Safety and effectiveness of ixekizumab in Japanese patients with psoriasis vulgaris, psoriatic arthritis, generalized pustular psoriasis, and erythrodermic psoriasis: Post-marketing surveillance

Abstract

We report findings from a post-marketing study conducted from November 2016 to September 2022, which evaluated the safety and effectiveness of ixekizumab in Japanese patients with psoriasis under routine clinical practice for up to 52 weeks, and the incidence of serious infections and malignancies for up to 3 years. Of 804 patients in this analysis (67.9% male; median age, 54 years; mean disease duration, 11.8 years), 72.9%, 37.7%, 7.8%, and 3.7% had psoriasis vulgaris, psoriatic arthritis, pustular psoriasis, and erythrodermic psoriasis, respectively (subtypes not mutually exclusive). At 52 weeks, adverse events were reported in 203 patients (25.3%). Serious adverse events were reported in 36 patients (4.5%), including serious infections and infestations (n = 13, 1.6%). The incidence of serious infections and benign, malignant, and unspecified neoplasms was 0.8% (n = 5) and 0.6% (n = 4) respectively, at 3 years. Overall, 137 patients (17.0%) received Q2/Q2 treatment (160 mg starting dose, followed by 80 mg every 2 weeks from week 12); 550 patients (68.4%) received Q2/Q4 treatment (160 mg starting dose, followed by 80 mg every 2 weeks from weeks 2 to 12 and 80 mg every 4 weeks thereafter); and 117 patients (14.6%) discontinued before week 12 or received only one dose after week 12. A higher proportion of patients in the Q2/Q2 group had psoriatic arthritis (56.9% [n = 78]) compared with the Q2/Q4 group (32.9% [n = 181]). Among patients in the Q2/Q2 versus the Q2/Q4 dose groups, 21 (15.3%) and 141 (25.6%) respectively had adverse events and 2 (1.5%) and 32 (5.8%) respectively had serious adverse events. The mean Psoriasis Area and Severity Index score and body surface area percentage significantly decreased from baseline to week 52 for all psoriasis subtypes and by Q2/Q2 and Q2/Q4 ixekizumab doses (p < 0.01 or p < 0.001). Overall, the safety and effectiveness of ixekizumab in real-world settings in Japan were similar to those reported in clinical trials.

Keywords: ixekizumab; post‐marketing; psoriasis; safety; treatment effectiveness.

FIGURE 1

Study flowchart. AE, adverse event; CRF, case report form; Q2/Q2, an initial ixekizumab dose of 160 mg, followed by 80 mg every 2 weeks from week 12; Q2/Q4, an initial ixekizumab dose of 160 mg, followed by 80 mg every 2 weeks from week 2 to 12 and 80 mg every 4 weeks thereafter.

FIGURE 2

Treatment persistence of ixekizumab treatment in Japanese patients up to week 52 by disease type: (a) psoriasis vulgaris, (b) psoriatic arthritis, (c) pustular psoriasis, and (d) erythrodermic psoriasis. CI, confidence interval.

FIGURE 3

Effectiveness of ixekizumab treatment by disease type. Time course of Psoriasis Area and Severity Index (PASI) scores from baseline to week 52 by disease type: (a) psoriasis vulgaris, (b) psoriatic arthritis, (c) pustular psoriasis, and (d) erythrodermic psoriasis. Missing values were not imputed, but the last observations were carried forward for the last visit data of the effectiveness endpoint. *p < 0.05; **p < 0.01; ***p < 0.001 (t test).

FIGURE 4

Effectiveness of ixekizumab treatment by dose. Time course of Psoriasis Area and Severity Index (PASI) scores from baseline to week 52 in the (a) overall population and by ixekizumab, (b) Q2/Q2, and (c) Q2/Q4 dose. The percentage of patients achieving PASI 75 and PASI 90 by ixekizumab dose from baseline to week 52 in the (d) overall population and by (e) ixekizumab Q2/Q2 dose, and (f) Q2/Q4 dose. Data are shown as mean (standard deviation) in panels a–c and as mean percent in panels d–f. Missing values were not imputed, but the last observations were carried forward for the last visit data of the effectiveness endpoint. Q2/Q2, an initial ixekizumab dose of 160 mg, followed by 80 mg every 2 weeks from week 12; Q2/Q4, an initial ixekizumab dose of 160 mg, followed by 80 mg every 2 weeks from weeks 2 to 12 and 80 mg every 4 weeks thereafter.

FIGURE 5

Effectiveness of ixekizumab treatment. Time course of body surface area (BSA) from baseline to week 52 in (a) the overall population and by ixekizumab, (b) Q2/Q2, and (c) Q2/Q4 dose. Disease Activity Score in 28 joints using C‐reactive protein (DAS28‐CRP) by ixekizumab dose in patients with psoriatic arthritis in (d) the overall population and by ixekizumab doses in (e) Q2/Q2, and (f) Q2/Q4 dose. Patient‐reported quality of life assessed via the Dermatology Life Quality Index (DLQI) (g) in the overall population and by (h) Q2/Q2 and (i) Q2/Q4 ixekizumab dose. Data are shown as mean (standard deviation). Q2/Q2, an initial ixekizumab dose of 160 mg, followed by 80 mg every 2 weeks from week 12; Q2/Q4, an initial ixekizumab dose of 160 mg, followed by 80 mg every 2 weeks from week 2 to 12 and 80 mg every 4 weeks thereafter. **p < 0.01; ***p < 0.001 (t test).