The Journal of dermatology
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Multicenter Study
Phase I study of pegylated interferon-alpha-2b as an adjuvant therapy in Japanese patients with malignant melanoma.
In the adjuvant setting for malignant melanoma, interferon (IFN)-α-2b and pegylated (PEG) IFN-α-2b were approved in several countries including the USA before these were approved in Japan. To resolve the "drug-lag" issue, this phase I study was designed to evaluate the safety and tolerability in Japanese patients with stage II or III malignant melanoma who had undergone surgery, by treating with PEG IFN-α-2b. As with a previously reported phase III study, patients were to receive PEG IFN-α-2b 6 μg/kg per week s.c. during an 8-week induction phase, followed by a maintenance phase at a dose of 3 μg/kg per week up to 5 years. ⋯ No neutralizing antibody was detected in these patient samples. PEG IFN-α-2b was tolerated in Japanese patients, and eventually approved in Japan in May 2015 for adjuvant therapy in patients with stage III malignant melanoma. Because the number of patients was limited, further investigation would be crucial.
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Multicenter Study Pragmatic Clinical Trial
Oral tofacitinib efficacy, safety and tolerability in Japanese patients with moderate to severe plaque psoriasis and psoriatic arthritis: A randomized, double-blind, phase 3 study.
Tofacitinib is an oral Janus kinase inhibitor that is being investigated for psoriasis and psoriatic arthritis. Japanese patients aged 20 years or more with moderate to severe plaque psoriasis and/or psoriatic arthritis were double-blindly randomized 1:1 to tofacitinib 5 or 10 mg b.i.d. for 16 weeks, open-label 10 mg b.i.d. for 4 weeks, then variable 5 or 10 mg b.i.d. to Week 52. Primary end-points at Week 16 were the proportion of patients achieving at least a 75% reduction in Psoriasis Area and Severity Index (PASI75) and Physician's Global Assessment of "clear" or "almost clear" (PGA response) for psoriasis, and 20% or more improvement in American College of Rheumatology criteria (ACR20) for patients with psoriatic arthritis. ⋯ Adverse events occurred in 83% of patients through Week 52, including four (4.3%) serious adverse events and three (3.2%) serious infections (all herpes zoster). No malignancies, cardiovascular events or deaths occurred. Tofacitinib (both doses) demonstrated efficacy in patients with moderate to severe plaque psoriasis and/or psoriatic arthritis through 52 weeks; safety findings were generally consistent with prior studies.
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Because nivolumab significantly prolongs survival in patients with metastatic melanoma, enhancing its antitumor immune response is of great interest to dermato-oncologists. In this report, we describe two cases of metastatic melanoma successfully treated with nivolumab in combination with contact immunotherapy, using contact sensitizing agents, such as squaric acid dibutylester and diphencyprone. In addition, immunohistochemical staining supported one of the possible mechanisms of this combination therapy. Our present cases suggested a possible therapy for metastatic melanoma using nivolumab in combination with contact immunotherapy.
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The early psoriatic arthritis screening questionnaire (EARP) is a simple and fast method for the identification of arthritis in patients with psoriasis. We established the Japanese version of the EARP (J-EARP) questionnaire, which includes 10 items with two choices for each. This study aimed to evaluate the utility of the J-EARP questionnaire. ⋯ The scores of the J-EARP questionnaire in early-stage PsA patients (<1 year from onset) were significantly higher than in those of psoriasis patients, but not lower than in those of later stage (≥1 year from onset) PsA patients. The J-EARP questionnaire is simple and fast to administer and has been proven to be robust for the identification of PsA. The J-EARP questionnaire is a useful diagnostic tool for early-stage PsA patients.
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Review Case Reports
Eccrine porocarcinoma shares dermoscopic characteristics with eccrine poroma: A report of three cases and review of the published work.
Eccrine porocarcinoma (EPC) is a rare malignant skin tumor presumably arising from the intraepidermal ductal portion of the sweat gland. EPC occasionally mimics eccrine poroma (EP), seborrhea keratosis (SK), basal cell carcinoma (BCC), pyogenic granuloma (PG) and amelanotic melanoma with its clinical appearance as a pink nodule. Dermoscopy is an invaluable technique in diagnosing skin tumors. ⋯ Our investigation revealed that the dermoscopic characteristic of EP was also observed in discrete areas of EPC lesions. Thus, it is possible that the histopathological architecture of EPC contains portions of benign EP-like components. Awareness of this dermoscopic aspect of EPC may be helpful when diagnosing pink nodules.