FOR BIOLOGIC-NAIVE PATIENTS WITH ANKYLOSING SPONDYLITIS
ASAS40 results in as fast as 16 weeks and maintained through week 521,2,4,5
COAST-V was not designed to test the noninferiority or superiority of Taltz to Humira
*Nominal P value: Taltz P=.003, Humira P=.001 vs placebo. Not controlled for type-I error; therefore, no conclusions can be made between active treatment arms. Results at week 2: Taltz=20%, Humira=21%, Placebo=5%
†P<.0001 vs placebo at week 16.
‡P=.0053 vs placebo at week 16.
Primary endpoint=ASAS40 at week 16.
The extended treatment period of the study (weeks 16-52) has limitations (ie, no placebo comparison, patients remaining in the extension phase may be those more responsive to Taltz treatment).
ASAS scores measure degrees of spinal pain, physical function, patient global assessment, and inflammation.
NRI of intent-to-treat population through weeks 16 and 52.
Among biologic-naive patients, 64% receiving Taltz, 59% receiving Humira, and 40% receiving placebo achieved ASAS20 at week 16. At week 52, 65% of patients receiving Taltz achieved ASAS20.
COAST-V was not designed to test the noninferiority or superiority of Taltz to Humira. Thus, these data should not be used to compare the efficacy between these products.
Additional week 52 results from COAST-W trial, NRI1, 3, 6
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
Serious hypersensitivity reactions, including angioedema and urticaria (each ≤0.1%), occurred in the Taltz group in clinical trials. Anaphylaxis, including cases leading to hospitalization, has been reported in postmarketing use with Taltz. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy.