIU completed the questionnaire. In 68 patients pruritus appeared on a daily basis. Most patients experienced their pruritus at night and in the evening (n = 83), and 62 reported difficulty in falling asleep. Pruritus involved all body areas, but mostly the arms (n = 86), back (n = 78) and legs (n = 75). Accompanying symptoms were a sensation of heat in 45 patients and sweating in 15. Most patients (n = 98) were prescribed antihistamines (mainly sedating), of whom 34 experienced long-term relief. The sensation of itch was reported to be stinging (n = 27), tickling (n = 25) and burning (n = 23). Seventy-six patients found their pruritus bothersome, 66 annoying and 14 complained of depression. The itch intensity at its peak was more than double that felt after a mosquito bite. The worst itch scores of those who felt depressed were significantly higher than of those who did not (P = 0.018). There was a positive correlation between the sensory and affective scores during worst itch (P < 0.001). CONCLUSIONS: This study describes the itch experienced in CIU, highlighting sensory and affective dimensions. The itch questionnaire was found to be a valuable tool for evaluating pruritus in CIU and its unique features.     

Safety and efficacy of desloratadine in chronic idiopathic urticaria in clinical practice: an observational study of 9246 patients

Background  Post-marketing surveillance studies (PMSS) of medications are often mandated by authorities, provide crucial insights for health services and are useful to define the clinical profiles of therapies. Desloratadine, a non-sedating, second-generation H₁-receptor antagonist, is an effective and well-tolerated treatment for chronic idiopathic urticaria (CIU).
Methods  A PMSS in CIU patients evaluated the tolerability and efficacy of desloratadine in clinical practice. At Visit 1 (baseline), demographic and CIU history were recorded and patients/physicians rated the severity of CIU symptoms, interference with sleep/daily activities and the general state of urticaria. Patients also noted the use and effectiveness of previous antihistamine therapy. At the end of treatment (Visit 2), CIU symptom severity and other disease criteria were re-assessed. Adverse events reported during or ≤ 30 days after treatment were collected.
Results  A total of 9246 patients with CIU participated (63% female). Itching, number of wheals and the size of the largest wheal decreased significantly from baseline with desloratadine therapy ( P <  0.0001). Improvements in CIU-impaired sleep and daily activities were reported by 67% and 71% of patients, respectively ( P <  0.0001). In patients that received previous therapy with cetirizine, loratadine or fexofenadine alone, patients rated the onset of efficacy of desloratadine as faster in 55.5%, 54.7% and 57.6% of cases, respectively. The incidence of adverse events was low (0.5% of patients) and no serious adverse events were reported.
Conclusions  This large PMSS confirms evidence from multiple placebo-controlled trials that desloratadine is effective and well tolerated in the treatment of CIU.

Conflicts of interest

None declared     

Desloratadine for Chronic Idiopathic Urticaria

Chronic idiopathic urticaria (CIU) is a disabling affliction that considerably limits patients' daily activities and interferes with sleep. Clinical studies have shown that histamine H1-receptor antagonists (antihistamines) are highly effective for inhibiting the hives/wheals and pruritus associated with CIU, as well as improving patients' quality of life. Desloratadine is a rapid-acting, once-daily, nonsedating selective H1-receptor antagonist/inverse receptor agonist with proven clinical efficacy in patients with CIU. It has 10-20 times the in vivo H1 receptor-binding affinity of loratadine, its parent compound, and 52-194 times the H1 receptor-binding affinity of cetirizine, ebastine, loratadine, and fexofenadine. Desloratadine displays linear pharmacokinetics after oral administration. Age and sex have no apparent effect on the drug's metabolism and elimination, and food does not affect its bioavailability or absorption. Desloratadine also exerts anti-inflammatory effects via mechanisms that are independent of H1-receptor antagonism. Results from randomized, double-blind, placebo-controlled studies of 6 weeks' duration in adults and adolescents with moderate-to-severe CIU indicate that desloratadine significantly minimizes the severity of pruritus, reduces the number and size of hives, and improves disease-impaired sleep and daily activities. Improvements were noted after a single dose of desloratadine and were maintained over 6 weeks of treatment. Desloratadine was safe and well tolerated in clinical trials of patients with CIU. The adverse effect profile of desloratadine in adults, as well as in children aged from 6 months to 11 years, is comparable to that of placebo. Evaluations of cognitive and psychomotor performance in adults indicate no impairment of function with dosages of desloratadine 5 mg/day. In conclusion, desloratadine is an important therapeutic option for prompt and enduring symptom relief in patients with moderate-to-severe CIU. In addition to efficacy and safety, desloratadine affords a convenient administration regimen, rapid onset of action, and an absence of drug-drug or drug-food interactions. Other important prescribing considerations are that, unlike all first-generation and some second-generation antihistamines, desloratadine is nonsedating at its clinically approved dosage and does not impair psychomotor function.