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Taltz ® (ixekizumab) injection
80 mg/mL
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
What is the efficacy of Taltz® (ixekizumab) in genital psoriasis patient-reported outcome measures?
Ixekizumab showed significant efficacy vs placebo in a variety of genital psoriasis patient-reported outcome measures.
Genital Psoriasis Scales and Outcomes in IXORA-Q
IXORA-Q: Genital Psoriasis Scales for Patient-Reported Outcomes explains the scales and specific scale items utilized to measure secondary outcomes in genital psoriasis response to ixekizumab treatment in the IXORA-Q trial. No analyses included in this response other than Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) item 2 score (0,1) at week 12 were gated.1
“Sexual Activity” was not limited to sexual intercourse and included activities such as masturbation.2
Scale |
Question |
Minimum Rating |
Maximum Rating |
GPSS3 |
Numeric ratings on: Also includes a total score (range 0-80) |
0, “none” |
10, “worst imaginable” |
GenPs-SFQ item 24 |
“In the past week, how often did your genital psoriasis limit the frequency of your sexual activity?” |
0, “never” |
4, “always” |
DLQI item 92 |
“In the past week, how much has your skin caused any sexual difficulties?” |
0, “not at all” |
3, “very much” |
GPSIS-avoidance2 |
“In the past week, how often did you avoid sexual activity because of your genital psoriasis symptoms?” |
1, “never” |
5, “always” |
GPSIS-impact2 |
“In the past week, how would you rate the level (degree) of worsening of your genital psoriasis symptoms during or following sexual activity?” |
1, “very low or not at all” |
5, “very high” |
TA NRS5 |
"Over the past two weeks, have you avoided touching others or others touching you (for example, shaking hands or hugging) because of the way your skin looks or feels?" |
1-3, "low" |
7-10, "high" |
Abbreviations: DLQI = Dermatology Life Quality Index; GenPs-SFQ = Genital Psoriasis Sexual Frequency Questionnaire; GPSIS = Genital Psoriasis Sexual Impact Scale; GPSS = Genital Psoriasis Symptom Scale; TA NRS = touch avoidance numeric rating scale.
Note: “Sexual Activity” was not limited to sexual intercourse and includes activities such as masturbation.
Genital Psoriasis Symptom Scale
Ixekizumab treatment led to a significant (p<.001) improvement in Genital Psoriasis Symptoms Scale (GPSS) total score vs placebo within 1 week and through 12 weeks as shown in IXORA-Q: Total GPSS Score Change From Baseline Through Week 12, ITT Population, MMRM.2
Ixekizumab was superior to placebo in improving all individual GPSS components within 1 week and through 12 weeks.6
Figure 1 description: Ixekizumab treatment led to a significant (p<.001) improvement in GPSS total score LSM change from baseline vs placebo within 1 week and through 12 weeks.
Abbreviations: GPSS = Genital Psoriasis Symptoms Scale; ITT = intent-to-treat; IXE Q2W = ixekizumab 80 mg every 2 weeks; LSM = least squares mean; MMRM = mixed models repeated measure analysis; PBO = placebo.
‡ p<.001 vs PBO.
The mean (SD) change from baseline in total GPSS through week 52 was -30.8 (22.1) in patients continuously treated with ixekizumab from weeks 0 through 52 (n=75).7
Genital Psoriasis Sexual Frequency Questionnaire
Significantly (p<.001) more patients treated with ixekizumab achieved GenPs-SFQ item 2 score (0,1) at week 12 compared with placebo in patients with a GenPs-SFQ item 2 score of ≥2 at baseline (IXORA-Q: GenPS-SFQ Item 2 Score (0,1) Through 12 Weeks, NRI, ITT Population With Baseline GenPs-SFQ Item 2 Score of ≥2). A score of 0 or 1 for GenPs-SFQ item 2 indicates that genital psoriasis never or rarely limited sexual activity.1
Figure 2 description: Significantly more patients treated with ixekizumab achieved GenPs-SFQ item 2 score (0,1) at week 12 compared with placebo in patients with a GenPs-SFQ item 2 score of ≥2 at baseline.
Abbreviations: GenPs-SFQ = Genital Psoriasis Sexual Frequency Questionnaire; ITT = intent to treat; IXE Q2W = 80 mg ixekizumab every 2 weeks; NRI = nonresponder imputation; PBO = placebo.
* p<.05; † p<.01; ‡ p<.001.
