Taltz is indicated for adults with active ankylosing spondylitis (AS), adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and for adults with active psoriatic arthritis (PsA). Taltz is also indicated for patients aged 6 years or older with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.
Taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.
nr-axSpA Biologic-Naive Results
Unmet Need
In the US, nr-axSpA is underdiagnosed and undertreated2-5
Significant improvement in nr-axSpA symptoms achieved through week 521,6
*P<.01 vs placebo at week 16.
†P=.0045 vs placebo at week 52.
Primary endpoint=ASAS40 at week 52.
Starting at week 16 and up to week 44, changes could be made to non-biologic background therapy and/or patients could be transitioned to open-label Taltz 80 mg Q2W at the investigators' discretion. Patients who either switched to Taltz 80 mg Q2W, were missing week 16 or week 52 data, or discontinued double-blind treatment were considered non-responders. Taltz 80 mg Q2W is not an approved dose for nr-axSpA.
In a post hoc analysis of the patients in the Q4W arm that switched to open-label therapy (n=40), 25% had achieved ASAS40 at the last visit before switching; these patients were counted as non-responders in the primary outcome analysis at week 527.
SELECT IMPORTANT SAFETY INFORMATION
INFECTIONS
Taltz may increase the risk of infection. In clinical trials of adult patients with plaque psoriasis, the Taltz group had a higher rate of infections than the placebo group (27% vs 23%). A similar increase in risk of infection was seen in placebo-controlled trials of adult patients with psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and pediatric patients with plaque psoriasis. Serious infections have occurred. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue Taltz until the infection resolves.
References: 1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2020. 2. Strand V, et al. Prevalence of axial spondyloarthritis in United States rheumatology practices: Assessment of SpondyloArthritis International Society criteria versus rheumatology expert clinical diagnosis. Arth Care Res. 2013;65:1299-1306. 3. U.S. Census Bureau, Population Estimates Program (PEP), Quick Facts. https://www.census.gov/quickfacts/fact/table/US. Accessed April 30, 2020. 4. Robinson PC, et al. Non-Radiographic Axial Spondyloarthritis (nr-axSpA): Advances in Classification, Imaging and Therapy. Rheumatol Ther. 2019;6:165- 177. 5. Rudwaleit M, et al. The early disease stage in axial spondylarthritis: results from the German Spondyloarthritis Inception Cohort. Arthritis Rheum. 2009;60:717-727. 6. Data on file. Lilly USA, LLC. DOF-IX-US-0225. 7. Deodhar A, et al. Ixekizumab for patients with non-radiographic axial spondyloarthritis (COAST-X): a randomised, placebo-controlled trial. Lancet. 2020; 395:53-64.