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Taltz ® (ixekizumab) injektion
För fullständig produktresumé för Taltz® se
FASS.
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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.
SE_cFAQ_IXE374_TREATMENT_OF_GENITAL_PSORIASIS
en-GB
IXORA-Q Clinical Trial Information
- 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.1
- Appendix A: Clinical Trials Brief Description briefly describes the IXORA-Q trial design.
- 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 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 1.1
Results Through Week 52
Efficacy
- IXORA-Q: sPGA-G (0,1) Response Rate Over 52 Weeks, NRI 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
- IXORA-Q: Efficacy Results at Week 12 and Week 52, Ixekizumab Combined Blinded and Open-Label Periods, NRI provides additional efficacy results. No analyses other than those listed in IXORA-Q Clinical Trial Information were gated.1
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.
Week 12 |
Week 12 |
Week 52 |
Week 52 |
|
|
PBO |
IXE Q2W |
PBO/IXE Q4W |
IXE Q2W/IXE Q4W |
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 presented as n (%) unless otherwise specified.
ap<.001 vs PBO.
Time to Improvement
In a post hoc analysis of data from IXORA-Q, patients who were originally randomized to ixekizumab in the double-blind treatment period and entered the open-label treatment period had rapid improvements in
- genital skin
- genital itch resolution
- the impact of GP on frequency of sexual activity, and
- quality of life.6
The improvements in genital psoriasis and quality of life were sustained through week 52.6
Time to Improvement of Genital Psoriasis Outcomes in IXORA-Q in the Open-Label Treatment Population shows the median times to improvement of these outcomes.
Outcome |
Median (95% CI) Days |
Time to first sPGA-G (0,1) |
26 (16, 35) |
Time to first sPGA-G (0) |
59 (56, 86) |
Genital itch NRS improvement ≥4-point reductiona |
59 (34, 115) |
Genital itch NRS=0b |
50 (34, 73) |
GenPs-SFQ Item 2 (0,1)c |
22 (10, 28) |
DLQI (0,1) |
88 (81, 167) |
Abbreviations: DLQI = Dermatology Life Quality Index; GenPs-SFQ = Genital Psoriasis Sexual Frequency Questionnaire; NRS = numeric rating scale; sPGA-G = static Physician Global Assessment of Genitalia.
aIn those patients with genital itch NRS ≥4 at baseline.
bIn those patients with genital itch NRS ≥1 at baseline.
cIn those patients with GenPs-SFQ Item 2 ≥2 at baseline.
A post hoc analysis of data from IXORA-Q evaluated the effect of ixekizumab over 12 weeks on GP severity, pain, itch, and sexual health in those patients with or without genital erosions, fissures, or ulcers at baseline (n=57; 38% of study population).7
Effect on Secondary Lesions, Pain, and Sexual Health
A post hoc analysis of data from IXORA-Q evaluated the effect of ixekizumab over 12 weeks on GP severity, pain, itch, and sexual health in those patients with or without genital erosions, fissures, or ulcers at baseline (n=57; 38% of study population).7
In those patients with genital erosions, fissures, or ulcers at baseline in IXORA-Q
- 62% of patients who received ixekizumab and
- 25% of patients who received placebo
had complete resolution of these signs after 1 week.7
After 12 weeks, complete resolution of these signs were reported in
- 83% of patients who received ixekizumab and
- 21% of patients who received placebo.7
Compared with placebo, a significantly greater proportion of patients who received ixekizumab achieved a sPGA-G (0,1) response rate regardless of the presence or absence of genital erosions, fissures, and/or ulcers at baseline (p<.01 vs placebo in patients with these signs; p<.001 vs placebo in patients without these signs).7
The sPGA-G (0,1) response rates for patients who received ixekizumab were similar regardless of the presence or absence of genital erosions, fissures, and/or ulcers at baseline.7
Regardless of baseline presence or absence of genital erosions, fissures, and/or ulcers, compared with placebo, patients who received ixekizumab had a significantly greater improvement over 12 weeks of treatment in
- sPGA-G score (p<.0001 with or without baseline signs)
- mGPASI score (p<.0001 with or without baseline signs)
- GPSS total score (p<.001 with baseline signs; p=.01 without baseline signs)
- GPSS sum of pain, stinging, and burning (p<.001 with baseline signs; p=.008 without baseline signs), and
- GPSS itch NRS (p<.002 with baseline signs; p<.001 without baseline signs).7
Compared with placebo, a significantly greater proportion of patients who received ixekizumab achieved GenPs-SFQ item 2 (0,1) response regardless of presence or absence of genital erosions, fissures, and/or ulcers (p<.01 with baseline signs; p<.001 without baseline signs).7
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
- IXORA-Q: TEAEs Reported During the 12-Week Blinded Treatment Period and All Ixekizumab Exposures Through Week 52 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 52.1,3,8
- The authors concluded the safety outcomes of ixekizumab in IXORA-Q were consistent with the overall safety profile for ixekizumab from previous studies.1,3,8
12-Week Blinded Treatment Period |
Through 52 Weeks |
||
|
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) |
Candidiasis |
0 |
0 |
7 (5) |
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.
aIncludes patients who received ≥1 dose of ixekizumab during the blinded treatment period or open-label treatment period.
References
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
2Taltz [summary of product characteristics]. Eli Lilly and Company (Ireland) Limited, Ireland
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.
4Guenther 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
5Data on file, Eli Lilly and Company and/or one of its subsidiaries.
6Merola JF, Guenther L, Foley P, et al. Speed of improvement in genital psoriasis, genital itch, sexual impact, and health-related quality of life in patients with moderate-to-severe genital psoriasis treated with ixekizumab. Poster presented at: 2020 American Academy of Dermatology Virtual Meeting Experience; June 12-14, 2020.
7Merola JF, Ghislain PD, Dauendorffer JN, et al. Ixekizumab improves secondary lesional signs, pain and sexual health in patients with moderate-to-severe genital psoriasis. J Eur Acad Dermatol Venereol. 2020;34(6):1257-1262. https://dx.doi.org/10.1111/jdv.16181
8Guenther 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
GenPs-SFQ = genital psoriasis sexual frequency questionnaire
GP = genital psoriasis
GPSS = genital psoriasis symptom scale
mGPASI = modified Genital Psoriasis Area and Severity Index
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
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 February 03, 2021