Psoriasis Area and Severity Index response in moderate-severe psoriatic patients switched to adalimumab: results from the OPPSA study.

BACKGROUND: Few studies have compared the efficacy of switching to adalimumab in the real-life setting in plaque psoriasis patients. OBJECTIVE: To evaluate the effect of adalimumab in psoriasis patients previously treated with other biologics. METHODS: In this multicentre study, psoriasis patients (N = 262) treated with an anti-TNF-alpha agent, ustekinumab or naïve to biologics then switched to adalimumab were included. Disease severity was assessed by the Psoriasis Area and Severity Index (PASI) at baseline and after 3, 6, 12, 24 and 36 months. The association between clinical risk factors and achievement of PASI response was evaluated by logistic regression. RESULTS: Adalimumab treatment resulted in a decrease in PASI (15.1 ± 6.2 at baseline vs. 2.7 ± 4.8 at 6 months, P < 0.0001), regardless of previous biologic treatment. Furthermore, adalimumab allowed 92.5%, 79% and 56% of patients to achieve PASI response (PASI 50, 75 and 90, respectively) and complete remission (PASI 100 response) in 48.4% of patients, by 6 months and maintained over 3 years, independent of prior biologic treatment. The absence of metabolic syndrome, dyslipidemia, hypertension and lower PASI and lower age at baseline was associated with achievement of PASI response at 3, 6 and 12 months, whereas at later time points (24 and 36 months), PASI 90 and PASI 100 response was associated with diagnosis of psoriasis/psoriatic arthritis. CONCLUSION: Adalimumab was effective at reducing PASI score over 3 years, irrespective of whether patients were biologic naïve or previously treated with a TNF-alpha or IL-12/23 inhibitor.

Improvement of psoriatic onychodystrophy by a water-soluble nail lacquer.

BACKGROUND: There is a strong need for effective products, simple to use and safe for a chronic use in the management of nail psoriasis. Recently, a non-drug, water-soluble nail lacquer became available, containing hydroxypropyl chitosan (HPCH), horsetail extract (Equisetum arvense) and methylsulphonyl-methane (DMSO(2)). This product was effective in strengthening the nails and reducing fragility and roughness in brittle nails. A clinical trial was performed to verify whether this product was able to improve nail psoriatic signs and appearance. PATIENTS AND METHODS: Thirty adult patients affected by mild to moderate symmetric psoriasis of the matrix and/or of the nail bed in at least one fingernail diagnosed more than 6 months before screening and with negative mycology findings were recruited. The nail lacquer was applied once daily on the affected fingernails of the left hand for 24 consecutive weeks. The right hand was used as control. The extent and severity of nail psoriasis was assessed on a target fingernail by means of the recently proposed Nail Psoriasis Severity Index (NAPSI) score. The value at baseline was 2.83 (+/- 0.99). At the end of treatment, the patients judged the treatment effect and their willing to continue product application. Adverse events were carefully recorded. RESULTS: Overall, 28 patients were included in the efficacy analysis. At the end of treatment, results showed a 72% reduction in pitting, 66% reduction in leukonychia, 63% reduction in onycholysis and a reduction of 65% in NAPSI score compared to baseline, respectively. No changes were observed in the untreated nails. Patients' treatment evaluation was classified as very satisfying or good by 78.6% of patients. The acceptability of the treatment was excellent in all patients both for the easiness and for the organoleptic characteristics of the product and 75% of them decided to continue the application after the end of the study. No adverse reactions were reported. CONCLUSION: In our experience, the new water-soluble nail lacquer proved to be effective in decreasing signs and symptoms of nail dystrophy in psoriatic patients. The effect was particularly evident on NAPSI and on pitting. The product was very well accepted by the patients.

A multicenter open-label experience on the response of psoriasis to Adalimumab and effect of dose escalation in non-responders: the Aphrodite project.

