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Background: Chronic spontaneous urticaria (CSU) is an inflammatory skin disease with a complex physiopathology. Serum amyloid A (SAA), an acute-phase reactant, has been proposed as a potential biomarker in urticaria but has yet to be studied in a population with CSU or correlated with disease activity as indicated by the Urticaria Activity Score summed over 7 days (UAS7). Objective: We sought to determine SAA-1 levels in patients with CSU and correlate them with its activity and control, as well as with clinical features of CSU and other potential blood biomarkers. Methods: We conducted a retrospective multicenter study of 67 patients with CSU, from whom we obtained demographic and clinical data, UAS7 as an indicator of CSU activity, and blood and serum markers. Results: SAA-1 levels positively correlated with UAS7 (rs = 0.47, P < .001). SAA-1 levels were higher in patients with noncontrolled (UAS7 > 6) CSU than in those with controlled (UAS ≤ 6) CSU (P < .001) and were also higher in patients with concomitant angioedema (P = .003) or delayed pressure urticaria (P = .003). Conclusion: We propose SAA-1 as a potential biomarker for activity in CSU. Further studies are required to evaluate its potential role as a biomarker for other CSU outcomes, such as response to treatment.

Background Recurrent idiopathic histaminergic angioedema is currently classified as a subtype of angioedema, as well as a subtype of chronic spontaneous urticaria (CSU), based on the fact that both are mast cell-mediated and respond to the same treatments. Objective In the present work, we sought to verify whether chronic histaminergic angioedema (CHA) is an entity distinct from CSU or represents a CSU subtype that lacks hives. Methods We performed a prospective study comparing 68 CHA patients, angioedema without hives, with 63 CSU patients, with hives and angioedema, from whom we collected demographic and clinical data, as well as blood and serum markers. Results We found key pathogenic features that differentiate CHA from CSU: gender distribution, basophil number, and antibodies against the IgE receptor. The male/female ratio in CHA was 0.78, whereas in CSU it was 0.36 (P = .0466). Basopenia was more often seen in CSU (n = 13 [20%]) than in CHA (n = 5 [7%]). Finally, 31.15% of CSU sera induced basophil activation, whereas no CHA sera were able to activate normal basophils. By contrast, nonspecific inflammation or immune markers, for example, erythrocyte sedimentation rate, C-reactive protein, or IgG antithyroid antibodies, were very similar between both groups. IgE anti–IL-24 could not be assessed because a control population did not differ from CSU. Conclusions Inclusion of CHA as part of the spectrum of CSU is an assumption not evidence-based, and when studied separately, important differences were observed. Until there is further evidence, CHA and CSU should not necessarily be considered the same disorder, and it is our opinion that review articles and guidelines should reflect that possibility.

Background: The daily diary Urticaria Activity Score (UAS) and its weekly score (UAS7) are widely used to assess signs and symptoms in patients with chronic spontaneous urticaria (CSU). The objective of this study was to assess the psychometric properties of a Spanish version of the once-daily UAS. Methods: Observational study in patients ≥18 years old receiving usual care for CSU (daily or almost daily occurrence of generalized hives or angioedema for ≥6 weeks). Patients were included consecutively and completed the UAS, EQ5D, and the Chronic Urticaria Quality of Life scale (CU-Q2oL) at two study visits 6 weeks apart. On each occasion, the UAS was completed once-daily for 7 consecutive days to be able to calculate the UAS7 score. Psychometric properties of reliability, construct validity, and responsiveness were assessed. The Minimal Important Difference (MID) was estimated for the UAS7 using anchor- and distribution-based approaches. Results: Data from 166 patients was available for analysis (mean age 49 years, 65.7% female). Floor (5.4% of patients with the lowest possible score) and ceiling (1.2%) effects were low; 15% of patients had missing values. Internal consistency and test-retest reliability were good (Cronbach’s alpha of 0.83 and an ICC of 0.84, respectively). Convergent validity was demonstrated through the pattern of correlations with the EQ-5D and CU-Q2oL and known groups’ validity was demonstrated by the instrument’s ability to discriminate between patients with different overall levels of urticaria severity, with between-group effect-sizes (ES) ranging from 0.36 to 1.19. The UAS7 proved responsive to change with effect sizes ranging from 0.3 to 1.52 in patients reporting improvement or deterioration in overall urticaria status. The MID for the UAS7 score was estimated at 7–8 points, on a scale of 0–42. Conclusions: The Spanish version of the UAS score has demonstrated a robust psychometric performance in patients with CSU managed in conditions of usual care. It can therefore be considered a suitable instrument to assess disease activity in clinical practice in Spanish-speaking patients. The Spanish version’s reliability and validity are similar to those reported for other language versions of the once- and twice-daily variants of the UAS.

BACKGROUND: Omalizumab is highly effective in controlling chronic spontaneous urticaria (CSU) symptoms; however, patients can experience symptom return on treatment discontinuation. Pivotal clinical trials have identified 2 categories of patients who experience symptom return: rapid and slow. OBJECTIVE: The objective of this study was to identify potential predictors of the speed of symptom return after stopping omalizumab treatment. METHODS: Phase III randomized controlled trial (RCT) data from ASTERIA I (n [ 319; 6 3 4 weekly injections of omalizumab 75, 150, 300 mg or placebo; NCT01287117) and ASTERIA II (n [ 323; 3 3 4 weekly injections of omalizumab 75, 150, 300 mg, or placebo; NCT01292473) were pooled to identify predictors of symptom return after stopping omalizumab treatment (16-week follow-up). The least absolute shrinkage and selection operator regularization regression model was used to select predictive variables, and relapse probability was represented using heatmap visualizations. Model accuracy was tested using data from the GLACIAL phase III RCT (n [ 336; 6 3 4 weekly injections of omalizumab 300 mg or placebo; NCT0126493). RESULTS: Of 746 variables assessed, 2 were selected by the model as predictors of symptom return: baseline urticaria activity score over 7 days (UAS7) and early area above the curve (AAC; determined by plotting the UAS7 scores across time points). Results suggest that high baseline UAS7 and low UAS7 AAC (slow decrease of symptoms) indicate a higher probability of rapid symptom return than low baseline UAS7 and high UAS7 AAC. CONCLUSIONS: These results suggest that the probability of rapid symptom return in patients with CSU who discontinue treatment with omalizumab can be estimated based on baseline UAS7 and early treatment response.

