Strong negative influence upon the quality of life in chronic urticaria is well proved. Before the GA(2)LEN Chronic Urticaria Quality of Life Questionnaire (CU-Q(2)oL) was introduced, the quality of ...life in chronic urticaria had been measured with general or dermatology specific questionnaires. CU-Q(2)oL was initially developed in Italy and consisted of 23 items divided into 6 quality of life dimensions.
The aim of our study was to adapt the Polish version of CU-Q(2)oL and to provide initial results from the Polish sample.
To prepare the Polish version forward and back translation was prepared. After cognitive debriefing, we collected a group of 126 chronic urticaria patients who completed Polish CU-Q(2)oL, Dermatology Life Quality Index (DLQI) and Skindex-29 questionnaire. Disease severity was assessed with Urticaria Activity Score (UAS). We performed the factorial analysis to identify CU-Q(2)oL subscales in our study, internal consistency and convergent validity assessment as well as factors driving the results. Moreover, we analysed tool's reproducibility and responsiveness.
The factor analysis resulted in six subscales of Polish CU-Q(2)oL version with satisfying face validity: Itching, Swelling/Mental status, Functioning, Sleep, Eating/Limits, Embarrassment. All subscales presented recommended internal consistency and convergent validity. Disease severity was the only factor predicting results of all the subscales. Polish CU-Q(2)oL version was reproducible and sensitive to change. We noticed the highest quality of life impairment in Itching and Embarrassment subscales whereas Eating/Limits was the least affected.
Our study supports reliability, responsiveness and validity of the Polish version of CU-Q(2)oL - easy in use, non time-consuming instrument to be used in research, clinical management and treatment outcome assessment and is one more step to confirm quality of life impairment in chronic urticaria.
Patients with chronic urticaria (CU) frequently exhibit positive skin test reactions to autologous serum (ASST). Therapies aimed at inducing tolerance to circulating histamine-releasing factors in ...ASST+ CU patients, e.g. by treatment with autologous whole blood (AWB), have not yet been tested.
To test whether ASST+ CU patients can benefit from repeated low-dose intramuscular injections of AWB.
We characterized CU severity and duration, anti-Fc(epsilon)RI and anti-IgE expression, use of antihistamines, and quality of life in 56 CU patients (ASST+: 35, ASST-: 21) and assessed the therapeutic effects of 8 weekly AWB injections in a randomized, placebo-controlled, single-blind, parallel-group trial.
Numbers, size, intensity, and/or duration of CU symptoms, quality of life, as well as expression of anti-Fc(epsilon)RI or anti-IgE were similar in ASST+ and ASST- CU patients. However, CU in ASST+ patients was of longer duration and required markedly more antihistaminic medication. Interestingly, ASST+ patients, but not ASST- patients, showed significantly (1) reduced CU activity, (2) decreased use of antihistamines, and (3) improved quality of life after AWB treatment. Placebo treatment was ineffective in both groups, but differences of AWB and placebo treatment responses did not achieve statistical significance in either group, most likely due to the limited number of patients treated.
Our findings suggest that ASST+ CU is clinically different from other CU subforms and that ASST+ CU patients can benefit from AWB therapy.
Background Chronic spontaneous urticaria (CSU), a mast cell‐driven condition, is debilitating, common, and hard to treat. Miltefosine, a lipid raft modulator, can inhibit mast cell responses in ...vivo.
Objective To study the safety and efficacy of systemic miltefosine treatment in CSU patients resistant to standard‐dosed antihistamines.
Methods In this investigator‐initiated multicentre, randomized, double‐blind, placebo‐controlled study, CSU patients were treated for 4 weeks with daily doses of up to 150‐mg miltefosine (n = 47) or placebo (n = 26). Disease activity was assessed using the urticaria activity score. Safety and tolerability of miltefosine were also assessed.
Results After 4 weeks of treatment, Urticaria Activity Score (UAS7) levels were substantially more reduced in miltefosine‐treated patients (−6.3 vs. −3.5 in placebo‐treated patients; P = 0.05). Also, the number of weals, but not the intensity of pruritus, was significantly reduced in miltefosine‐treated patients vs. placebo‐treated patients (P = 0.02). In general, adverse events were frequent in both groups (miltefosine: 88%, placebo: 65% of patients) but mostly mild to moderate in severity. We did not observe any serious adverse events.
Conclusions The results of this study indicate that miltefosine is an effective and safe treatment option for CSU patients who do not respond to standard‐dosed antihistamines.
