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As the year 2019 draws to a close, I am reminded how 30 years ago, almost without a warning, the communist dictatorships in Eastern Europe started falling, one after the other. This fall, we are seeing another unlikely and largely unexpected but hoped for grouping of events: a series of successful phase III trials in SLE. These successes follow on a longer period during which successes in smaller, phase II trials were emerging with a range of drugs, including ustekinumab,1 baricitinib,2 cenerimod3 and others. But now, in short succession, three large phase III trials meeting their primary outcome of efficacy were published or announced (table 1).
First, a successful clinical trial in general SLE was published with anifrolumab, a monoclonal antibody directed at the interferon type 1 receptor.4 5 Following a successful phase II trial, an earlier phase III trial of this drug (TULIP 1) had failed as it did not achieve its predefined primary endpoint, the SLE Response Index based on four points (SRI-4).6 However, some secondary outcomes in that trial did achieve statistical significance and suggested meaningful improvements with the drug versus placebo. One of these secondary endpoints was the British Isles Combined Lupus Assessment (BICLA). It was then decided to employ this outcome for the TULIP 2 trial and that trial subsequently confirmed efficacy using the BICLA as the primary outcome (in an ironic twist, the TULIP 2 trial also achieved the SRI-4 outcome, so the change in primary outcome, while …
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