Positive results for Eli Lilly’s Taltz in late stage non-radiographic axial spondyloarthritis trial

The treatment met the primary and all major secondary endpoints in COAST-X, a Phase III study evaluating the safety and efficacy in patients who have non-radiographic axial spondyloarthritis (nr-AxSpA) and are biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve. These results provide clinical evidence to support a potential role for Taltz in the treatment of nr-axSpA patients.

Taltz met the primary endpoint at both week 16 and week 52, demonstrating a statistically significant improvement in the signs and symptoms of nr-axSpA, as measured by the proportion of patients who achieved Assessment of Spondyloarthritis International Society40 (ASAS40) response compared to placebo. The major secondary endpoints were also met at week 16 and week 52.

"Non-radiographic axSpA is a challenging diagnosis that is not only missed in clinics, but also has limited treatment options for physicians to offer patients," said Atul Deodhar, M.D., professor of medicine, Oregon Health & Science University and clinical investigator for the COAST program. "The COAST-X results offer compelling evidence that Taltz could provide a much-needed new alternative if approved for this patient population."

The American drug-maker announced the findings, making way for a regulatory submission later this year.

Axial spondyloarthritis (axSpA) is a chronic inflammatory disease affecting predominantly the sacroiliac joints and the axial skeleton and is estimated to affect 4.5 million adults worldwide.

Taltz is also approved to treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

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