Infliximab in extrapulmonary sarcoidosis: tantalising but inconclusive

It is a truth universally acknowledged that a new therapy with exciting prospects must be in want of placebo-controlled evaluation. In this issue of the European Respiratory Journal , Judson et al. 1 report that in a study of patients with sarcoidosis, the combined group with one of two infliximab regimens had a statistically significant reduction in the degree of extrapulmonary organ involvement, compared with the placebo group. Infliximab has been reported to be beneficial in small groups of patients with aggressive sarcoidosis and, therefore, it might be thought that the data of Judson et al. 1 herald a brave new therapeutic future for infliximab in extrapulmonary disease. The reality is otherwise. The data provide limited encouragement for the use of this therapy in extrapulmonary sarcoidosis, but the findings are, simply put, inconclusive. There appears to be an almost equal likelihood of an overstatement and an understatement of a treatment effect, for two different reasons. The bias inherent in placebo-controlled evaluations of novel therapies now requires urgent attention. In brief, if a novel studied treatment is also available for open use, patients and referring physicians may be less likely to accept its enrolment in a placebo-controlled study 2. Trials of therapies that are not routinely available are quite another matter. In the study by Judson et al. 1, the primary purpose was to measure efficacy in pulmonary disease but the post hoc analysis of a systemic therapeutic effect creates its own difficulties. More importantly, it is known that open infliximab therapy was available, to some of these investigators, for patients with more aggressive disease and it can reasonably be argued that the enrolled population was a relatively nonprogressive subgroup with, by definition, less opportunity for a treatment benefit. This concern applies equally to the small, average therapeutic benefit …