Safety and effectiveness of secukinumab in psoriasis vulgaris and psoriatic arthritis: Real‐world evidence in Japan

Abstract

Secukinumab, a fully human monoclonal antibody that selectively neutralizes interleukin‐17A, has been available for the treatment of moderate to severe psoriasis and psoriatic arthritis since February 2015 in Japan. Because there was a time gap after the previous approval of biologics for psoriatic disease indication, it was suggested that patients to be treated with secukinumab at its launch might have refractory disease symptoms. In order to assess the safety and effectiveness of secukinumab in those patients, a 52‐week, open‐label, multicenter, observational cohort study was conducted. In total, 306 and 250 patients were included in the safety and effectiveness analysis sets, respectively. Over half of patients had previously received biologics (56.9%). Adverse events, serious adverse events and adverse reactions were reported in 41.2%, 7.2% and 24.2% of patients, respectively. The most commonly reported adverse reactions were oral candidiasis (2.9%), consistent with those reported in clinical studies. In addition, none of the patient characteristics assessed for the effect on safety of secukinumab increased the occurrence of adverse reactions. Psoriasis Area and Severity Index score (mean ± standard deviation) improved from baseline (14.7 ± 12.3) to week 12 (1.78 ± 3.3), which was maintained up to week 24 (1.59 ± 3.0). The proportion of patients with a Dermatology Life Quality Index score of 0/1 improved from baseline (2.2%) to week 12 (64.7%) and sustained up to week 24 (71.4%). In addition to the skin symptoms, improvement was observed in all psoriatic arthritis disease‐related assessments. The current study reaffirmed the safety and effectiveness of secukinumab with broader patients than those in the clinical studies.

Secukinumab Demonstrated High Effectiveness in Vietnamese Patients with Moderate-To-Severe Plaque Psoriasis in a Real-World Clinical Setting: 16 Week Results from an Observational Study

“…In the current study, 81.1%, of Vietnamese patients achieved the primary endpoint of PASI 75, consistent with the findings reported in pivotal trials (67.0-81.6%) [7][8][9] as well as in regional real-world studies ([ 80.3-83%) [15,20]. PASI 90 and 100 response (68.9% and 36.5%) were also consistent with earlier trials (PASI 90 = 62-65.7%; PASI 100 = 44.5) [15,20].…”

“…The clinical effectiveness of secukinumab demonstrated in our ITT population was complemented by the improvement in QoL, with 66.1% patients achieving DLQI 0/1 by week 16, similar to values observed in other real-world studies (61.2-71.9%) [9,14,15]. QoL was improved in line with clinical efficacy, reaching a plateau at around week 12.…”

“…Failure of prior biologic therapies was demonstrated to be a response modifier in Japanese and Spanish patients [15,20]. However, this was not a reported parameter in the current study.…”

“…However, this was not a reported parameter in the current study. Patients recruited in this Vietnamese real-world study had shorter mean disease duration (7.9 years) compared with a realworld study reported previously [15,22] but had overall more severe disease, as indicated by the baseline PASI score (21.9) versus the two realworld Spanish trials (12.5-13.5) [20,22]. Higher absolute PASI at baseline may be an indicator that most patients in the current study had no prior systemic therapies.…”

“…This, in turn, might affect the treatment outcomes of secukinumab in the real-world clinical setting. The real-world effectiveness and safety of secukinumab were demonstrated in the PRO-SPECT study as well as in Japanese and Taiwanese populations [11,[13][14][15]. Epidemiology data suggest that PsO is more prevalent in Vietnam (2.2%) than in Taiwan (0.2%) and Japan (0.3%) [16][17][18].…”