Safety
Physicians and their patients have relied on Taltz since its approval in 20161,2
SPIRIT-P1 and -P2 safety at weeks 24 and 52
IN PsA TRIALS
Common adverse events in pooled SPIRIT-P1 and -P2 trials that occurred through week 521,3
Pooled safety data from SPIRIT-P1 and SPIRIT-P2 clinical trials.
Overall, the safety profile in patients with PsA treated with Taltz is consistent with the safety profile in patients with PsO. The exception is the higher frequency of influenza (Taltz=1.3%, placebo=0.4%) and conjunctivitis (Taltz=1.3%, placebo=0%) in the PsA safety population vs the PsO safety population.1
*The most frequent injection site reactions were erythema and pain. Most injection site reactions were mild to moderate in severity. Discontinuation due to injection site reactions at 24 weeks in the Taltz Q4W arm were 0.4% and 0.4% for placebo.3
†Upper respiratory tract infections cluster includes nasopharyngitis and rhinovirus infection.3
PsA=psoriatic arthritis; PsO=psoriasis; Q4W=every 4 weeks.
SPIRIT-P1 and -P2 adverse events of special interest at weeks 24 and 52
IN PsA TRIALS
Adverse events of special interest from pooled SPIRIT-P1 and -P2 trials through week 521,4,5
Certain adverse effects, such as MACE and malignancy, require longer observation periods and larger patient exposure to ascertain risk. Lilly is conducting continued long-term safety studies, including post-marketing studies, to continue to evaluate the safety of Taltz.
Patients with uncontrolled UC or CD were excluded from the studies; however, patients with a personal or family history of UC/CD were allowed in the study.5
Pooled safety data from SPIRIT-P1 and SPIRIT-P2 clinical trials.
*No confirmed cases of anaphylaxis in clinical trials. All incidents of allergic reactions/hypersensitivity were non-anaphylactic.
†Includes all patients with ≥1 TEAE, including NMSC and prostate cancer.
‡Incidents of inflammatory bowel disease events were reported in the plaque psoriasis trial safety population with Taltz. Before starting a patient, review the Warning and Precaution regarding “Inflammatory Bowel Disease” in the Important Safety Information.1
PsA=psoriatic arthritis; MACE=major adverse cardiovascular event; CD=Crohn’s disease; UC=ulcerative colitis; TEAE=treatment-emergent adverse event; NMSC=nonmelanoma skin cancer.
SPIRIT-H2H safety at weeks 24 and 52
IN A PsA TRIAL
Safety profile of Taltz in SPIRIT-H2H is consistent with registration trials1,6-8
No new safety signals were observed
*Safety data shows all results available at the time of the last patient reaching week 24, including results to week 52.
†Adjudicated: Confirmed IBD event.
‡Patients with uncontrolled UC or CD were excluded from the studies; however, patients with a personal or family history of UC/CD were allowed in the study.
§Adjudicated: Not IBD event.
Certain AEs, such as MACE, malignancy, and cerebrocardiovascular events, require longer observation periods and larger patient exposure to ascertain risk. Lilly is conducting continued long-term safety studies, including post-marketing studies, to continue to evaluate the safety of Taltz.
The most frequent injection site reactions were erythema and pain. Most injection site reactions were mild to moderate in severity.
Patients with multiple occurrences in a single category are counted once for each category; patients may be counted in more than 1 category.
Humira® is a registered trademark of AbbVie Biotechnology Ltd.
PsA=psoriatic arthritis; MACE=major adverse cardiovascular event; CD=Crohn’s disease; UC=ulcerative colitis; IBD=inflammatory bowel disease.
COAST-V and -W safety through week 16 and week 52
IN AS TRIALS
Common adverse events in pooled COAST-V and COAST-W AS trials that occurred through week 16 and week 521,9,10
Through week 16*
Overall, the safety profile observed in patients with AS treated with Taltz Q4W was consistent with the safety profile in patients with plaque PsO.
*Adverse reactions that occurred in ≥2% of Taltz patients.
†Upper respiratory tract infections cluster includes nasopharyngitis.
From week 16 through week 52‡
Pooled safety data from COAST-V and COAST-W clinical trials.
Week 16 to 52 data include patients who were in placebo or adalimumab arm prior to week 16 and were re-randomized to the Q4W extended treatment period.
‡Adverse events that occurred in ≥2% of Taltz patients.
AS=ankylosing spondylitis; Q4W=every 4 weeks; PsO=psoriasis.
COAST-X safety through week 52
IN AN nr-axSpA TRIAL
Common adverse events in the COAST-X trial that occurred through week 16 and week 521,11
Through week 16
Through week 52
Common adverse events defined as ≥2% through week 16 and ≥5% through week 52 and greater than placebo.
Overall, the safety profile observed in patients with nr-axSpA treated with Taltz 80 mg Q4W up to week 16 is consistent with the previous experience of Taltz in other indications.
Starting at week 16 and up to week 44, changes could be made to non-biologic background therapy and/or patients could be transitioned to open-label Taltz 80 mg Q2W at the investigators’ discretion. Patients who initiated open-label Taltz 80 mg Q2W, discontinued initially randomized treatment and remained in the study, or were missing week 16 or week 52 data were considered as nonresponders.
*Upper respiratory tract infections cluster includes nasopharyngitis.
nr-axSpA=non-radiographic axial spondyloarthritis; Q4W=every 4 weeks; Q2W=every 2 weeks.
References: 1. Taltz [package insert]. Indianapolis, IN: Lilly USA, LLC. 2. Data on file. Lilly USA, LLC. DOF-IX-US-0281. 3. Data on file. Lilly USA, LLC. TAL20171016A. 4. Data on file. Lilly USA, LLC. TAL20171026D. 5. Nash P, Kirkham B, Okada M, et al; 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. Supplementary material. Lancet. 2017;389:2317-2327. 6. Mease PJ, Smolen JS, Behrens F, et al; SPIRIT H2H Study Group. A head-to-head comparison of the efficacy and safety of ixekizumab and adalimumab in biological-naïve patients with active psoriatic arthritis: 24-week results of a randomised, open-label, blinded-assessor trial. Ann Rheum Dis. 2020;79:123-131. 7. Data on file. Lilly USA, LLC. DOF-IX-US-0188. 8. Smolen J, Nash P, Tahir H, et al. A head-to-head comparison of ixekizumab and adalimumab in biologic-naïve patients with active psoriatic arthritis: efficacy and safety outcomes from a randomized, open-label, blinded assessor study through 52 weeks. Arthritis Rheumatol. 2019;71(suppl 10). 2019 ACR/ARP Annual Meeting abstract L20. doi:10.1002/art.41108 9. Data on file. Lilly USA, LLC. DOF-IX-US-0165. 10. Data on file. Lilly USA, LLC. DOF-IX-US-0204. 11. Data on file. Lilly USA, LLC. DOF-IX-US-0226.