Psoriatic Arthritis skin data
Treatment with Taltz resulted in an improvement in psoriatic skin lesions1-3,16
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.
SELECT IMPORTANT SAFETY INFORMATION
INFLAMMATORY BOWEL DISEASE
Patients treated with Taltz may be at an increased risk of inflammatory bowel disease. In clinical trials, Crohn’s disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group than the placebo group. During Taltz treatment, monitor patients for onset or exacerbation of inflammatory bowel disease and if IBD occurs, discontinue Taltz and initiate appropriate medical management.
Taltz maintained response in skin clearance through year 31,17
In an mNRI analysis of patients receiving Taltz, PASI 75 results were 80% at week 52, 69% at week 108, and 64% at week 156. PASI 90 results were 67% at week 52, 61% at week 108, and 51% at week 156. PASI 100 results were 56% at week 52, 47% at week 108, and 44% at week 156.
mNRI analysis imputes missing data due to study drug (e.g., inadequate response, adverse event, or lack of efficacy) as nonresponse; whereas missing data due to other reasons (e.g., missed visits, lost to follow-up) is included as a predicted value based on statistical modeling of observed data.
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.
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 (e.g., no placebo comparisons, patients remaining in the study may be those with better results).
BSA=body surface area; mNRI=modified nonresponder imputation; PASI=Psoriasis Area and Severity Index.
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.
SELECT IMPORTANT SAFETY INFORMATION
IMMUNIZATIONS
Prior to initiating Taltz, consider completion of all ageappropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with Taltz.
References: 1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2020. 2. Nash P, Kirkham B, Okada M, et al; on behalf of SPIRIT-P2 Study Group. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial. Lancet. 2017;389:2317-2327. 3. Mease PJ, van der Heijde D, Ritchlin CT, et al; on behalf of SPIRIT-P1 Study Group. Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naive patients with active psoriatic arthritis: results from the 24-week randomised, double-blind, placebo-controlled and active (adalimumab)-controlled period of the phase III trial SPIRIT-P1. Ann Rheum Dis. 2017;76:79-87. 4. Data on file. Lilly USA, LLC. DOF-IX-US-0013. 5. Data on file. Lilly USA, LLC. DOF-IX-US-0015. 6. Genovese MC, Combe B, Kremer J, et al. Safety and efficacy of ixekizumab in patients with PsA and previous inadequate response to TNF inhibitors: week 52 results from SPIRIT-P2. Rheumatology. 2018. doi:10.1093/rheumatology/key182. 7. Data on file. Lilly USA, LLC. TAL20171026B. 8. Data on file. Lilly USA, LLC. DOF-IX-US-0017. 9. van der Heijde D, Gladman DD, Kishimoto M, et al. Efficacy and safety of ixekizumab in patients with active psoriatic arthritis: 52-week results from a phase III study (SPIRIT-P1). J Rheumatol. 2018;45:367-377. 10. Nash P, Kirkham B, Okada M, et al; on behalf of SPIRIT-P2 Study Group. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial. Lancet. 2017;389:2317-2327. Supplementary appendix. 11. Data on file. Lilly USA, LLC. TAL04022018A. 12. Data on file. Lilly USA, LLC. TAL20171002A. 13. Data on file. Lilly USA, LLC. TAL04022018B. 14. Data on file. Lilly USA, LLC. TAL20170919A. 15. Data on file. Lilly USA, LLC. TAL20171026A. 16. Data on file. Lilly USA, LLC. TAL20171127A. 17. Data on file. Lilly USA, LLC. DOF-IX-US-0012.