“…1 The treatment includes biologic and classic systemic agents, and their safety profile is an important consideration; long-term data, in particular, have raised concerns associated with their prolonged use. [2][3][4][5][6][7] In general, the safety data come from randomized controlled trials (RCTs) or their extensions, 8 usually with short follow-up periods, and from the spontaneous reporting of adverse reactions. 9 RCTs are governed by restrictive inclusion and exclusion criteria involving a selected population, which might have a better safety profile than the general population.…”