FOR TNFi-EXPERIENCED PATIENTS WITH ANKYLOSING SPONDYLITIS

Significantly more TNFi-experienced patients achieved ASAS40 and ASAS20 with Taltz vs placebo³

^*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.

Trial Design

SELECT IMPORTANT SAFETY INFORMATION
PRE-TREATMENT EVALUATION FOR TUBERCULOSIS
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Taltz. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering Taltz. Closely monitor patients receiving Taltz for signs and symptoms of active TB during and after treatment.

FOR BIOLOGIC-NAIVE PATIENTS WITH ANKYLOSING SPONDYLITIS

ASAS40 results in as fast as 16 weeks and maintained through week 52^1,2,4,5

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, NRI^{1, 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.

Trial Design

SELECT IMPORTANT SAFETY INFORMATION
HYPERSENSITIVITY
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 post-marketing use with Taltz. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy.

FOR BIOLOGIC-NAIVE PATIENTS WITH ANKYLOSING SPONDYLITIS

Taltz showed improvement in ASAS components vs placebo^1,7

COAST-V was not designed to test the noninferiority or superiority of Taltz to Humira

^*Mean of BASDAI questions 5 and 6 (morning stiffness duration and morning stiffness severity).

Nominal P value: Individual component scores were not controlled for type-I error; therefore, no statistical comparisons can be made for either treatment arm.

^†P<.001 vs placebo.
^‡P=.008 vs placebo.
^§P=.009 vs placebo.
^‖P=.001 vs placebo.

Primary endpoint=ASAS40 at week 16.

BASDAI scores measure 5 clinical domains through a patient questionnaire.

BASFI is measured using a visual analog scale questionnaire focused on the patient's ability to perform specific functional tasks.

BASDAI range 0-10; spinal pain range 0-10; Patient's Global Assessment score range 0-10; BASFI range 0-10.

BASDAI=Bath Ankylosing Spondylitis Disease Activity Index; BASFI=Bath Ankylosing Spondylitis Functional Index; LSM=least-squares mean.

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 16 RESULTS FROM COAST-W TRIAL, MMRM^1,8

In COAST-W, mean percentage change from baseline in morning stiffness at week 16 was 32% for patients receiving Taltz and 5% for placebo, and mean percentage change from baseline in BASFI was 18% for patients receiving Taltz and 7% for placebo. Mean percentage change from baseline in spinal pain at week 16 was 30% for patients receiving Taltz and 11% for placebo and mean percentage change from baseline in Patient’s Global Assessment score at week 16 was 31% for patients receiving Taltz and 6% for placebo.

Among TNFi-experienced patients, change from baseline in inflammation at week 16 was -2.42 (baseline 7.21) for patients receiving Taltz and -0.70 (baseline 7.20) for placebo, and change from baseline in BASFI at week 16 was -1.69 (baseline 7.35) for patients receiving Taltz and -0.64 (baseline 7.01) for placebo, and change from baseline in spinal pain was -2.4 (baseline 7.9) for patients receiving Taltz and -1.0 (baseline 7.8) for placebo, and change from baseline in Patient’s Global Assessment score at week 16 was -2.4 (baseline 8.0) for patients receiving Taltz and -0.7 (baseline 7.8) for placebo.

Trial Design

SELECT IMPORTANT SAFETY INFORMATION
INFLAMMATORY BOWEL DISEASE
During Taltz treatment, monitor patients for onset or exacerbation of inflammatory bowel disease. Crohn’s disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz 80 mg Q2W group (Crohn’s disease 0.1%, ulcerative colitis 0.2%) than in the placebo group (0%) during clinical trials in patients with plaque psoriasis and in the Taltz Q4W group in ankylosing spondylitis trials (Crohn’s disease 1.0% [2 patients], ulcerative colitis 0.5% [1 patient]) than in the placebo group (Crohn’s disease 0.5% [1 patient], ulcerative colitis 0%). In the ankylosing spondylitis trials, serious events occurred in 1 patient in the Taltz group and 1 patient in the placebo group.