AbbVie says it has positive mid-stage data for Rinvoq in lupus, will move to PhIII

24 Mar 2023
endpts.com
Phase 2Clinical ResultPhase 3Drug Approval
AbbVie is teasing new Phase II data in the most common form of lupus — and the pharma company says it is good enough to move into a pivotal trial. The drug company shared initial results Thursday , saying that its JAK blockbuster Rinvoq met the primary goals of a Phase II trial in systemic lupus erythematosus. The trial looked at whether Rinvoq led to a reduction of at least four points on a scoring system called SLE Disease Activity Index 2000 without the condition worsening overall or the patient developing substantial disease activity in new organs. It also required that patients not need more than a 10 mg daily dose of steroid prednisone or an equivalent. Based on the results, AbbVie said it plans to move the drug into a Phase III test. The press release only said that the primary endpoint was met. It didn’t show the magnitude of the effect or whether the results were statistically significant. The company declined to comment further. Systemic lupus erythematosus, or SLE, is the most common form of lupus, a chronic autoimmune disease where the immune system attacks the body and can cause extensive amounts of inflammation. The Lupus Foundation of America says 1.5 million Americans have some form of the disease, though the organization doesn’t break that down by subtype. Women make up the majority of patients. Lupus is a disease with limited treatment options. For patients with SLE, there are two drugs approved by the FDA: GlaxoSmithKline’s Benlysta, a B-cell activating factor inhibitor, was the first FDA-approved medicine for SLE in 2011. A decade later, AstraZeneca’s antibody Saphnelo was also cleared for use. Patients in the study were given Rinvoq alone or in combination with AbbVie’s experimental BTK inhibitorBTK inhibitor, elsubrutinib. The study, which enrolled 341 people, divided participants into five different treatment groups: Rinvoq with placebo, Rinvoq in two different doses combined with elsubrutinib, elsubrutinib in combination with placebo, and placebo only. And while GSK and AstraZeneca are in the lead, AbbVie will have to catch up to Bristol Myers Squibb, who is also trying to bridge the gap with its TYK2-targeting oral drug Sotyktu. The pharma company put out word last June that it was pushing into Phase III after Sotyktu reached the primary endpoint of SRI-4 in patients enrolled in a 48-week Phase II study. Bristol Myers, in its Phase II PAISLEY study that had enrolled 363 patients, showed that almost 60% of those taking Sotyktu twice a day reached the SRI-4, compared to just over 33% of those in the placebo group.
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