Real-Life Effectiveness of Apremilast for the Treatment of Psoriasis in Belgium: Results From the Observational OTELO Study.

INTRODUCTION: Apremilast is approved for the treatment of psoriasis and psoriatic arthritis. However, data on the efficacy and safety of apremilast in clinical practice are limited. We assessed the real-world use and effectiveness of apremilast in patients with moderate to severe plaque psoriasis visiting dermatologist practices in Belgium, from the perspectives of the patient and the physician. METHODS: This prospective observational study enrolled adults aged 18 years or more initiating apremilast between 6 April 2017 and 30 June 2018, per Belgian reimbursement criteria. Primary outcome was the Patient Benefit Index for Skin Diseases (PBI-S). Secondary outcomes included the Patient Global Assessment (PtGA), Dermatology Life Quality Index (DLQI), Psoriasis Area and Severity Index (PASI), and body surface area (BSA). Patients were followed up for up to 18 months. RESULTS: Overall, 122 enrolled patients received at least one dose of apremilast, of which 89 received treatment for more than 150 days and were included in the reference population. Treatment goals most frequently identified (at least 70% of patients) as "very important" in the PBI-S were related to physical impairments. After 6 months of apremilast treatment, 61-78% of patients reported they had achieved these goals; only 12.5% assessed their disease as severe (PtGA, 53.6% at apremilast initiation) and over half reported a DLQI score of 5 or less, indicating improved quality of life. As assessed by the physician, 68.4% and 35.1% of patients achieved at least a 50% and 75% reduction in PASI, respectively, at month 6. Apremilast was well tolerated with no new safety signals identified. CONCLUSIONS: Our real-world data indicate that apremilast fulfils the expectations of Belgian patients with moderate to severe psoriasis, and from the perspectives of both the patient and physician, apremilast has a positive impact on their disease. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03097003.

Recommendations for managing a suboptimal response to biologics for moderate-to-severe psoriasis: A Belgian perspective.

Over the past decade, biologics have become the gold standard in the treatment of moderate-to-severe psoriasis for patients who have failed or who have contraindications to traditional systemic treatments. However, although practical recommendations on how to treat a suboptimal response to biologics exist in other chronic inflammatory diseases, they are only just beginning to emerge for psoriasis. This article aims to formulate recommendations in the case of a suboptimal response of psoriasis to biologics in the Belgian setting. A Belgian taskforce of psoriasis experts was convened to review the results of a literature search and formulate recommendations based on the available evidence and provide expert opinion to address gaps in the evidence. The taskforce has proposed a treatment algorithm for patients with a primary non-response or a secondary loss of response to help address an unmet need. Expert recommendations have been developed to address treatment strategies in case of a primary or secondary suboptimal response to biologics in the treatment of moderate-to-severe psoriasis in Belgium.

A descriptive study of psoriasis characteristics, severity and impact among 3,269 patients: results of a Belgian cross sectional study (BELPSO).

BACKGROUND: Although several large observational studies have reported on psoriasis characteristics, very few have included severity assessments by dermatologists and validated health related quality of life measures. OBJECTIVE: To describe psoriasis characteristics, clinical severity and their impact on quality of life of patients diagnosed with psoriasis by a dermatologist. METHODS: From 2006 to 2007, 192 Belgian dermatologists examined psoriasis patients. Demographics, type of psoriasis, body sites affected, Psoriasis Area and Severity Index, Body Surface Area and Physician's Global Assessment were assessed. Patients answered questions concerning their psoriasis and completed the Dermatology Life Quality Index (DLQI), Skindex-17 and EQ-5D. RESULTS: Of the 3,629 psoriasis patients, more than three quarters had plaque psoriasis for more than 16 years. One fifth had nail involvement, 16% had affected genitals, 15% suffered from severe joint pain, 6.4% reported psoriatic arthritis diagnosed by a rheumatologist. Despite therapy, for 83% patients the clinical psoriasis severity was relatively high (mean PASI 8.5 and %BSA12). 40% of patients reported a substantial impact of psoriasis, according to the DLQI and Skindex-17 and the mean EQ-5D score was 0.76. CONCLUSION: Psoriasis patients consulting dermatologists present with relatively severe disease and often report a high impact on their physical and psychological well-being.

Histological and transcriptional study of angiogenesis and lymphangiogenesis in uninvolved skin, acute pinpoint lesions and established psoriasis plaques: an approach of vascular development chronology in psoriasis.

