In 154 patients the severity of symptoms was recorded by using the weekly urticaria activity score (UAS 7), and impairment in quality of life was assessed in 156 patients by using the Dermatology ...Life Quality Index (DLQI), as described previously.6 In confirmation of previously published findings, skin reactivity to autologous serum (positive ASST result) was found in 37.5% of all 200 patients with CU tested (Fig 1), and only slightly higher numbers of patients exhibited skin reactivity to autologous plasma (positive APST result, 43.0%), which is in contrast to a previous report in which up to 86% of patients with CU were found to have positive APST results.4 The results for skin autoreactivity were found to be comparable in all 3 study centers and ranged from 42.9% to 43.8% (positive APST result) and 32% to 50% (positive ASST result).
Data from the 3 omalizumab pivotal trials in patients with chronic idiopathic urticaria/chronic spontaneous urticaria (CIU/CSU) represent the largest database of patients reported to date with ...refractory disease (omalizumab, n = 733; placebo, n = 242).
The objective of this study was to compare results from ASTERIA I and II, which included only approved doses of H1-antihistamine as background therapy based on regulatory authority requirements, to those from GLACIAL, which permitted higher doses of H1-antihistamines as well as other types of background therapy, in a post hoc analysis.
Efficacy data from the placebo, omalizumab 150-mg, and omalizumab 300-mg treatment arms of ASTERIA I and II were pooled and analyzed (n = 162 and n = 160, respectively). The 300-mg treatment arm analyses were compared with the analysis of data from GLACIAL (n = 252) using analysis of covariance models. The key efficacy endpoint was change from baseline to week 12 in mean weekly itch severity score (ISS); other endpoints were also evaluated. Safety data were pooled from all 3 studies.
Mean ISS was significantly reduced from baseline at week 12 in the pooled ASTERIA I and II omalizumab 150- and 300-mg treatment arms and in the GLACIAL omalizumab 300-mg arm. The weekly ISS reduction magnitude at week 12 was similar between the omalizumab 300-mg groups in the ASTERIA I and II pooled and GLACIAL studies. Similar treatment effect sizes were observed across multiple endpoints. Omalizumab was well tolerated and the adverse-event profile was similar regardless of background therapy for CIU/CSU. The overall safety profile was generally consistent with omalizumab therapy in allergic asthma.
Omalizumab 300 mg was safe and effective in reducing CIU/CSU symptoms regardless of background therapy.
Background Symptomatic dermographism is the most common type of physical urticaria. It can be severe and poorly controlled with H1 antihistamines in some patients. Photochemotherapy (psoralen plus ...ultraviolet UV A) may help the itch of dermographism but the effect of narrowband (NB) UVB therapy has not been previously studied. Objectives We sought to examine the clinical efficacy of NB UVB therapy for itch and whealing in symptomatic dermographism and to assess the duration of the effect during 3 months of follow-up. Methods Eight patients (6 female) were enrolled into an open uncontrolled prospective study. Intensity of itching and whealing was assessed with visual analog scales and the whealing response was evaluated by testing with a dermographometer at pressures of 20, 36, and 60 g/mm2 on the upper aspect of the back. NB UVB phototherapy was given for 6 weeks 3 times weekly starting at 50% of minimal erythema dose with 20% to 0% increments as tolerated. Fexofenadine (180 mg/d) was taken during the run-in period and subsequently throughout the study and follow-up as required. Patients were followed for 3 months with regular assessments every 6 weeks after completion of phototherapy. Results All patients showed an improvement in itching at the end of NB UVB treatment (mean SD reduction 52.3% 31.6%). Subjective assessment of whealing revealed a significant improvement in all but two patients (mean SD reduction 71% 54%). There was a small and statistically significant improvement in cumulative dermographometer-induced wheal widths at the end of phototherapy ( P = .038). A time trend for the relapse of symptoms within 12 and 18 weeks after completing phototherapy was significant for both visual analog scale scores but not for dermographometer-induced whealing. Limitations The apparent rarity of antihistamine-resistant symptomatic dermographism limited the study to a small number of participants. The severity of the condition did not permit a controlled and blinded study design. Conclusions NB UVB phototherapy is an effective second-line treatment for patients with severe symptomatic dermographism responding poorly to fexofenadine. This therapy can lead to subjective relief of pruritus and whealing and objective reduction of whealing. NB UVB phototherapy may restore symptom control with antihistamines in some patients.
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