Efficacy
Taltz: Powerful and consistent results across PsA and axSpA
(AS, nr-axSpA)1-6
Power
- ONLY Taltz demonstrates superiority in a head-to-head trial against Humira® (adalimumab) in PsA2,3*
- ONLY Taltz achieves ASAS40 as a primary
endpoint in AS.1,4†
Consistency
- Sustained ACR20/50/70 results in PsA that lasted through 3 years1,5
- Established 52-week efficacy in axSpA with robust clinical trial program1,4,6
*36% of Taltz patients achieved the primary endpoint, simultaneous achievement of ACR50 and PASI 100 response at week 24, vs 28% of patients taking Humira (P<.05 vs Humira).
†48% of patients with AS taking Taltz in COAST-V achieved the primary endpoint, ASAS40 at week 16, vs 18% of patients receiving placebo (P<.0001 vs placebo).
Humira® is a registered trademark of AbbVie Biotechnology Ltd.
PsA=psoriatic arthritis; axSpA=axial spondyloarthritis; AS=ankylosing spondylitis; nr-axSpA=non-radiographic axial spondyloarthritis; ASAS40=Assessment of Spondyloarthritis International Society response criteria, ≥40% improvement; ACR20/50/70=American College of Rheumatology 20%/50%/70% response; PASI=Psoriasis Area Severity Index; PASI 100=100% improvement from baseline in PASI criteria.
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.
The first and only IL-17A antagonist to demonstrate superiority vs Humira in a PsA H2H trial
FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS
Superiority vs Humira at week 24: Simultaneous achievement of ACR50 and PASI 100 at week 24 with consistency through week 522,3
Primary endpoint=simultaneous achievement of ACR50 and PASI 100 at week 24.
All patients had BSA ≥3%; patients with BSA ≥10%, PASI ≥12, sPGA ≥3 followed the dosing for moderate to severe PsO.3
ACR50=American College of Rheumatology 50% response; PASI=Psoriasis Area Severity Index; PASI 100=100% improvement from baseline in PASI criteria; NRI=nonresponder imputation; BSA=body surface area; sPGA=static Physician’s Global Assessment; PsO=psoriasis.
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.
Powerful joint symptom relief regardless of TNFi experience
FOR ADULT PATIENTS WITH PSORIATIC ARTHRITIS
Powerful joint symptom results, regardless of TNFi experience1,7,8
Primary endpoint=ACR20 response at week 24.1
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.1
NRI of ITT population through week 24.
TNFi=tumor necrosis factor inhibitor; ACR20/50/70=American College of Rheumatology 20%/50%/70% response; NRI=nonresponder imputation; ITT=intent-to-treat; DMARD=disease-modifying antirheumatic drug.
FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS
Superiority vs Humira at week 24: Simultaneous achievement of ACR50 and PASI 100 at week 24 with consistency through week 522,3
Primary endpoint=simultaneous achievement of ACR50 and PASI 100 at week 24.
All patients had BSA ≥3%; patients with BSA ≥10%, PASI ≥12, sPGA ≥3 followed the dosing for moderate to severe PsO.3
ACR50=American College of Rheumatology 50% response; PASI=Psoriasis Area Severity Index; PASI 100=100% improvement from baseline in PASI criteria; NRI=nonresponder imputation; BSA=body surface area; sPGA=static Physician’s Global Assessment; PsO=psoriasis.
FOR ADULT PATIENTS WITH PSORIATIC ARTHRITIS
Taltz improved psoriatic skin lesions1,7-10
In SPIRIT-P1, among patients with sPGA ≥3 at baseline (Taltz 80 mg every 4 weeks n=52; placebo n=41), 75% of patients receiving Taltz achieved sPGA 0,1 at week 12 vs 7% of patients who received placebo. Additionally, 31% of patients receiving Taltz achieved sPGA 0 at week 12 vs 2% for placebo.
In SPIRIT-P2, 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.
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.1
Primary endpoint=ACR20 at week 24.
