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Taltz ® (ixekizumab) injection
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TALTZ® (ixekizumab): Genital Psoriasis Scales and Patient Reported Outcomes
Ixekizumab showed significant efficacy vs placebo in a variety of outcome measures in genital psoriasis.
US_cFAQ_IXE417_GENITAL_PsO_SCALES_PRO_PsO
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Clinical Trial Information
- Patients with flexural, inverse, or GP 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.1
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 GP.2
- Appendix A: Clinical Trial Brief Description briefly describes the IXORA-Q trial design.
- The objective of the clinical trial was to evaluate the efficacy of ixekizumab vs placebo in patients with moderate-to-severe GP during 12 weeks of treatment.2
- 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
- sPGA-G ≥3
- sPGA ≥3
- BSA involvement ≥1%, and
- failure to respond or intolerance to at least 1 topical therapy for GP (corticosteroids, calcineurin inhibitors, or vitamin D analogues).2,3
- 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 NRS (a component of GPSS total score), and
- achieved a GenPs-SFQ item 2 score of 0 or 1.2
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 GP response to ixekizumab treatment in the IXORA-Q trial. No analyses included in this response other than GenPs-SFQ item 2 score (0,1) at week 12 were gated.2
- “Sexual Activity” was not limited to sexual intercourse and included activities such as masturbation.4
Scale |
Question |
Minimum Rating |
Maximum Rating |
GPSS5 |
Numeric ratings on: Also includes a total score (range 0-80) |
0, “none” |
10, “worst imaginable” |
GenPs-SFQ item 26 |
“In the past week, how often did your genital psoriasis limit the frequency of your sexual activity?” |
0, “never” |
4, “always” |
DLQI item 94 |
“In the past week, how much has your skin caused any sexual difficulties?” |
0, “not at all” |
3, “very much” |
GPSIS-avoidance4 |
“In the past week, how often did you avoid sexual activity because of your genital psoriasis symptoms?” |
1, “never” |
5, “always” |
GPSIS-impact4 |
“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” |
Abbreviations: DLQI = Dermatology Life Quality Index; GenPs-SFQ = Genital Psoriasis Sexual Frequency Questionnaire; GPSIS = Genital Psoriasis Sexual Impact Scale; GPSS = Genital Psoriasis Symptom 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 improvement in 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.4
- Ixekizumab was superior to placebo in improving all individual GPSS components within 1 week and through 12 weeks.7
Abbreviations: GPSS = Genital Psoriasis Symptom Scale; ITT = intent to treat; IXE Q2W = 80 mg ixekizumab 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).8
Genital Psoriasis Sexual Frequency Questionnaire
Significantly more patients treated with ixekizumab achieved GenPs-SFQ item 2 score (0,1) (indicating GP never or rarely limited sexual activity) at week 12 for patients with a GenPs-SFQ item 2 score of ≥2 at baseline (see IXORA-Q: GenPS-SFQ Item 2 Score (0,1) Through 12 Weeks, NRI, ITT Population With Baseline GenPs-SFQ Item 2 Score of ≥2).2
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.
Dermatology Life Quality Index Item 9
- Patients receiving ixekizumab showed a significant improvement in DLQI item 9 score (0,1) from week 2 through week 12.4
- 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.10
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 improvement in GPSIS-avoidance (1,2) from week 4 through week 12.4,9
- Among patients who were sexually active, there was a significant improvement in GPSIS-impact (1,2) at weeks 2, 4, and 8 but not week 12.4
- 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.10
Abbreviations: GPSIS = Genital Psoriasis Sexual Impact Scale; IXE = ixekizumab; NRI = nonresponder imputation; PBO = placebo; Q2W = every 2 weeks; Q4W = every 4 weeks.
Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Gordon 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
2Ryan 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
3Ryan 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.
4Yosipovitch 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
5Gottlieb 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
6Gottlieb 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
7Yosipovitch 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
8Guenther 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:adv00006. https://dx.doi.org/10.2340/00015555-3353
9Cather 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. https://server.aad.org/eposters/Submissions/getFile.aspx?id=5935&type=sub
10Ryan 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.
11Guenther L, Potts Bleakman A, Weisman J, et al. Persistent clinical improvement in genital psoriasis through one year of treatment with ixekizumab: results of a randomized, placebo-controlled phase 3 clinical trial in patients with moderate-to-severe genital psoriasis (IXORA-Q). Poster presented at: 77th Annual Meeting of the American Academy of Dermatology; March 1-5, 2019; Washington, D.C.
Glossary
BSA = body surface area
DLQI = Dermatology Life Quality Index
GenPs-SFQ = genital psoriasis sexual frequency questionnaire
GP = genital psoriasis
GPSIS = Genital Psoriasis Sexual Impact Scale
GPSS = genital psoriasis symptom scale
NRS = numeric rating scale
sPGA = static Physician Global Assessment
sPGA-G = static Physician Global Assessment of Genitalia
Appendix A: Clinical Trial Brief Description
Abbreviations: IXE = ixekizumab; IXE Q2W = ixekizumab every 2 weeks; IXE Q4W = ixekizumab every 4 weeks; PBO = placebo.
a Given as two 80 mg subcutaneous injections at week 0. Patients assigned to PBO received 2 subcutaneous injections of PBO at week 0.
b Option to step up to IXE Q2W at weeks 24, 28, and 40.
c At week 12, patients in the IXE Q2W group received 1 dose of ixekizumab 80 mg and 1 dose of placebo; patients in the PBO group received 2 doses of ixekizumab 80 mg.
Date of Last Review: February 05, 2021
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