FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS

Taltz maintained response in joint symptoms through year 3⁴

Double-blind and open-label extension periods, mNRI and observed

In a modified nonresponder imputation (mNRI) analysis of patients receiving Taltz, ACR20 results were 76% at week 52, 70% at week 108, and 69% at week 156. ACR50 results were 60% at week 52, 52% at week 108, and 51% at week 156. ACR70 results were 40% at week 52, 30% at week 108, and 33% at week 156.

mNRI, a preferred method for analyzing long-term efficacy, imputes missing data due to study drug (eg, inadequate response, adverse event, or lack of efficacy) as nonresponse; whereas missing data due to other reasons (eg, missed visits, lost to follow-up) is included as a predicted value based on statistical modeling of observed data.

After week 24, patients knew they were taking active treatment, but remained blind to the dose until the last patient completed week 24. The uncontrolled extension period of the study has limitations (eg, no placebo comparisons, patients remaining in the study may be those with better results).

Trial design

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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 PSORIATIC ARTHRITIS

Taltz helped stop the progression of structural joint damage at week 16 vs placebo^1-3,7

Primary endpoint=ACR20 response at week 24.

Inhibition of progression of structural damage was assessed radiographically and expressed as the mean change in mTSS and its components, the joint space narrowing score and bone erosion score, at week 16 vs baseline. The mTSS score was modified for psoriatic arthritis by addition of hand distal interphalangeal (DIP) joints.

SPIRIT-P2 (TNFi-experienced) did not include an assessment of radiographic progression.

mTSS=modified Total Sharp Score; MMRM=mixed-effect model of repeated measure.

Trial design

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INFLAMMATORY BOWEL DISEASE
During Taltz treatment, monitor patients for onset or exacerbations 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.

FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS

Taltz showed improvement in patients with preexisting dactylitis^2,3,10

In SPIRIT-P2 (TNFi-experienced) (Taltz 80 mg every 4 weeks n=28, mean baseline=31.5; placebo n=14, mean baseline=37.3), 75% of Taltz patients had complete resolution of dactylitis at week 24 vs 21% for placebo.

The data presented were from post hoc analyses and were not type-I error-controlled; therefore, treatment differences between Taltz and placebo cannot be regarded as statistically significant.

Mean baseline LDI-B was 73.0 for Taltz and 62.7 for placebo.

Inadequate responders (<20% in tender and in swollen join counts) at week 16 were analyzed as nonresponders after week 16 until the primary endpoint.

LDI-B=Leads Dactylitis Index-Basic.

Trial design

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ADVERSE REACTIONS
Most common adverse reactions (≥1%) associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections. Overall, the safety profiles observed in patients with psoriatic arthritis and ankylosing spondylitis were consistent with the safety profile in patients with plaque psoriasis, with the exception of influenza and conjunctivitis in psoriatic arthritis.

FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS

Taltz showed improvement in patients with preexisting enthesitis^2,3,10,12

In SPIRIT-P2 (TNFi-experienced) in patients with LEI >0 (Taltz 80 mg every 4 weeks n=68, mean baseline=2.9; placebo n=69, mean baseline=2.9), LEI=0 at week 24, a prespecified, error-controlled endpoint, was not statistically significant vs placebo. At week 24, 35% of Taltz patients had LEI=0 vs 22% for placebo.

The data presented [from SPIRIT-P1] were from post hoc analyses and were not type-I error-controlled; therefore, treatment differences between Taltz and placebo cannot be regarded as statistically significant. In addition, the mean change from baseline in LEI score at week 12 (prespecified endpoint in SPIRIT-P1) was error-controlled, but was not statistically significant compared to placebo.

Mean baseline LEI was 2.8 for Taltz and 2.9 for placebo.

Inadequate responders (<20% in tender and in swollen join counts) at week 16 were analyzed as nonresponders after week 16 until the primary endpoint.

LEI=Leeds Enthesitis Index.

Trial design

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INFECTIONS
Taltz may increase the risk of infection. In clinical trials of 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 patients with psoriatic arthritis and ankylosing spondylitis. 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.

FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS

Treatment with Taltz resulted in an improvement in psoriatic skin lesions^1-3,15

In SPIRIT-P1, among patients with sPGA ≥3 at baseline (Taltz 80 mg every 4 weeks n=52; placebo n=41), 75% of patients taking Taltz achieved sPGA 0,1 at week 12 vs 7% who received placebo. Additionally, 31% of patients receiving Taltz achieved sPGA 0 at week 12 vs 2% for placebo.

ADDITIONAL WEEK 12 RESULTS FROM SPIRIT-P2 TRIAL

In SPIRIT-P2 (TNFi-experienced, ≥3% BSA) (Taltz 80 mg every 4 weeks n=68, placebo n=67), 57% of patients receiving Taltz achieved PASI 75 at week 12 vs 10% for placebo. Additionally, 38% and 19% of patients receiving Taltz achieved PASI 90 and PASI 100, respectively, at week 12 vs 6% and 6% for placebo. Among patients with sPGA ≥3 at baseline (Taltz 80 mg every 4 weeks n=60, placebo n=55), 63% of patients taking Taltz achieved sPGA 0,1 at week 12 vs 4% of patients who received placebo. Additionally, 23% of patients receiving Taltz achieved sPGA 0 vs 2% for placebo.

Trial design

SELECT IMPORTANT SAFETY INFORMATION
INFLAMMATORY BOWEL DISEASE
During Taltz treatment, monitor patients for onset or exacerbations 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.