TNFi=tumor necrosis factor inhibitor; PASI=Psoriasis Area Severity Index; PsA=psoriatic arthritis; PsO=psoriasis; BSA=body surface area; NRI=nonresponder imputation; PASI 75/90/100=75%/90%/100% improvement from baseline in PASI criteria; ITT=intent-to-treat; sPGA=static Physician’s Global Assessment; ACR20=American College of Rheumatology 20% response.
SELECT IMPORTANT SAFETY INFORMATION: 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.
Discover Taltz SPIRIT-H2H trial data
Learn more about the primary endpoint data from a head-to-head trial against Humira
Presented by: Dr. Grace Wright
Improvement in patients with preexisting enthesitis in PsA
FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS
Taltz showed improvement in patients with preexisting enthesitis7-9,11
LEI=Leeds Enthesitis Index; NRI=nonresponder imputation; TNFi=tumor necrosis factor inhibitor; IR=inadequate responder.
FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS
Complete resolution of enthesitis (LEI=0) through year 31,11-13
A subset of patients from SPIRIT-P1 with enthesitis (LEI >0) at baseline (mean baseline score=2.8).11
Primary endpoint=ACR20 response at week 24.11
In an mNRI analysis of patients receiving Taltz, 57% of patients achieved LEI=0 at week 52, 55% at week 108, and 47% at week 156. mNRI of ITT population through week 156.
mNRI, a preferred method for analyzing long-term efficacy, imputes missing data due to study drug (eg, inadequate response, adverse event, lack of efficacy), as nonresponse; whereas missing data due to other reasons (eg, missed visits, lost to follow-up) are included as predicted values 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.1
The uncontrolled extension period of the study has limitations (eg, no placebo comparisons, patients remaining in the study may be those with better results).13
LEI=Leeds Enthesitis Index; ACR20=American College of Rheumatology 20% response; mNRI=modified nonresponder imputation; ITT=intent-to-treat.
FOR TNFi-EXPERIENCED PATIENTS WITH PSORIATIC ARTHRITIS
Complete resolution of enthesitis was maintained in the majority of patients through year 31,8,11,12,14-16
In SPIRIT-P2 (TNFi-experienced), in an mNRI analysis of patients receiving Taltz 80 mg every 4 weeks (n=68), 48% of patients achieved LEI=0 at week 52, 46% at week 108, and 38% at week 156.16
mNRI analysis, a preferred method for analyzing long-term efficacy, imputes missing data due to study drug (eg, inadequate response, adverse event, lack of efficacy), as nonresponse; whereas missing data due to other reasons (eg, missed visits, lost to follow-up) are included as predicted values based on statistical modeling of observed data.
Primary endpoint=ACR20 response at week 24.8
The uncontrolled extension period of the study has limitations (eg, no placebo comparisons, patients remaining in the study may be those with better results).
TNFi=tumor necrosis factor inhibitor; LEI=Leeds Enthesitis Index; mNRI=modified nonresponder imputation; ACR20=American College of Rheumatology 20% response.
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.
Proven to inhibit the progression of structural joint damage as early as week 16 in PsA
FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS
Taltz inhibited progression of structural joint damage in patients as early as week 16 vs placebo1,7,8,17
Primary endpoint=ACR20 response at week 24.
Inhibition of progression of structural damage was assessed radiographically and expressed as the adjusted mean change in mTSS and its components, the joint space narrowing score and bone erosion score, at week 16 vs baseline.
The mTSS score was modified for PsA by addition of hand distal interphalangeal joints.
SPIRIT-P2 (TNFi-experienced) did not include an assessment of radiographic progression.8
mTSS=modified total Sharp score; MMRM=mixed-effect model of repeated measure; ACR20=American College of Rheumatology 20% response; PsA=psoriatic arthritis; TNFi=tumor necrosis factor inhibitor.
FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS
The majority of Taltz patients had minimal progression* of structural joint damage through year 318,19
Any missing post-baseline mTSS data were imputed using linear extrapolation if patients had baseline and ≥1 post-baseline value (ie, week 52, 108, or 156). At week 156, 16.7% were linear extrapolated.
The data presented were from post hoc analyses and were not placebo-controlled; therefore, statistical conclusions cannot be drawn.
Week 156 mean mTSS change from baseline (linear extrapolation) was 1.7 (Nx=72) for patients entering the extension period and initially randomized to Taltz 80 mg every 4 weeks (n=81; mean baseline 19.7); median mTSS change from baseline was 0.
The open-label extension phase of the study has limitations (eg, no placebo comparison, patients remaining in the extension phase may be those with better results). Patients in the extension period population were all patients administered Taltz on or after week 24.
74% of Taltz patients had ≤.5 change from baseline in mTSS.
mTSS=modified total Sharp score; ACR20=American College of Rheumatology 20% response.
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.
ACR response rates achieved with or without MTX in PsA
FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS
Taltz may be administered alone or in combination with a conventional DMARD1,8,20,21
ACR20 response vs placebo with or without concomitant MTX*
Primary endpoint=ACR20 response at week 24.
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.
All patients were allowed to remain on stable background therapy.
The data presented were from post hoc analyses and were not type-I error–controlled; therefore, treatment differences between Taltz and placebo cannot be regarded as statistically significant.
*All patients in SPIRIT-P2 were previously treated with at least 1 conventional DMARD (MTX, sulfasalazine, leflunomide, or hydroxychloroquine).10,22
DMARD=disease-modifying antirheumatic drug;
ACR20=American College of Rheumatology 20% response;
MTX=methotrexate;
NRI=nonresponder imputation;
TNFi=tumor necrosis factor inhibitor.
FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS
Taltz vs Humira: ACR response rates with or without concomitant MTX at week 523,21
ACR response rates for patients with and without concomitant MTX were prespecified but not type-I error–controlled at week 24, and weeks 28 to 52 were post hoc analysis; therefore, results cannot be regarded as statistically significant.
Primary endpoint=simultaneous achievement of ACR50 and PASI 100 at week 24.3
ACR20/50/70=American College of Rheumatology 20%/50%/70% response; MTX=methotrexate; NRI=nonresponder imputation; ITT=intent-to-treat; TNFi=tumor necrosis factor inhibitor.
See SPIRIT-P1 and -P2 Trial Designs (PsA) See SPIRIT-H2H Trial Design (PsA)
SELECT IMPORTANT SAFETY INFORMATION: IMMUNIZATIONS
Prior to initiating Taltz, consider completion of all age-appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with Taltz.
Consistent joint symptom results sustained for 3 years in PsA
FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS
Consistent joint symptom results sustained for 3 years5,15
In an mNRI analysis of patients receiving Taltz, ACR20 results were 76% at week 52, 71% 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 of ITT population through week 156.
mNRI, a preferred method for analyzing long-term efficacy, imputes missing data due to study drug (eg, inadequate response, adverse event, lack of efficacy) as nonresponse; whereas missing data due to other reasons (eg, missed visits, lost to follow-up) are included as predicted values based on statistical modeling of observed data.
The uncontrolled extension period of the study has limitations (eg, no placebo comparisons, patients remaining in the study may be those with better results).
IRs (<20% improvement in tender and in swollen joint counts) at week 16 were analyzed as nonresponders after week 16 until the primary endpoint.
ACR20/50/70=American College of Rheumatology 20%/50%/70% response; mNRI=modified nonresponder imputation; ITT=intent to treat; IR=inadequate responder.
FOR TNFi-EXPERIENCED PATIENTS WITH PSORIATIC ARTHRITIS
Consistent joint symptom results sustained for 3 years in TNFi-experienced patients1,23
In SPIRIT-P2 (TNFi-experienced), in a modified mNRI analysis of patients receiving Taltz 80 mg every 4 weeks at week 52, 70% achieved ACR20, 47% achieved ACR50, and 29% achieved ACR70. At week 108, 60% achieved ACR20, 46% achieved ACR50, and 23% achieved ACR70. At week 156, 55% achieved ACR20, 40% achieved ACR50, and 23% achieved ACR70.1,24
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.