In patients continuously treated with ixekizumab (n=75), 76% achieved GenPS-SFQ item 2 score (0,1) at week 52.7
Dermatology Life Quality Index Item 9
Patients receiving ixekizumab showed a significant (p<.001) improvement in Dermatology Life Quality Index (DLQI) item 9 score (0,1) from week 2 through week 12 vs placebo.2
As shown in IXORA-Q: DLQI Item 9 Score (0,1) at Weeks 12 and 52, NRI, response rates for patients achieving DLQI item 9 scores of 0 or 1 at week 12 persisted through 52 weeks of treatment with ixekizumab.9,10
Figure 3 description: Of patients receiving the approved ixekizumab dosing regimen in IXORA-Q, 92% achieved DLQI item 9 score of 0 or 1 at week 12 and 85% at week 52.
Abbreviations: DLQI = Dermatology Life Quality Index; IXE = ixekizumab; NRI = nonresponder imputation; PBO = placebo; Q2W = every 2 weeks; Q4W = every 4 weeks.
Genital Psoriasis Sexual Impact Scale
Patients receiving ixekizumab showed a significant (p<.01) improvement in Genital Psoriasis Sexual Impact Scale (GPSIS) avoidance (1,2) from week 4 through week 12.2,8
Among patients who were sexually active, there was a significant (p<.05) improvement in GPSIS impact (1,2) at weeks 2, 4, and 8 but not at week 12.2
As shown in IXORA-Q: GPSIS Avoidance and Impact Subscale Scores (1,2) at Weeks 12 and 52, Patients With Baseline Scores ≥3, NRI, response rates for patients achieving avoidance and impact subscale scores of 1 or 2 at week 12 persisted through 52 weeks of treatment with ixekizumab.9,10
Figure 4 description: Of patients receiving the approved ixekizumab dosing regimen in IXORA-Q, 77% achieved GPSIS avoidance score of 1 or 2 at week 12 and 80% at week 52. Additionally, 86% achieved GPSIS impact score of 1 or 2 at week 12 and 71% at week 52.
Abbreviations: GPSIS = Genital Psoriasis Sexual Impact Scale; IXE = ixekizumab; NRI = nonresponder imputation; PBO = placebo; Q2W = every 2 weeks; Q4W = every 4 weeks.
Touch Avoidance Numeric Rating Scale
As shown in IXORA-Q: Touch Avoidance Numeric Rating Scale, Mean Change From Baseline, patients treated continuously with ixekizumab maintained response at week 52 (-4.4 [3.2]) and patients originally assigned to placebo who then received open-label ixekizumab were able to attain a similar response by week 52 (-4.1 [3.6]).5
Figure 5 description: In the IXORA-Q, at the end of week 52, the mean change from baseline in touch avoidance numeric rating scale for patients treated continuously with ixekizumab was -4.4 compared to -4.1 for patients treated with placebo then switched to ixekizumab.
Abbreviations: mBOCF = modified baseline observation carried forward; IXE = ixekizumab; PBO = placebo; Q2W = every 2 weeks; Q4W = every 4 weeks; TA NRS = touch avoidance numeric rating scale.
a Patients had the option to increase dosing to IXE Q2W at weeks 24, 28, and 40, which was maintained to week 52.
As shown in IXORA-Q: Complete Resolution of Touch Avoidance Numeric Rating Scale, at the end of the week 52, 78.0% of patients treated continuously with ixekizumab every 2 weeks/every 4 weeks achieved complete resolution of touch avoidance, compared to 62.5% of patients who were originally assigned to placebo then switched to ixekizumab every 4 weeks.5
Figure 6 description: In the IXORA-Q at the end of week 52, 78.0% of patients treated continuously with ixekizumab achieved touch avoidance numeric rating scale score of zero, compared to 62.5% of patients treated with placebo then switched to ixekizumab.
Abbreviations: IXE = ixekizumab; NRI = nonresponder imputation; PBO = placebo; Q2W = every 2 weeks; Q4W = every 4 weeks; TA NRS = touch avoidance numeric rating scale.
a Patients had the option to increase dosing to IXE Q2W at weeks 24, 28, and 40, which was maintained to week 52.
