JEADV: Ixekizumab can moderate to severe sexual effects related to genital psoriasis

It is reported that up to 63% of psoriasis patients suffer from genital psoriasis
.

It is often associated with severely impaired health-related quality of life (HRQoL), including the impact on sexual health is much greater than psoriasis without genital involvement.

Quality of Life

Ixekizumab (IXe) is a selective for interleukin -17A (IL-17A) of high affinity monoclonal antibodies, the US Food and Drug Administration Bureau ( the FDA the only treatment) approved by moderate to severe plaque Drugs for patients with psoriasis, including successful treatment of patients with genital damage
.

In the IXORA-Q trial, IXe significantly improved the effects of HRQOL and genetic effects on sex after 12 weeks of treatment

Manage FDA

149 patients participated in the induction period (0-12 weeks); patients were randomly assigned to placebo (PBO) or Ixekizumab (IXEQ2W); most people had a GPSIS impact score of ≥3 (moderate to very high), nearly three points One of the patients had a GPSIS avoidance score of 5 (always avoid sexual activity due to GenPs)
.

At week 12, 93% of patients (PBO: n=65; IXE Q2W: n=74) entered the open-label treatment period, in which all patients received IXE 80 mg every 4 weeks (Q4W) until week 52, and the initial PBO was randomized Patients receiving a starting dose of 160 mg IXE

In the 12th week, patients treated with IXe achieved continuous improvement in HRQL through DLQI(0,1) and SF-36 measurement in multiple areas, as well as the impact of genes on sex; these improvements have been Lasts until week 52
.

In the group (IXe/IXe) who received IXe treatment in both periods (IXe/IXe), the proportion of patients who responded to GPSIS avoidance (1, 2) continued until week 52, and 80% (n=24/30) of patients achieved GPSIS avoidance ( 1, 2)

SF-36

After converting from PBO to IXE, GPSIS avoidance (1, 2) response increased rapidly from 26% (n=9/35) (week 12) to 72% (n=21/29) (week 16) and 79% (n=23/29) (Week 52) (Figure 1A)
.

After converting from PBO to IXE, the GPSIS-Impact(1, 2) response increased rapidly from 53% (n=9/171) (12 weeks) to 94% (15/16) (16 weeks), and continued to 52 weeks (93%, n=13/14)

In the IXe/IXe population, 47% of patients reached DLQI (0, 1) at the 12th week and continued until the 52nd week (Figure 1C)
.

At 52 weeks, 85% of IXe/IXe patients completed DLQI item 9(0,1) (Figure 1D)

At week 12, IXe treatment resulted in a significantly greater average change in the 6 SF-36 areas (9) and physical composition summary (Table 1) than the baseline
.

After switching to IXEQ4W, the average change in the summary scores of all SF-36 areas and two components of the PBO/IXe group from baseline increased from week 12 to week 52

 

Figure 1.
GPSIS-Avoid (1, 2) and GPSIS-Impact (1, 2) results, and DLQI (0, 1) and DLQI item 9 (0, 1) response rates, up to 52 weeks IXORA-Q (no Respondents convicted [based on patients with GPSIS-Impact with Mx+PX1]), including blind T2T and open-label T2T
.

(A) The proportion of patients who reported that they never (1) or rarely (2) avoided sex due to genital psoriasis (GPSIS-avoidance [1, 2]) [Based on patients with baseline GPSIS-avoidance score ≥ 3] ; (B) Proportion of patients who reported low or no (1) or low (2) symptoms of genital psoriasis after sexual intercourse (GPSIS-Impact[1, 2]) [Based on baseline GPSIS-avoidance score Patients with ≥ 3]; (C) The proportion of patients with a score of (0, 1) in the total DLQI, indicating that it has no effect on HRQI; (D) The proportion of patients with a score of (0, 1) on DLQI item 9 Proportion, show'

Figure 1.
GPSIS-Avoid (1, 2) and GPSIS-Impact (1, 2) results, and DLQI (0, 1) and DLQI item 9 (0, 1) response rates, up to 52 weeks IXORA-Q (no Respondents convicted [based on patients with GPSIS-Impact with Mx+PX1]), including blind T2T and open-label T2T
.
(A) The proportion of patients who reported that they never (1) or rarely (2) avoided sex due to genital psoriasis (GPSIS-avoidance [1, 2]) [Based on patients with baseline GPSIS-avoidance score ≥ 3] ; (B) Proportion of patients who reported low or no (1) or low (2) symptoms of genital psoriasis after sexual intercourse (GPSIS-Impact[1, 2]) [Based on baseline GPSIS-avoidance score Patients with ≥ 3]; (C) The proportion of patients with a score of (0, 1) in the total DLQI, indicating that it has no effect on HRQI; (D) The proportion of patients with a score of (0, 1) on DLQI item 9 Proportion, show'
.
The dotted line separates the double-blind treatment period (0-12 weeks) and the open-label treatment period (12-52 weeks)
.

 

The results showed that patients treated with IXe achieved significant clinical improvement in GENS symptoms, HRQOL and the sexual impact of GEN, lasting for up to 1 year, supporting the IXORA-Q study and IXe as an effective treatment option for moderate to severe GEN The previous results
.

Source: Ryan C, Guenther L, Foley P, Ixekizumab provides persistent improvements in health-related quality of life and the sexual impact associated with moderate-to-severe genital psoriasis in adult patients during a 52-week, randomized, placebo-controlled , phase 3 clinical trial.
J Eur Acad Dermatol Venereol 2021 Nov 23;

Ryan C, Guenther L, Foley P, Ixekizumab provides persistent improvements in health-related quality of life and the sexual impact associated with moderate-to-severe genital psoriasis in adult patients during a 52-week, randomized, placebo-controlled, phase 3 clinical trial.
J Eur Acad Dermatol Venereol 2021 Nov 23;

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