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.1
The uncontrolled extension period of the study has limitations (eg, no placebo comparisons, patients remaining in the study may be those with better results).
TNFi=tumor necrosis factor inhibitor; ACR20/50/70=American College of Rheumatology 20%/50%/70% response; mNRI=modified nonresponder imputation.
FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS
Complete resolution of enthesitis (LEI=0) through year 31,11-13
Primary endpoint=ACR20 response at week 24.11
In an mNRI analysis of patients receiving Taltz, 57% of patients achieved LEI=0 at week 52, 55% at week 108, and 47% at week 156. mNRI of ITT population through week 156.
mNRI, a preferred method for analyzing long-term efficacy, imputes missing data due to study drug (eg, inadequate response, adverse event, lack of efficacy), as nonresponse; whereas missing data due to other reasons (eg, missed visits, lost to follow-up) are included as predicted values 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.1
The uncontrolled extension period of the study has limitations (eg, no placebo comparisons, patients remaining in the study may be those with better results).13
LEI=Leeds Enthesitis Index; ACR20=American College of Rheumatology 20% response; mNRI=modified nonresponder imputation; ITT=intent-to-treat.
FOR TNFi-EXPERIENCED PATIENTS WITH PSORIATIC ARTHRITIS
Complete resolution of enthesitis was maintained in the majority of patients through year 31,8,11,12,14-16
In SPIRIT-P2 (TNFi-experienced), in an mNRI analysis of patients receiving Taltz 80 mg every 4 weeks (n=68), 48% of patients achieved LEI=0 at week 52, 46% at week 108, and 38% at week 156.16
mNRI analysis, a preferred method for analyzing long-term efficacy, imputes missing data due to study drug (eg, inadequate response, adverse event, 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.
Primary endpoint=ACR20 response at week 24.8
The uncontrolled extension period of the study has limitations (eg, no placebo comparisons, patients remaining in the study may be those with better results).
TNFi=tumor necrosis factor inhibitor; LEI=Leeds Enthesitis Index; mNRI=modified nonresponder imputation; ACR20=American College of Rheumatology 20% response.
SELECT IMPORTANT SAFETY INFORMATION: ADVERSE REACTIONSMost common adverse reactions (≥1%) associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections. Overall, the safety profiles observed in adult patients with psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and pediatric patients with plaque psoriasis were consistent with the safety profile in adult patients with plaque psoriasis, with the exception of influenza and conjunctivitis in psoriatic arthritis, and conjunctivitis, influenza, and urticaria in pediatric psoriasis.
Proven efficacy across the spectrum of axSpA (AS and nr-axSpA)
Powerful efficacy across the spectrum of axSpA (AS, nr-axSpA)1,6,24
First and only approved AS treatment that has ASAS40 as a primary endpoint in its label1
Approved for adults with nr-axSpA1
axSpA=axial spondyloarthritis; nr-axSpA=non-radiographic axial spondyloarthritis; AS=ankylosing spondylitis; ASAS40=Assessment of Spondyloarthritis International Society response criteria, ≥40% improvement.
FOR BIOLOGIC-NAIVE PATIENTS WITH ANKYLOSING SPONDYLITIS
The first and only approved AS treatment to achieve ASAS40 as a primary endpoint1,24-26
Primary endpoint=ASAS40 at week 16.
Patients with missing data were counted as nonresponders.
ASAS improvement criteria assess improvement in signs and symptoms of AS.
Criteria include spinal pain, physical function, global assessment, and inflammation.
NRI of ITT population through week 16.
Among biologic-naive patients, 64% receiving Taltz, 59% receiving Humira, and 40% receiving placebo achieved ASAS20 at week 16.