Clinical Trial Information
Patients with flexural, inverse, or genital psoriasis were not excluded from the pivotal ixekizumab phase 3 clinical trials for psoriasis (UNCOVER-1, -2, and -3). However, presence or absence of flexural, inverse, or genital involvement and data regarding severity and improvement were not measured in these trials.11
IXORA-Q
A phase 3, randomized, double-blind, placebo-controlled clinical trial (IXORA-Q) evaluated the safety and efficacy of ixekizumab in patients with moderate-to-severe genital psoriasis.1
The objective of the clinical trial was to evaluate the efficacy of ixekizumab vs placebo in patients with moderate-to-severe genital psoriasis during 12 weeks of treatment.1
Key inclusion criteria included
- male or female patients at least 18 years of age
- chronic plaque psoriasis for at least 6 months
- plaque psoriasis in a non-genital area
- static Physician's Global Assessment of Genitalia (sPGA-G) score ≥3
- static Physician's Global Assessment (sPGA) score ≥3
- body surface area (BSA) involvement ≥1%, and
- failure to respond or intolerance to at least 1 topical therapy for genital psoriasis (corticosteroids, calcineurin inhibitors, or vitamin D analogues).1,12
The gated primary endpoint was the proportion of patients at week 12 that achieved clear or minimal psoriasis severity in the genital region [sPGA-G (0,1)] including
The major gated secondary endpoints included at week 12, the proportion of patients that
- achieved overall sPGA (0,1)
- experienced at least a 3-point improvement in genital psoriasis itch numeric rating scale (a component of GPSS total score), and
- achieved a GenPs-SFQ item 2 score of 0 or 1.1
Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Ryan C, Menter A, Guenther L, et al; the IXORA‐Q Study Group. Efficacy and safety of ixekizumab in a randomized, double-blinded, placebo-controlled phase IIIb study of patients with moderate-to-severe genital psoriasis. Br J Dermatol. 2018;179(4):844-852. https://dx.doi.org/10.1111/bjd.16736
2Yosipovitch G, Foley P, Ryan C, et al. Ixekizumab improved patient-reported genital psoriasis symptoms and impact of symptoms on sexual activity vs placebo in a randomized, double-blind study. J Sex Med. 2018;15(11):1645-1652. http://dx.doi.org/10.1016/j.jsxm.2018.09.004
3Gottlieb AB, Kirby B, Ryan C, et al. The development of a patient-reported outcome measure for assessment of genital psoriasis symptoms: the Genital Psoriasis Symptoms Scale (GPSS). Dermatol Ther (Heidelb). 2018;8(1):45-56. https://dx.doi.org/10.1007/s13555-017-0213-2
4Gottlieb AB, Kirby B, Ryan C, et al. The development of the genital psoriasis sexual frequency questionnaire (GenPs-SFQ) to assess the impact of genital psoriasis on sexual health. Dermatol Ther (Heidelb). 2018;8(1):33-44. http://dx.doi.org/10.1007/s13555-017-0212-3
5Soung J, Cather JC, Gooderham M, et al. Improvement in general touch avoidance in patients with moderate-to-severe genital psoriasis treated with ixekizumab during a 52-week, randomized, phase 3 clinical trial (IXORA-Q). JEACP. 2023;2(2):282-292. https://doi.org/10.1002/jvc2.126
6Yosipovitch G, Foley P, Burge R, et al. Ixekizumab provides rapid and greater improvement of the symptoms of genital psoriasis compared to placebo in a randomized, double-blind, phase 3b clinical trial. J Am Acad Dermatol. 2018;79(3):AB174. https://doi.org/10.1016/j.jaad.2018.05.709
7Guenther L, Potts Bleakman A, Weisman J, et al. Ixekizumab results in persistent clinical improvement in moderate-to-severe genital psoriasis during a 52 week, randomized, placebo-controlled, phase 3 clinical trial. Acta Derm Venereol. 2020;100(1):adv00006. https://doi.org/10.2340/00015555-3353
8Cather JC, Meeuwis K, Burge R, et al. Ixekizumab provides greater improvement versus placebo on the impact of genital psoriasis on sexual activity for patients with moderate-to-severe genital psoriasis in a randomized, double-blind phase 3b clinical trial. Poster presented at: 76th Congress of the American Academy of Dermatology; February 16-20, 2018; San Diego, CA.
9Ryan C, Foley P, Burge R, et al. Persistence of improvement in sexual impact associated with moderate-to-severe genital psoriasis for up to 52 weeks of treatment with ixekizumab. Poster presented at: 28th Annual Meeting of the European Academy of Dermatology and Venereology; October 9-13, 2019; Madrid, Spain.
10Ryan C, Guenther L, Foley P, et al. Ixekizumab provides persistent improvements in health-related quality of life and the sexual impact associated with moderate-to-severe genital psoriasis in adult patients during a 52-week, randomized, placebo-controlled, phase 3 clinical trial. J Eur Acad Dermatol Venereol. 2022;36(4):e277-e279. https://dx.doi.org/10.1111/jdv.17836
11Gordon KB, Blauvelt A, Papp KA, et al; UNCOVER-1, UNCOVER-2, and UNCOVER-3 Study Groups. Phase 3 trials of ixekizumab in moderate-to-severe plaque psoriasis. N Engl J Med. 2016;375(4):345-356. http://dx.doi.org/10.1056/NEJMoa1512711
12Ryan C, Menter A, Guenther L, et al. Efficacy and safety of ixekizumab in a randomized, double-blinded, placebo-controlled, phase 3b clinical trial in patients with moderate-to-severe genital psoriasis. Poster presented at: 26th Congress of the European Academy of Dermatology and Venereology (EADV); September 13-17, 2017: Geneva, Switzerland.
Date of Last Review: January 26, 2023