Summary
This study from France concerned itself with the biologic drug, omalizumab, as treatment for chronic spontaneous urticaria (CSU). CSU causes troublesome, even debilitating, itchy weals like nettle stings (urticaria), together with swelling of deeper tissues (angioedema) that commonly affects the lips, tongue and eyelids. Omalizumab is licensed for severe CSU that does not respond to high‐dose antihistamines. One hundred and thirty‐six patients with CSU were enrolled and 124 completed the study. They were given three standard doses of omalizumab, every four weeks for 12 weeks. Half the patients also took other medication, usually an antihistamine, to treat their CSU. Researchers and participants knew that all participants were getting omalizumab, and there was no placebo group. Two scoring methods used to assess improvement – the established 7‐day urticaria activity score UAS7 and the newer urticaria control test UCT – were found to correlate i.e. their scores were similar. Omalizumab was effective in two‐thirds of patients as measured by the UAS7 score, and in three‐quarters by the UCT score. These results were not influenced by whether the patients had angioedema. Quality of life scores improved markedly. Mean levels of a blood protein called D‐dimer were increased at the beginning of the study and fell with treatment, but there was no correlation with the improvement in UAS7 or UCT scores. Eight of nine patients with very high D‐dimer levels responded to treatment, so measuring D‐dimer might predict response to omalizumab. Apart from this, the main conclusions were that omalizumab works for CSU and has few side‐effects, and that the UCT is reliable.
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