Additional week 16 results from COAST-W trial, NRI26
In COAST-W (TNFi-experienced) (Taltz 80 mg every 4 weeks n=114; placebo n=104), 25% of patients receiving Taltz achieved ASAS40 at week 16 vs 13% for placebo. Additionally, 48% of patients receiving Taltz achieved ASAS20 at week 16 vs 30% for placebo.
Additional results from COAST-X trial, NRI1,6,27
In COAST-X (biologic-naive) (Taltz 80 mg every 4 weeks n=96; placebo n=105), 35% of patients receiving Taltz achieved ASAS40 at week 16 vs 19% for placebo. Additionally, 30% of patients receiving Taltz achieved ASAS40 at week 52 vs 13% for placebo.1,6,27
Primary endpoint=ASAS40 at week 52.
In COAST-X, 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 non-responders. Taltz 80 mg Q2W is not an approved dose for nr-axSpA.
AS=ankylosing spondylitis; ASAS20/40=Assessment of Spondyloarthritis International Society response criteria, ≥20%/≥40% improvement; NRI=nonresponders imputation; ITT=intent-to-treat.
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.
An IL-17A antagonist to treat across the spectrum of axSpA
In this video, Dr. Parke discusses the role of IL-17A across the spectrum of axial spondyloarthritis and the trial results of Taltz in axSpA
Presented by: Dr. Frank Parke
References: 1. Taltz [package insert]. Indianapolis, IN: Lilly USA, LLC. 2. Data on file. Lilly USA, LLC. DOF-IX-US-0190. 3. 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. 4. 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. 5. Data on file. Lilly USA, LLC. DOF-IX-US-0013. 6. Data on file. Lilly USA, LLC. DOF-IX-US-0225. 7. Mease PJ, van der Heijde D, Ritchlin CT, et al; 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. 8. 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. Lancet. 2017;389:2317-2327. 9. 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-2 phase 3 trial. Supplementary material. Lancet. 2017;389:2317-2327. 10. Data on file. Lilly USA, LLC. TAL20171127A. 11. Data on file. Lilly USA, LLC. DOF-IX-US-0127. 12. Data on file. Lilly USA, LLC. DOF-IX-US-0151. 13. 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. 14. Data on file. Lilly USA, LLC. DOF-IX-US-0277. 15. Chandran V, van der Heijde D, Fleischmann RM, et al. Ixekizumab treatment of biologic-naïve patients with active psoriatic arthritis: 3-year results from a phase III clinical trial (SPIRIT-P1). Rheumatology (Oxford). 2020;59:2774-2784. 16. Orbai AM, Gratacós J, Turkiewicz A, et al. Efficacy and safety of ixekizumab in patients with psoriatic arthritis and inadequate response to TNF inhibitors: 3-year follow-up (SPIRIT-P2). Rheumatol Ther. 2021;8:199-217. 17. Data on file. Lilly USA, LLC. TAL20171026B. 18. van der Heijde D, Chandran V, Fleischmann R, Benichou O, Rathmann S, Shuler C. Radiographic progression of structural joint damage in patients with active psoriatic arthritis treated with ixekizumab for up to 3 years. Arthritis Rheumatol. 2018;70(suppl 10). 2018 ACR/ARHP Annual Meeting abstract 662. Accessed September 23, 2021. https://acrabstracts.org/abstract/radiographic-progression-of-structural-joint-damage-in-patients-with-active-psoriatic-arthritis-treated-with-ixekizumab-for-up-to-3-years 19. Data on file. Lilly USA, LLC. DOF-IX-US-0020. 20. Data on file. Lilly USA, LLC. TAL20170919A. 21. Data on file. Lilly USA, LLC. TAL20171026A. 22. Data on file. Lilly USA, LLC. DOF-IX-US-0192. 23. Data on file. Lilly USA, LLC. DOF-IX-US-0247. 24. 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. 25. Data on file. Lilly USA, LLC. DOF-IX-US-0155. 26. 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. 27. 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.