Rapid and sustained improvements in Generalized Pustular Psoriasis Physician Global Assessment scores with spesolimab for treatment of generalized pustular psoriasis flares in the randomized, placebo-controlled Effisayil 1 study.

BACKGROUND: Effisayil 1 was a randomized, placebo-controlled study of spesolimab, which is an anti-IL-36 receptor antibody, in patients presenting with a generalized pustular psoriasis flare. OBJECTIVE: To assess the effects of spesolimab over the 12-week study. METHODS: The primary endpoint of the study was Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation subscore of 0 at week 1. Patients (N = 53) were randomized (2:1) to receive a single intravenous dose of 900 mg spesolimab or placebo on day 1. Patients could receive open-label spesolimab for persistent flare symptoms on day 8. RESULTS: Most patients receiving spesolimab achieved a GPPGA pustulation subscore of 0 (60.0%) and GPPGA total score of 0 or 1 (60.0%) by week 12. In patients randomized to placebo who received open-label spesolimab on day 8, the proportion with GPPGA pustulation subscore of 0 increased from 5.6% at day 8 to 83.3% at week 2. No factors predictive of spesolimab response were identified in patient demographics or clinical characteristics. LIMITATIONS: The effect of initial randomization was not determined conventionally beyond week 1 due to patients receiving open-label spesolimab. CONCLUSION: Rapid control of generalized pustular psoriasis flare symptoms with spesolimab was sustained over 12 weeks, further supporting its potential use as a therapeutic option for patients.

Sustainability and switching of biologics for psoriasis and psoriatic arthritis at Fukuoka University Psoriasis Registry.

Biologics are efficacious for treating psoriasis vulgaris (PsV) and psoriatic arthritis (PsA), but sometimes must be terminated or changed for various reasons including ineffectiveness or adverse events. To find the optimal choice of biologics for treating psoriasis, we analyzed the real-world data on drug survival and the reason for terminating or switching biologics. Medical records from patients with PsV or PsA, who visited the Department of Dermatology, Fukuoka University Hospital from 2010 to 2017, were analyzed. Two hundred and eleven patients received biologics, and 147 patients (69.7%) were treated with only one biologic, while 64 patients (30.3%) were switched to different products. Frequently used biologics in PsV were ustekinumab (UST), infliximab and adalimumab when calculated by patient-year. Tumor necrosis factor inhibitor (TNFi) use decreased while UST and interleukin (IL)-17 inhibitors increased in newly introduced patients. UST showed the highest survival rate as a first-line drug, but the advantage was lost in the second reagent's group. The major reasons for terminating/switching biologics were as follows: primary ineffectiveness (26.4%), secondary loss of efficacy (36.5%), patient's preference, including referral to nearby hospital, or stopped visiting (22.6%), side-effects (7.7%), comorbidities (3.4%) and economic burden (2.4%). In PsA patients, TNFi are more frequently employed than in PsV patients, although switching to UST or IL-17 inhibitors showed an increasing trend. Biologic reagents were changed mostly because of primary or secondary loss of efficacy, which affected drug survival. Further research is needed to find the optimal choice of biologics with larger samples at multiple facilities.

Asian consensus on assessment and management of mild to moderate plaque psoriasis with topical therapy.

A working group of dermatologists in Asian countries assessed the current status of psoriatic management in the region to prepare a consensus report on topical treatment in mild to moderate plaque psoriasis. Even though the association of psoriasis with systemic comorbidities is increasingly acknowledged, psoriasis is still lower in health-care priority lists in the region. The psychosocial impact of psoriasis may be greater in Asian countries due to cultural norms and social discrimination. Non-adherence to treatment is also common among Asians. The current care given to patients with mild to moderate psoriasis needs to be streamlined, enhanced and organized with a patient-centered care approach to achieve better outcomes. A comprehensive assessment of the disease severity and its impact on a patient's life is required before initiating treatment. Education and active involvement of the patient in the treatment plan is an important part of psoriatic management. It is recommended to personalize topical treatment to meet the needs of the patient, depending on disease severity, psychosocial impact, the patient's expectations and, more importantly, the patient's willingness and ability to actively follow the treatment procedure. Fixed-dose combination of corticosteroid and vitamin D analogs is the preferred topical medication for both initial and maintenance phases of treatment. The fast containment of the disease is the goal of the initial phase of 4-8 weeks and it demands a potent fast-acting topical therapy. Satisfactory control of the disease and prevention of relapses should be achieved during the maintenance phase with twice a week or weekend applications.

