Safety profiles and efficacy of infliximab therapy in Japanese patients with plaque psoriasis with or without psoriatic arthritis, pustular psoriasis or psoriatic erythroderma: Results from the prospective post‐marketing surveillance

Abstract

A large-scale prospective post-marketing surveillance was conducted to evaluate the safety and efficacy of infliximab in Japanese patients with plaque psoriasis, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma. This study was conducted in all psoriasis patients treated with infliximab after its Japanese regulatory approval. Infliximab was administrated at 5 mg/kg at weeks 0, 2 and 6, and every 8 weeks thereafter. Patients were serially enrolled and observed for 6 months to evaluate the safety and efficacy. The safety and efficacy were evaluated in 764 and 746 patients, respectively. Incidences of any and serious adverse drug reactions were 22.51% and 6.94%, respectively, and those of any and serious infusion reactions were 6.15% and 1.31%, respectively, which were comparable with the results in the post-marketing surveillance with 5000 rheumatoid arthritis patients in Japan. Major adverse drug reactions during the follow-up period were infections (5.10%) including pneumonia, cellulitis and herpes zoster, however, no tuberculosis was observed. The safety profiles were equivalent, regardless of the psoriasis types. No new safety problems were identified. The response rates on global improvement and median improvement rate of Psoriasis Area and Severity Index in all patients were 88.0% and 85.0%, respectively. Of note, the efficacy was equivalent for each psoriasis type as well as for each body region. Infliximab was also effective in pustular psoriasis symptoms, joint symptoms and nail psoriasis, as well as improvement of quality of life. Infliximab was confirmed to be highly effective and well tolerated in treating refractory psoriasis, including pustular psoriasis and psoriatic erythroderma.

Efficacy and safety of dose escalation of infliximab therapy in Japanese patients with psoriasis: Results of the SPREAD study

“…However, we could not clarify whether elevated serum IFX level by dose escalation resulted in increased AE or not, because serum IFX level in onset time of each AE was not evaluated. In contrast, the incidences of AE, SAE and infections in this study were similar to those reported in Japanese post-marketing surveillance of standard-dose of IFX therapy, 17 and the safety profiles were consistent with those in previous studies, 8,9 raising no new safety concerns. In addition, no correlation of trough serum IFX level with occurrence of AE was observed in this study.…”

Cardiovascular and Metabolic Diseases Comorbid with Psoriasis: Beyond the Skin

“…IL-17A promotes the expression of TNF-α by keratinocytes (19), which indicates that the above-mentioned TNF-α/IL-23/IL-17 axis likely forms a vicious loop in the development of psoriasis lesions (Figure). The mechanistic hypothesis coincides with the fact that antibodies against TNF-α, IL-23(p19), IL-23(p40), IL-23R, IL-17A or IL-17RA exert remarkable clinical effects on psoriasis both in Caucasian and Asian ethnicities (8, 22-31). In contrast, the decisive pathogenic roles of IL-12, IFN-γ and IL-22 in psoriasis remain elusive, as clinical trials of the anti-IL-12 p35-p40 antibody (SMART), anti-IFN-γ antibody (HuZAF) and anti-IL-22 antibody (fezakinumab) have been discontinued (8).…”

Japanese guidance for use of biologics for psoriasis (the 2019 version)

“…Table 1 shows the list of biologics available for psoriasis in Japan. In the References section, the following are listed as sources for efficacy and safety data in pivotal studies of each biologic in and outside of Japan and for the results of Japanese post-marketing surveillance of each biologic: infliximab, [7][8][9][10][11][12][13][14][15][16] adalimumab, 17-23 ustekinumab, 24-32 secukinumab, [33][34][35][36][37][38][39][40][41][42] ixekizumab, [43][44][45][46][47][48] brodalumab, [49][50][51][52][53][54] guselkumab, 55-61 risankuzumab 62-64 and infliximab BS. 65,66 Additional note: Psoriasis arthropathica and psoriatic arthritis.…”