Concomitant MTX use
ACR20 response vs placebo with or without concomitant methotrexate1,14-15
ADDITIONAL WEEK 24 RESULTS FROM SPIRIT-P2 TRIAL
In SPIRIT-P2 (TNFi-experienced) (Taltz 80 mg every 4 weeks n=48; placebo n=40), 50% of Taltz patients achieved ACR20 with concomitant MTX at week 24 vs 18% for placebo. Additionally (Taltz n=74; placebo n=78), 55% of Taltz patients achieved ACR20 without MTX use at week 24 vs 21% for placebo. All patients in SPIRIT-P2 were previously treated with at least 1 cDMARD (methotrexate, sulfasalazine, leflunomide, or hydroxychloroquine)
All patients were allowed to remain on stable background therapy.
Nonresponder imputation (NRI) of intent-to-treat population through 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.
No lab monitoring (including liver function tests) is required for treatment with Taltz as monotherapy.
During Taltz treatment, monitor patients for signs and symptoms of infection and for onset or exacerbation of inflammatory bowel disease. During and after treatment with Taltz, monitor patients for active tuberculosis (TB) infection.
The data presented were from post hoc analyses and were not type-1 error-controlled; therefore, treatment differences between Taltz and placebo cannot be regarded as statistically significant.
MTX=methotrexate.
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.