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.

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
US_cFAQ_IXE417_GENITAL_PsO_SCALES_PRO_PsO
en-US

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
  • 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
    • labia majora, labia minora, and perineum in females, and
    • penis, scrotum, and perineum in males.2,3
  • 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
IXORA-Q: Genital Psoriasis Scales for Patient-Reported Outcomes

Scale

Question

Minimum Rating

Maximum Rating

GPSS5

Numeric ratings on: 
Itch, Pain, Discomfort, Stinging, Burning, Redness, Scaling, and Cracking

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

IXORA-Q: Total GPSS Score Change From Baseline Through Week 12, ITT Population, MMRM4

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 

IXORA-Q: GenPS-SFQ Item 2 Score (0,1) Through 12 Weeks, NRI, ITT Population With Baseline GenPs-SFQ Item 2 Score of ≥29

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
IXORA-Q: DLQI Item 9 Score (0,1) at Weeks 12 and 52, NRI10

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

IXORA-Q: GPSIS Avoidance and Impact Subscale Scores (1,2) at Weeks 12 and 52, Patients With Baseline Scores ≥3, NRI10

Abbreviations: GPSIS = Genital Psoriasis Sexual Impact Scale; IXE = ixekizumab; NRI = nonresponder imputation; PBO = placebo; Q2W = every 2 weeks; Q4W = every 4 weeks.

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

IXORA-Q: Study Design11

Abbreviations: IXE = ixekizumab; IXE Q2W = ixekizumab every 2 weeks; IXE Q4W = ixekizumab every 4 weeks; PBO = placebo.

Given as two 80 mg subcutaneous injections at week 0. Patients assigned to PBO received 2 subcutaneous injections of PBO at week 0.

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


Contact Lilly

Call Us

If you need information about a Lilly product or want to report an Adverse Event or Product Complaint, you may call us.

Available Mon - Fri, 9am - 7pm EST

Or you can

Chat with us

Chat with us

Submit a Request

Visit Us @LillyMedical