Taltz ® (ixekizumab) injektion

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Taltz® ▼ (ixekizumab): Behandling av genital psoriasis

Effekt och säkerhet av ixekizumab hos patienter med måttlig till svår genital psoriasis ges nedan.

IXORA-Q Clinical Trial Information

  • The safety and efficacy of ixekizumab in patients with moderate-to-severe GP was evaluated in a phase 3, randomized, double-blind, placebo-controlled clinical trial (IXORA-Q).1

  • A brief description of the IXORA-Q trial design is presented in  .

The dosing schedule of the treatment arm PBO/IXE Q4W of IXORA-Q trial is not consistent with the approved dosing schedule for plaque psoriasis in the Taltz summary of product characteristics. Please refer to the Taltz summary of product characteristics for approved dosing. 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.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

    • 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).1,3

  • The 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.1,3

  • The major secondary endpoints included at week 12, the proportion of patients that

    • achieved overall sPGA (0,1)

    • experienced at least a 3-point improvement in the GPSS score Itch NRS, and

    • achieved a GenPs-SFQ item 2 score of 0 or 1.1

Results Through Week 52

Efficacy

  • Figure 1 below presents sPGA-G (0,1) response rate for the combined 12-week blinded treatment period and open-label treatment periods. 

  • In the blinded treatment period, the percentage of patients achieving clear or almost clear genital skin was significantly greater for ixekizumab as early as week 1.1

  • Additional efficacy results are provided in Figure 1.

Figure 1. IXORA-Q: sPGA-G (0,1) Response Rate Over 52 Weeks, NRI4

Abbreviations: IXE Q2W = ixekizumab every 2 weeks; IXE Q4W = ixekizumab every 4 weeks; NRI = nonresponder imputation; PBO = placebo; sPGA-G = static Physicians Global Assessment of Genitalia.

p<.01 vs PBO.

 ‡ p<.001 vs PBO.

Table 1. IXORA-Q: Efficacy Results at Week 12 and Week 52, Ixekizumab Combined Blinded and Open-Label Periods, NRI2,4,5

 

PBO
n (%)

IXE Q2W 
n (%)

PBO/IXE Q4W
n (%)

IXE Q2W/IXE Q4W
n (%)


Week 12

Week 52

Number of subjects 

N=74

N=75

N=65

N=75

sPGA-G (0,1)

6 (8)

55 (73)a

51 (79)

56 (75)

sPGA-G (0)

4 (5)

42 (56)a

38 (59)

45 (60)

sPGA (0,1) 

2 (3) 

55 (73)a

48 (74)

54 (72)

sPGA (0)

0

30 (40)a

29 (45)

35 (47)

Number of subjects with baseline GPSS Itch NRS score ≥3

N=60

N=62

N=51

N=62

GPSS genital itch (≥3 point improvement)

5 (8) 

37 (60)a

35 (69)

45 (73)

Number of subjects with baseline GenPs-SFQ Item 2 score ≥2

N=42

N=37

N=35

N=37

GenPs-SFQ (item 2 score 0 or 1) 

9 (21) 

29 (78)a 

27 (77)

28 (76)

Abbreviations: GenPs-SFQ = Genital Psoriasis Sexual Frequency Questionnaire; GPSS = Genital Psoriasis Symptoms Scale; IXE Q2W = ixekizumab every 2 weeks; IXE Q4W = ixekizumab every 4 weeks; NRI = nonresponder imputation; NRS = numeric rating scale; PBO = placebo; sPGA = static Physician Global Assessment; sPGA-G = static Physician Global Assessment of Genitalia. Data are n (%) unless otherwise specified.

a p<.001 vs PBO.

Safety

  • Overall, during the 12 week blinded treatment period of IXORA-Q, TEAEs occurred more frequently in the ixekizumab group (56%) than placebo (45%), but were not statistically significantly different between treatment groups.1

  • Table 2 lists the severity of TEAEs and TEAEs of special interest reported through week 12 for the placebo-controlled, blinded treatment period as well as the safety overview for all patients receiving at least 1 dose of ixekizumab in the blinded treatment period or the open-label treatment period through week 52. The authors concluded the safety outcomes of ixekizumab in IXORA-Q were consistent with the overall safety profile for ixekizumab from previous studies.1,3,4

Table 2. IXORA-Q: TEAEs Reported During the 12 Week Blinded Treatment Period and All Ixekizumab Exposures Through Week 521,4


12 Week Blinded Treatment Period

Through 52 Week

 

PBO
N=74
n (%) 

IXE Q2W
N=75
n (%) 

All IXEa
N=140
n (%)

Overall TEAEs

33 (45)

42 (56)

107 (76)

Mild

15 (20)

23 (31)

41 (29)

Moderate

15 (20)

18 (24)

58 (41)

Severe

3 (4)

1 (1)

8 (6)

SAE

1 (1)

0

8 (6)

Discontinuations due to AE

5 (7)

1 (1)

3 (2)

TEAEs of special interest 

Hepatic 

2 (3) 

3 (2)

Cytopenias

1 (1)

Infections

13 (18)

18 (24)

75 (54)

Allergic reactions/hypersensitivities

3 (4)

4 (5)

14 (10)

Injection-site reactions

2 (3)

8 (11)

23 (16)

Cerebrocardiovascular events

0

0

2 (1)

Malignancies

0

0

3 (2)

Depression

2 (3)

0

5 (4)

Inflammatory bowel disease

0

0

1 (1)

Abbreviations: AE = adverse event; IXE = ixekizumab; IXE Q2W = ixekizumab every 2 weeks following a 160 mg starting dose; PBO = placebo; SAE = serious adverse event; TEAE = treatment-emergent adverse event.

a Includes patients who received ≥1 dose of ixekizumab during the blinded treatment period or open-label treatment period.

Therapeutic Indication

Ixekizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.2

References

1. Ryan C, Menter A, Guenther L, et al. 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. http://dx.doi.org/10.1111/bjd.16736

2. Taltz [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

3. Ryan 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.

4. Guenther 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.

5. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

BSA = body surface area

GenPs-SFQ = genital psoriasis sexual frequency questionnaire

GP = genital psoriasis

GPSS = genital psoriasis symptom scale

NRS = numeric rating scale

sPGA = static Physician Global Assessment

sPGA-G = static Physician Global Assessment of Genitalia

TEAE = treatment-emergent adverse event

Appendix A:  Clinical Trials Brief Description

Figure 2. IXORA-Q: Study Design4

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 (not consistent with approved dosing schedule according to Taltz summary of product characteristics).

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.

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Datum fӧr senaste ӧversyn 2019 M12 06


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