Background: The Long Form and Short Form of the German (original) version of the Urticaria Control Test (UCT) have shown to be valid and reliable instruments for assessing patients with all types of chronic urticaria (CU). The cutoff scores for identifying patients with well-controlled disease were ≥ 24 and ≥ 12 for Long and Short Forms, respectively. However, the sensitivity to change and minimal clinically important difference (MCID) of the UCT have never been systematically evaluated. This study aimed to investigate the validity, reliability, screening accuracy, sensitivity to change and MCID of the linguistically validated translation of the UCT into the Thai language for assessing CU in the Thai population. Methods: A structured translation and pre-testing were done to cross-culturally adapt the UCT for the Thai language. All measurement properties of both forms of the Thai UCT were validated in 169 patients with CU. Results: There were strong correlations between the Thai UCT score and disease activity, health-related quality of life impairment, and disease control (all correlations ≥ 0.7). Good internal consistency and excellent intra-rater reliability were demonstrated. The same cutoff scores to define patients with well-controlled disease should be used as those recommended for the original UCT version. MCIDs equated to increase in scores of 6 and 3 for the Long and Short Forms, respectively, of the Thai UCT should be used to identify patients who had minimal responses. Score increments of ≥10 and ≥ 6 for Long and Short Forms, respectively, should be used to define patients who had marked responses. Conclusions: This study confirmed the applicability of the UCT for use in Thailand, a country that has a very different language and cultural setting than that of Germany and the United States. Further studies are required to examine the suitability of the UCT for use in the pediatric population.

Bilastine is a second generation antihistamine indicated for the treatment of seasonal or perennial allergic rhinoconjunctivitis and chronic urticaria with a daily dose of 20 mg, in adults and children over 12 years of age. The efficacy of bilastine has been shown to be similar to that of the comparator drugs for the control of the nasal and nonnasal symptoms of allergic rhinoconjunctivitis, while also showing a subjective improvement in the quality of life and in overall clinical impression. For chronic urticaria the symptoms (itching and the development of papules) lessens from the second day of treatment onwards, in a similar way to other antihistamines used as comparators. Bilastine should not be administered at meal times to avoid interference with the absorption process. It is not distributed to the central nervous system, is scarcely metabolized, and elimination is through the kidneys and feces, with a 14-hour elimination half-life. It has no effect on cytochrome P450. During clinical development, bilastine was shown to be a drug that is adequately tolerated, with a similar effect to placebo with regard to drowsiness and changes in heart rate. In relation to its use, headaches were the most frequent adverse effect to be reported. No cardiotoxic effects have been observed, and the therapeutic dose does not alter the state of alertness.

Chronic urticaria is a skin disorder characterized by transient pruritic weals that recur from day to day for 6 weeks or more. It has a great impact on patients' quality of life. In spite of this prevalence and morbidity, we are only beginning to understand its physiopathology and we do not have a curative treatment. Moreover, a patient with chronic urticaria may undergo extensive laboratory evaluations seeking a cause only to be frustrated when none is found. In recent years there have been significant advances in our understanding of some of the molecular mechanisms responsible for hive formation. The presence and probable role of IgG autoantibodies directed against epitopes expressed on the alpha-chain of the IgE receptor and to lesser extent, to IgE in a subset of patients is generally acknowledged. These autoantibodies activate complement to release C5a, which augments histamine release, and IL4 and leukotriene C4 are released as well. A perivascular cellular infiltrate results without predominance of either Th1 or Th2 lymphocyte subpopulations. Basophils of all chronic urticaria patients (autoimmune or idiopathic) are hyperresponsive to serum, regardless of source, but poorly responsive to anti IgE. In this review we will summarize the recent contributions to this field and try to provide insights to possible future directions for research on this disease.

Chronic urticaria is a skin disorder characterized by transient pruritic weals that recur from day to day for 6 weeks or more. It has a great impact on patients’ quality of life. In spite of this prevalence and morbidity, we are only beginning to understand its physiopathology and we do not have a curative treatment. Moreover, a patient with chronic urticaria may undergo extensive laboratory evaluations seeking a cause only to be frustrated when none is found. In recent years there have been significant advances in our understanding of some of the molecular mechanisms responsible for hive formation. The presence and probable role of IgG autoantibodies directed against epitopes expressed on the alpha-chain of the IgE receptor and to lesser extent, to IgE in a subset of patients is generally acknowledged. These autoantibodies activate complement to release C5a, which augments histamine release, and IL4 and leukotriene C4 are released as well. A perivascular cellular infiltrate results without predominance of either Th1 or Th2 lymphocyte subpopulations. Basophils of all chronic urticaria patients (autoimmune or idiopathic) are hyperresponsive to serum, regardless of source, but poorly responsive to anti IgE. In this review we will summarize the recent contributions to this field and try to provide insights to possible future directions for research on this disease.