We found that the main cause of the high rate of non-compliance with the package leaflet is patient lack of response to standard treatments, together with clinical practice guides that support the use of rituximab for conditions other than those for which it is indicated. Nevertheless, most of the clinical trials evaluating the efficacy of rituximab for these unauthorized diagnostic profiles have poor methodology, are in phase II, are open studies, have low patient numbers, or in some cases, are not comparative.
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