Psoriatic Arthritis Efficacy
ACR results
Powerful joint symptom results in both biologic-naive and TNFi-experienced patients1-3
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.
Taltz maintained response in joint symptoms through year 34
In a modified nonresponder imputation (mNRI) analysis of patients receiving Taltz, ACR20 results were 76% at week 52, 70% at week 108, and 70% at week 156. ACR50 results were 60% at week 52, 52% at week 108, and 52% 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).
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.
Powerful joint symptom improvement through week 521,2,5,6
Primary endpoint=ACR20 response at week 24.
Inadequate responders (<20% improvement in tender and in swollen joint counts) at week 16 were analyzed as nonresponders after week 16 until the primary endpoint.
Patients and site personnel were blinded to study treatment until all patients completed week 24 or discontinued. The open-label phase of the study has limitations (eg, no placebo comparison, patients remaining in the extension phase may be those with better results).
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.