Patient Story
Consider the possibilities with Taltz
Think Taltz for your patients with
axSpA (AS and nr-axSpA)
Michelle’s Story (PsA)
Michelle* has psoriatic arthritis. She needs a treatment that offers powerful and consistent efficacy over time.
Daniel’s Story (axSpA)
Daniel* has axSpA. He needs a treatment that provides powerful and consistent efficacy, regardless of diagnosis (AS or nr-axSpA).
Consider the possibilities with Taltz
“My treatment doesn’t seem to be working consistently.”
What type of patient is a candidate for Taltz?
- Still experiencing spinal pain and morning stiffness
- Inconsistent response on current NSAIDs and asking for better results
- Desires fast and lasting relief of symptoms
Needs a treatment that provides powerful and consistent efficacy regardless of diagnosis (nr-axSpA or AS)
*Hypothetical patient profile.
IMPROVEMENT IN SIGNS AND SYMPTOMS OF axSpA:
COAST-X (nr-axSpA, Biologic-naive): See ASAS40 response rates through week 52
SELECT IMPORTANT SAFETY INFORMATION: CONTRAINDICATIONSTaltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.
COAST-V (AS, Biologic-naive): See ASAS40 results in as fast as 16 weeks and maintained through week 52
FOR BIOLOGIC-NAIVE PATIENTS WITH AS
Rapid ASAS40 response rate at week 16 maintained through week 521,2
Primary endpoint=ASAS40 at week 16.
The extended treatment period of the study (weeks 16 to 52) has limitations (ie, no placebo comparison, patients remaining in the extension phase may be those more responsive to Taltz treatment).
NRI of ITT population through weeks 16 and 52.
AS=ankylosing spondylitis; ASAS40=Assessment of Spondyloarthritis International Society response criteria, ≥40% improvement; NRI=nonresponder imputation; ITT=intent-to-treat.
SELECT IMPORTANT SAFETY INFORMATION: INFECTIONSTaltz 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.
Humira® is a registered trademark of AbbVie Biotechnology Ltd.
COAST-W (AS, TNFi-experienced): See ASAS40 results in as fast as 16 weeks and maintained through week 52
FOR TNFi-EXPIERIENCED PATIENTS WITH AS
Rapid ASAS40 response rate at week 16 maintained through week 521-3
Primary endpoint=ASAS40 at week 16.
The extended treatment period of the study (weeks 16 to 52) has limitations (ie, no placebo comparison, patients remaining in the extension phase may be those more responsive to Taltz treatment).
NRI of ITT population through weeks 16 and 52.
AS=ankylosing spondylitis; ASAS40=Assessment of Spondyloarthritis International Society response criteria, ≥40% improvement; TNFi=tumor necrosis factor inhibitor; NRI=nonresponder imputation; ITT=intent-to-treat.
PRE-TREATMENT EVALUATION FOR TUBERCULOSISEvaluate 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.
COAST-X (nr-axSpA, Biologic-naive): See ASAS40 response rates through week 52
FOR BIOLOGIC-NAIVE PATIENTS WITH nr-axSpA
Significant improvement in nr-axSpA symptoms achieved through week 521,7,8
Primary endpoint=ASAS40 at week 52.
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 either switched to Taltz 80 mg Q2W, were missing week 16 or week 52 data, or discontinued double-blind treatment were considered nonresponders. Taltz 80 mg Q2W is not an approved dose for nr-axSpA.
In a post hoc analysis of the patients in the Q4W arm that switched to open-label therapy (n=40), 25% had achieved ASAS40 at the last visit before switching; these patients were counted as non-responders in the primary outcome analysis at week 52.8
NRI of ITT population through weeks 16 and 52.
nr-axSpA=non-radiographic axial spondyloarthritis; ASAS40=Assessment of Spondyloarthritis International Society response criteria, ≥40% improvement; NRI=nonresponder imputation; Q2W=every 2 weeks; Q4W=every 4 weeks; ITT=intent-to-treat.
SELECT IMPORTANT SAFETY INFORMATION: HYPERSENSITIVITYSerious 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.
References: 1. Taltz [package insert]. Indianapolis, IN: Lilly USA, LLC. 2. Dougados M, Cheng-Chung Wei J, Landewé R, et al; COAST-V Study Group; COAST-W Study Group. Efficacy and safety of ixekizumab through 52 weeks in two phase 3, randomised, controlled clinical trials in patients with active radiographic axial spondyloarthritis (COAST-V and COAST-W). Ann Rheum Dis. 2020;79:176-185. 3. Deodhar A, Poddubnyy D, Pacheco-Tena C, et al; COAST-W Study Group. Efficacy and safety of ixekizumab in the treatment of radiographic axial spondyloarthritis: sixteen-week results from a phase III randomized, double-blind, placebo-controlled trial in patients with prior inadequate response to or intolerance of tumor necrosis factor inhibitors. Arthritis Rheumatol. 2019;71:599-611. 4. Data on file. Lilly USA, LLC. DOF-IX-US-0162. 5. van der Heijde D, Cheng-Chung Wei J, Dougados M, et al; COAST-V Study Group. Ixekizumab, an interleukin-17A antagonist in the treatment of ankylosing spondylitis or radiographic axial spondyloarthritis in patients previously untreated with biological disease-modifying anti-rheumatic drugs (COAST-V): 16 week results of a phase 3 randomised, double-blind, active-controlled and placebo-controlled trial. Lancet. 2018;392:2441-2451. 6. Data on file. Lilly USA, LLC. DOF-IX-US-0157. 7. Data on file. Lilly USA, LLC. DOF-IX-US-0225. 8. Deodhar A, van der Heijde D, Gensler LS, et al; COAST-X Study Group. Ixekizumab for patients with non-radiographic axial spondyloarthritis (COAST-X): a randomised, placebo-controlled trial. Lancet. 2020;395:53-64.