Om du vill rapportera en biverkning gällande en av Lillys produkter, kontakta oss via e-post på DK_PHv@lilly.com eller på telefon +45 4526 6040. Har du ytterligare medicinska frågor gällande en av Lillys produkter, kontakta oss via länken ovan.
Taltz ® (ixekizumab) injektion
Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska
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 Appendix A: Clinical Trials Brief Description.
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
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
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.
Table 1. IXORA-Q: Efficacy Results at Week 12 and Week 52, Ixekizumab Combined Blinded and Open-Label Periods, NRI2,4,5
|
PBO |
IXE
Q2W |
PBO/IXE
Q4W |
IXE
Q2W/IXE Q4W |
|
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.
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 |
IXE
Q2W |
All
IXEa |
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) |
0 |
3 (2) |
Cytopenias |
0 |
0 |
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
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.
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 (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.
Datum fӧr senaste ӧversyn 2019 M12 06