BACKGROUND: Dysregulation of angiogenesis and lymphangiogenesis could participate in psoriasis pathogenesis. Analysis of nascent psoriasis lesions should help at identifying early vascular anomalies. OBJECTIVE: To analyse vascular development, angiogenesis and lymphangiogenesis markers expression in uninvolved skin in psoriatic patients (N), early psoriasis lesions or pinpoints (PP) and psoriasis plaques (PSO). METHODS: Skin biopsies were taken in 17 patients in N and in PSO and/or PP. The mRNA steady-state level of angiogenesis and lymphangiogenesis markers was measured by RT-PCR. Immunohistochemistry was performed for von Willebrand factor, podoplanin, Ki-67 and VEGFR3. Blood (BV) and lymphatic (LV) vessels expansion was measured by computer-assisted morphometry. RESULTS: Clinical and epidermal aspects indicated that PP are intermediate between N and PSO. While total BV area was already increased in PP similarly to PSO as compared to N, LV area in PP was intermediate between N and PSO. Mean LV size was identical in N and PP and increased in PSO, mean BV size in PP being intermediate between N and PSO. VEGF-A 189 variant was increased in PP as compared to N and PSO. As compared to N, angiogenesis markers (VEGF-A isoforms, PlGF, VEGFR2, NRP-1), VEGF-C and NRP-2 were similarly increased in PP and PSO. Keratin 16 and the lymphangiogenesis markers (VEGFR3, prox-1) were intermediate in PP. CONCLUSION: These data suggest that the expansion of lymphatic vessels occurs after blood vascular development in psoriasis. Expansion of BV in PP could be followed by vessel enlargement during progression to PSO, in parallel with a decreased VEGF-A 189/VEGF-A 121 balance in plaques.

Assessing the Impact of Efalizumab on Nail, Scalp and Palmoplantar Psoriasis and on Quality of Life: Results from a Multicentre, Open-label, Phase IIIb/IV Trial.

This post-approval, open-label trial (n = 1266) assessed the efficacy of efalizumab, administered in accordance with the European label at that time, in patients with concomitant nail, scalp or palmoplantar psoriasis. Patients received subcutaneous efalizumab 1.0 mg/kg weekly for up to 20 weeks. By Week 12, an improvement from baseline of 50% or more was observed in 21.4% (181/844) of patients with nail psoriasis, 62.4% (718/1150) of patients with scalp psoriasis, and 51.4% (127/247) of patients with palmoplantar psoriasis. Quality of life improved throughout the trial, with a 50% median improvement in DLQI score after 12 weeks of treatment. Efalizumab showed promising efficacy in the treatment of nail, scalp and palmoplantar psoriasis, which was reflected in improvements in quality of life.

[Lymphedema and cutaneous diseases]. / Complications cutanées des lymphoedèmes.

Lymphedema is defined as an accumulation of protein-rich interstitial fluid due to failure of lymphatic drainage. Causes are divided into primary and secondary. Clinical changes of skin can occur. The major cutaneous complications are infections, dysimmune diseases and neoplasms; the most serious is angiosarcoma. The practioner should be watchful for prevention and screening of complications.

Psoriasis: severity assessment in clinical practice. Conclusions from workshop discussions and a prospective multicentre survey of psoriasis severity.

Psoriasis treatment is highly individualized. Although a standardized assessment of psoriasis severity for clinical practice may be theoretically advantageous for the purposes of determining treatment, the relevance of currently available research tools in clinical practice is uncertain. Our objectives were to ascertain in workshop discussions and through a prospective survey the relevance of standard severity measures in clinical practice with regard to choice of treatment. Although there was agreement on the possible structure of an algorithm for the treatment-related definition of psoriasis severity, consensus on the cut-off levels for the PASI and %BSA that would indicate a switch in treatment mode could not be reached. The lack of agreement prompted a prospective survey of 112 patients with psoriasis from 10 countries. This survey used a formal questionnaire asking for the PASI and %BSA scores, the patient's self assessment score (VAS ranging from 0 to 10), location of the psoriatic lesions and disease phase. Severity scores from 20 patients pre-selected for inclusion in a trial of a biological agent were included for comparison. Severity scores were analysed in relation to the choice of treatment (topical or systemic, which included phototherapy and combination) suggested by the treating physician.PASI scores differed significantly between the treatment groups (topical vs systemic, p=0.009); however, there was large overlap in the range of PASI scores between the groups. The same was true for VAS scores (topical vs systemic, p=0.035). %BSA scores were not significantly different between treatment groups. There was a large overlap for both the topical and systemic treatment groups with the biologicals group for the range of both the PASI and %BSA scores. A standardized protocol for the evaluation of psoriasis severity based on established severity scores (PASI, %BSA) appears to be unrealistic in day-to-day clinical practice. In clinical practice, a host of factors must be evaluated alongside possible metric measures. This requires experience and the specialized medical education of those involved in the treatment of patients with psoriasis.