There is much evidence to show the efficacy of adalimumab, a human monoclonal antibody targeting tumour necrosis factor-alpha, in the treatment of plaque psoriasis. In this open-label experience, 147 high-need patients suffering from plaque psoriasis, with a mean Psoriasis Area and Severity Index (PASI) of 18.8, and concomitant psoriatic arthritis (PsA) received subcutaneous injections of 40 mg of adalimumab every other week (EOW). This was actually the dosage regimen recommended for PsA, as the drug had not then been approved for psoriasis at the time of the patients enrolment. At week 12, an improvement of at least 50 percent of the PASI (PASI-50) was observed in 111 (77 percent) patients. Continuation of treatment in responders with adalimumab 40 mg EOW led to a sustained response, with the PASI-50 achieved by 97 percent of patients in the as-treated analysis at week 24 (PASI-75 in 82 percent and PASI-90 in 45 percent out of 109 patients who received EOW injections up to week 24). Thirty subjects who failed to attain the PASI-50 response at week 12 were treated with adalimumab 40 mg every week for a further 12 weeks. At week 24, 80 percent of these patients obtained a PASI-50 response after dose escalation. Tolerability was good in the majority of patients. Only two patients discontinued treatment because of an adverse event (repeated flu-like episodes and a pleuropericarditis of unknown origin, respectively).

Influence of body mass index, comorbidities and prior systemic therapies on the response of psoriasis to adalimumab: an exploratory analysis from the APHRODITE data.

Adalimumab is a fully human monoclonal antibody directed against tumor necrosis factor (TNF)-alpha, which is effective for the treatment of psoriasis and psoriatic arthritis (PsA). The aim of this study is to determine whether the response of psoriasis to adalimumab treatment might be influenced by certain particular factors, such as body mass index (BMI), history of biologic therapy, blood hypertension and metabolic comorbidities. For this reason, an exploratory analysis was conducted on 144 patients with psoriasis and concomitant PsA treated with adalimumab 40 mg every other week, evaluating the influence of such factors on the Psoriasis Area and Severity Index (PASI) response rate at week 12. Our preliminary results suggest that the response rate at week 12, in terms of both PASI-50 and PASI-75, appeared to be independent of the presence of hypertension and/or metabolic comorbidities. The PASI-50 response was observed more frequently in patients with BMI less than 30 as compared to obese patients (79% vs 58%, p = 0.02). Previous use of anti-TNF biologics did not appear to affect per se the rate of responders, although it was associated with a lower PASI-75 rate among responders.

Morpheaform extra-ocular sebaceous carcinoma.

BACKGROUND: Sebaceous carcinoma is an unusual, aggressive, malignant tumor derived from the epithelium of sebaceous glands. It may arise in ocular or extra-ocular sites and is often evident as an ulcerated or non-ulcerated cystic nodule measuring up to 8 cm in diameter. A significant number of extra-ocular sebaceous carcinomas have been associated with metastases and high mortality rate. METHODS AND RESULTS: We reviewed the literature in the context of our report of a 68-year-old woman who had a morpheaform plaque of the upper lip of 15 years duration, extending into the left naso-genal groove, which histologically also showed marked stromal fibrosis. Three years after excision, there were no signs of recurrence or metastases. CONCLUSIONS: This patient is unusual in clinical and histologic pattern, as a morpheaform appearance has only been described previously in only one sebaceous carcinoma. In addition, no metastatic disease 15 years after tumor onset is a fortunate and remarkable feature.

Classification of non-Hodgkin malignant lymphomas of the skin.

The authors subdivide the primary non-Hodgkin cutaneous malignant lymphomas into "proper" and "non-proper" types. "Proper" lymphomas are those which have in the skin their proper site of localization, and include mycosis fungoides, Pagetoid reticulosis, Baccaredda-Sézary syndrome and possibly lymphomatoid papulosis. They are T-cell lymphomas arising in the papillary dermis, characterized by epidermotropism, having a specific clinical feature in that they are unlikely to be simulated by other cutaneous malignant lymphomas. "Non-proper" lymphomas are those which do not usually arise in the skin, but in various other organs. They are B-, T- or null-cell lymphomas, arising in the middle dermis, infrequently epidermotropic, having a papular-nodular-tumoural clinical feature, which are indistinguishable clinically from other neoplastic types such as plasmacytoma and Hodgkin's disease. The three classifications of non-Hodgkin lymphomas most followed are not directly applicable to cutaneous lymphomas because some of the former are not primarily sited in the skin, and because a follicular morphology is infrequently seen in the latter. Whereas the first classification reported for cutaneous lymphomas utilized malignancy as a criterion, the present classification here proposed utilizes the propriety of the site of localization as the criterion for subdivision into "proper" and "non-proper" types.