Treating lupus: from serendipity to sense, the rise of the new biologicals and other emerging therapies

Chapter 12: Lupus nephritis

“…628 This RCT was based on several small, open-label, uncontrolled trials that suggested rituximab may be effective in proliferative LN, either for refractory disease or as initial therapy. 629, 630, 631, 632, 633, 634, 635 At 12 months, however, there were no differences between the rituximab and placebo groups in terms of complete or partial remissions. Thus, rituximab cannot be recommended as adjunctive initial therapy.…”

Emerging small molecule and biological therapeutic approaches for the treatment of autoimmunity

“…However, clinical trials in SLE have been mixed. Despite numerous open-label investigator trials, which have reported promising results under a variety of regimes [53,54], pivotal controlled Phase III trials for non-renal SLE (EXPLORER trial) and lupus nephritis (LUNAR trial) did not achieve their primary end points. The use of BILAG (British Isles Lupus Assessment Score) for the definition of flares as a primary end point, the use of moderate to high doses of steroids and immunosuppressive medications (e.g., azathioprine, MMF, MTX) as background therapy and the relatively short follow-up may all have been critical components that could have contributed to the failure of the EXPLORER trial [55].…”