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Already discontinued for rheumatoid arthritis, the candidate drug tabalumab will no longer be tested for lupus either. Observers are taking a positive view of the situation.
Eli Lilly and Company is discontinuing development of the BAFF inhibitor tabalumab for systemic lupus erythematosus (SLE), due to disappointing efficacy results in Phase 3 of the ILLUMINATE trials. The firm halted testing the drug for rheumatoid arthritis last year.
Safety results were not a concern in the lupus trials.
Tabalumab showed statistically significant improvement for one endpoint in one trial, said Lilly Senior Vice President for Product Development J. Anthony Ware MD. But the drug did not create clinically meaningful improvements.
Ware went on to express the hope that data from these studies will continue to inform lupus research, a sentiment echoed by Richard Furie MD, chief of rheumatology at the North Shore-LIJ Health System.
"Although we don’t like seeing negative results in SLE clinical trials research, failed trials have taught us a lot," Furie said in a statement for the Lupus Research Institute, adding that "the fact that the high dose in one of the two studies was effective supports the BLyS (BAFF) pathway as a relevant pathway in SLE. The information gleaned from these trials will help us advance the field.”
The LRI statement points out that other drugs are still used off-label for lupus despite failing in trials, and said the same situation might "unfold" for this drug. Interestingly, tabalumab showed encouraging results in open-label extension trials for RA, although Lilly had halted testing for that indication.