AS TNFi-Experienced Results
Significantly more TNFi-experienced patients achieved ASAS40 and ASAS20 with Taltz vs placebo1,7
*P<.05 vs placebo.
†P<.01 vs placebo.
Primary endpoint=ASAS40 at week 16.
ASAS improvement criteria assess improvement in signs and symptoms of AS. Criteria include spinal pain, physical function, global assessment, and inflammation.
Patients with missing data were counted as nonresponders.
NRI of intent-to-treat population through week 16.
TNFi=tumor necrosis factor inhibitor.
Additional week 52 results from COAST-W trial, NRI1,7,8
In COAST-W (TNFi-experienced) (Taltz 80 mg every 4 weeks n=114; placebo n=104), 34% of patients receiving Taltz achieved ASAS40 and 53% of patients receiving Taltz achieved ASAS20 at week 52.
SELECT IMPORTANT SAFETY INFORMATION
INFLAMMATORY BOWEL DISEASE
Patients treated with Taltz may be at an increased risk of inflammatory bowel disease. In clinical trials, Crohn’s disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group than the placebo group. During Taltz treatment, monitor patients for onset or exacerbation of inflammatory bowel disease and if IBD occurs, discontinue Taltz and initiate appropriate medical management.
References: 1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2020. 2. van der Heijde D, Cheng-Chung Wei J, Dougados M, et al. Ixekizumab, an interleukin-17A antagonist in the treatment of ankylosing spondylitis or radiographic axia spondyloarthritis in patients previously untreated with biological disease-modifying anti-rheumatic drugs (COAST-V): 16 week results of a phase 3 randomised, double-blind, active-controlled and placebo-controlled trial. Lancet. 2018;392:2441-2451. 3. Data on file. Lilly USA, LLC. DOF-IX-US-0155. 4. Data on file. Lilly USA, LLC. DOF-IX-US-0157. 5. Data on file. Lilly USA, LLC. DOF-IX-US-0158. 6. Data on file. Lilly USA, LLC. DOF-IX-US-0163. 7. Deodhar A, Poddubnyy D, Pacheco-Tena C, et al. Efficacy and safety of ixekizumab in the treatment of radiographic axial spondyloarthritis: sixteen-week results from a phase III randomized, double-blind, placebo-controlled trial in patients with prior inadequate response to or intolerance of tumor necrosis factor inhibitors. Arthritis Rheumatol. 2019;71:599-611. 8. Data on file. Lilly USA, LLC. DOF-IX-US-0162.