Assessment of medication adherence and treatment satisfaction in Japanese patients with psoriasis of various severities.

Psoriasis is a chronic, relapsing, inflammatory keratotic skin disease. To elucidate the medication adherence and treatment satisfaction, we performed a questionnaire survey using the eight-item Morisky Medication Adherence Scale (MMAS-8) and nine-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) of 163 psoriatic patients who regularly visited hospitals or clinics. To assess the relationship between the MMAS-8/TSQM-9 outcomes and severity of psoriasis, two different clinical severity indices were used: the Psoriasis Area and the Severity Index (PASI) for disease severity and the Psoriasis Disability Index (PDI) for quality of life (QOL) impairment. The MMAS-8 score for oral medication was significantly higher than that for topical medication. The oral and topical MMAS-8 scores were significantly correlated with the PDI score, but not with the PASI score, indicating that QOL impairment lowered treatment motivation. All of the TSQM-9 domain scores (effectiveness, convenience and global satisfaction) were significantly correlated with both the PASI and PDI scores, suggesting that patients whose skin and QOL conditions were under good control had high satisfaction with treatment. Patients treated with biologics had higher satisfaction than those treated with non-biologics.

Number needed to treat and costs per responder among biologic treatments for moderate-to-severe plaque psoriasis in Japan.

BACKGROUND: Biologics have been shown to improve the outcomes of patients with psoriasis but their cost is an issue. OBJECTIVE: Determine the number needed to treat (NNT) to achieve a 75%/90% reduction in the Psoriasis Area and Severity Index (PASI-75/90) and evaluate the incremental cost per PASI-75/90 responder (CPR) relative to placebo in Japan. METHODS: A network meta-analysis was conducted to estimate the relative probabilities of achieving PASI-75/90 and NNTs. Drug costs were assessed based on Pharmaceutical and Medical Device Agency-approved dosing. The CPR was estimated for a short-term induction period and first year of treatment. RESULTS: Compared with placebo, the PASI-75 NNT was 1.27 for adalimumab 80 mg, 1.29 for secukinumab 150 mg, 1.36 for secukinumab 300 mg, 1.57 for adalimumab 40 mg, 1.68 for ustekinumab 90 mg, 1.97 for ustekinumab 45 mg and 2.00 for infliximab 5 mg/kg. The short-term PASI-75 CPR relative to placebo was $5,062 for secukinumab 150 mg, $8209 for adalimumab 40 mg, $10,654 for secukinumab 300 mg, $11,754 for adalimumab 80 mg, $15,407 for ustekinumab 45 mg, $19,147 for infliximab 5 mg/kg and $26,257 for ustekinumab 90 mg. A similar ranking was observed for one-year PASI-75 CPRs and PASI-90 NNTs and CPRs. CONCLUSION: Adalimumab 40 mg/80 mg and secukinumab 150 mg/300 mg were the most efficacious and cost-efficient for patients with psoriasis in Japan.

Treatment satisfaction, willingness to pay and quality of life in Japanese patients with psoriasis.

There is a range of psoriasis treatments available, from topical applications to biologic therapy, with corresponding cost variations. The efficacy of each treatment is usually evaluated by objective measures such as the Psoriasis Area and Severity Index (PASI) or subjective measures such as the Dermatology Life Quality Index (DLQI). However, the social and economic impacts of psoriasis, including cost-effectiveness, have not been assessed in Japan. The EuroQol 5-Dimension (EQ-5D) is a generic instrument used worldwide to calculate quality-adjusted life years, on which calculations of treatment cost-effectiveness are based. We conducted a pilot study to determine the cost-effectiveness of psoriasis treatment in Japan. We administered a questionnaire to 133 patients with psoriasis (105 men and 28 women) who visited four university hospitals in Fukuoka Prefecture. The questionnaire covered medical costs, satisfaction and willingness to pay (WTP), and we investigated the relationships between these items. PASI was evaluated by physicians. More participants indicated satisfaction with treatment in the group paying less than ¥5000/month. WTP, PASI and EQ-5D showed little correlation. However, the DLQI and EQ-5D showed a moderate correlation (r = 0.472). WTP seemed more dependent on participants' economic backgrounds. We found that it was difficult to reflect the PASI with the EQ-5D. However, the DLQI may be used to estimate the cost-benefit relationship in patients with psoriasis. This is the first study to evaluate the EQ-5D in patients with psoriasis in Japan.