Summary
Acquired cold urticaria (ACU) is a frequent subtype of physical urticaria that is caused by the release of proinflammatory mast cell mediators after cold exposure. Although the underlying ...causes of ACU still remain to be clarified in detail, a wide range of diseases has been reported to be associated with ACU. This review gives an overview of the clinical picture, the differential diagnoses, diagnostic tests and the aetiology of ACU, and summarizes current and novel therapeutic options based on the current literature.
Summary
In dermographic urticaria (DU), shearing forces on the skin result in weals and itching. Second‐generation antihistamines are recommended as the first‐line treatment, but to date only a few ...have ever been tested for this condition. The objective of this pilot study was to assess the safety and efficacy of ebastine in preventing symptoms of DU. Seven adult patients with DU participated in a double‐blind cross‐over trial of ebastine 20 mg. Safety was assessed using a sensitive psychometric battery, testing cognitive performance and mood. Efficacy was assessed by rating weals, erythema, pruritus and burning after challenge. Ebastine had no negative effective on cognitive performance or mood. Weals, pruritus and burning were greatly reduced for most subjects. This pilot study suggests that ebastine is safe and effective in preventing the symptoms of DU and should be tested on a larger scale.
Summary Background Cold urticaria is a rare but severe and potentially lethal condition. It is primarily treated symptomatically with H1‐antihistamines. However, patients have a variable response to ...these drugs and, to date, it has not been possible to predict readily the response to therapy of individual patients.
Objectives To assess the severity of the cold urticaria in naive patients and the response to therapy of patients treated with increasing doses of an H1‐antihistamine by measurement of critical temperature thresholds (CTT) for producing weals on the forearm.
Methods This was a two‐centre, hospital‐based, double‐blind, randomized, parallel‐group study of patients with a confirmed diagnosis of cold urticaria of at least 6 months’ duration. Patient groups received either a constant dose of desloratadine 5 mg daily for 6 weeks (n = 13), or escalating doses of desloratadine: 5 mg daily for the first 2 weeks, 10 mg daily for the second 2 weeks and 20 mg daily for the final 2 weeks (n = 15). Only one adverse event that appeared to be drug related was reported: mild fatigue after treatment with desloratadine 10 mg that lasted for about 3 weeks and resolved at the end of the study.
Results The desloratadine 5 mg daily dose produced a submaximal reduction of mean CTT which remained relatively constant over 6 weeks. Dose escalation increased efficacy, the reduction in mean CTT at four‐times the standard daily dose being significantly greater (P = 0·03) than with the standard dose. Individually, no patient became symptom free (CTT < 4 °C) on 5 mg, while two became symptom free on 10 mg and a further three on 20 mg desloratadine daily.
Conclusions Measurement of CTT allows for individualized risk management and therapy in patients with cold urticaria.
Hereditary angioedema is a life-threatening illness caused by mutations in the gene encoding C1 inhibitor (also called C1 esterase inhibitor) that lead to overactivation of the kallikrein-bradykinin ...cascade. BCX7353 is a potent oral small-molecule inhibitor of plasma kallikrein with a pharmacokinetic and pharmacodynamic profile that may help prevent angioedema attacks.
In this international, three-part, dose-ranging, placebo-controlled trial, we evaluated four doses of BCX7353 (62.5 mg, 125 mg, 250 mg, and 350 mg once daily) for the prevention of angioedema attacks over a 28-day period. Patients with type I or II hereditary angioedema with a history of at least two angioedema attacks per month were randomly assigned to BCX7353 or placebo. The primary efficacy end point was the number of confirmed angioedema attacks. Key secondary end points included angioedema attacks according to anatomical location and quality of life.
A total of 77 patients underwent randomization, 75 received BCX7353 or placebo, and 72 completed the trial. The rate of confirmed angioedema attacks was significantly lower among patients who received BCX7353 at daily doses of 125 mg or more than among those who received placebo, with a 73.8% difference at 125 mg (P<0.001). Significant benefits with respect to quality-of-life scores were observed in the 125-mg and 250-mg dose groups (P<0.05). Gastrointestinal adverse events, predominantly of grade 1, were the most commonly reported adverse events, particularly in the two highest BCX7353 dose groups.
Once-daily oral administration of BCX7353 at a dose of 125 mg or more resulted in a significantly lower rate of attacks of hereditary angioedema than placebo. Mild gastrointestinal symptoms were the principal side effect. (Funded by BioCryst Pharmaceuticals; APeX-1 ClinicalTrials.gov number, NCT02870972 .).
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