Arianna Zangrilli

Efficacy and Safety of Subcutaneous Anti-Tumor Necrosis Factor-Alpha Agents, Etanercept and Adalimumab, in Elderly Patients Affected by Psoriasis and Psoriatic Arthritis: An Observational Long-Term Study

Background: In elderly patients the management of psoriasis is challenging due to contraindications and a higher risk of side effects. Objective: Our retrospective study aimed to evaluate the long-term efficacy and safety profile of subcutaneous anti-tumor necrosis factor (anti-TNF) agents in elderly psoriatic patients. Methods: The study included 89 patients (aged ≥65 years) with plaque-type psoriasis and psoriatic arthritis treated with the subcutaneous anti-TNF-α agents etanercept or adalimumab as monotherapy for a long-term continuous period. Results: Efficacy results were consistent and stable over long-term observation, as expressed by mean Psoriasis Area and Severity Index (PASI) score variation, percentage of patients achieving PASI50 and PASI75 and by the improvement of articular indices, pain visual analogue scale (Pain-VAS) and 44-Joint Disease Activity Score (DAS44-ESR). The proportion of patients achieving PASI50 was 91.80 and 82.14% at week 156 with etanercept and adalimumab treatment, respectively, while the proportion of patients achieving PASI75 was 83.61 and 71.43% at week 156 when treated with etanercept and adalimumab, respectively. The mean DAS44-ESR score decreased from 5.80 to 0.89 and from 3.43 to 1.44 at week 156 and the mean Pain-VAS score decreased from 75.10 to 3.15 and from 71.30 to 18.26 at week 156 with etanercept and adalimumab treatment, respectively. Both treatment adherence and safety profile were good. Conclusions: Our study demonstrates that subcutaneous anti-TNF-α agents are appropriate in the long-term management of elderly patients.

Long‐term efficacy of adalimumab in generalized pustular psoriasis

Background: Generalized pustular psoriasis (GPP) is a rare form of psoriasis that may either be preceded by plaque psoriasis or arise de novo, classically after withdrawal of systemic glucocorticosteroids. Adalimumab is a fully human, anti‐TNF‐α monoclonal antibody that specifically blocks the interaction of TNF‐α with the p55 and the p75 TNF‐α cell surface receptors. Aim: To demonstrate the efficacy and tolerability of adalimumab in the treatment of GPP. Case report: A 50‐year‐old woman had suffered from severe pustular psoriasis for 10 years and psoriatic arthritis for 8 years and received treatment with adalimumab, in monotherapy, 40 mg subcutaneously once a week for 72 weeks. DLQI, PDI and SKINDEX 29 score were used to assess patient compliance and satisfaction. Results: In our case, control of disease manifestations was rapid and clinical remission persisted during the treatment course until the 72th week. Treatment tolerability and compliance were consistent. The patient experienced a dramatic improvement of quality of life instruments. Conclusion: In this case, adalimumab has been demonstrated to be effective, safe and appropriate for long‐term use, indicating a beneficial effect on quality of life parameters.

Long‐term efficacy of etanercept in hidradenitis suppurativa

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TNF-α antagonists and nail psoriasis: an open, 24-week, prospective cohort study in adult patients with psoriasis.

Introduction: Treatment of nail psoriasis can be challenging and unsatisfactory. The aim of this study was to compare the efficacy of three different anti-TNF-α agents on nail psoriasis in patients affected by psoriasis. Materials and methods: Seventy-two patients with nail psoriasis were evaluated in this open, 24 weeks, prospective study. Patients were enrolled in three groups of treatment: adalimumab, etanercept or infliximab. Severity of nail psoriasis was assessed by the Nail Psoriasis Severity Index (NAPSI) at baseline, week 14, and 24. Results: Sixty patients were included in the study. The mean NAPSI was 33.77. In the adalimumab group, the mean NAPSI score was 33.1 (± 14.9) at baseline, 21 (± 8.91) at week 14 and 11.4 (± 4.6) at week 24 (p < 0.0002). In the etanercept group, the mean NAPSI was 34.8 (± 12.38) at baseline, 23.6 (± 10.43) at week 14, and 10.6 (± 5.25) at week 24 (p < 0.0016). In the infliximab group, the mean NAPSI was 33.3 (± 9.76) at baseline, 14.9 (± 4.20) at week 14 (p < 0.001) and 3.1 (± 3.27) at week 24 (p < 0.00001). At week 14 efficacy was higher in infliximab group compared to adalimumab and etanercept groups (p < 0.05). Conclusions: Among the three agents, in the infliximab group a significant improvement in nail psoriasis was observed as early as week 14 of therapy whereas in the adalimumab and etanercept groups at week 24.

Bullous dermatomyositis: A marker of poor prognosis and aggressive internal malignancy?

infected lesiotis and the persistence of HPV seems to be related to this reduction or to LC altered function (14). In a recent review ( I ) it was des^cribed that HPV does not infect or replicates in APCs located in the epithelium, resulting in failure ofHPV presentation to the immune system. Another possibility is that LCs. although able to bind and internalize HPV. are not activated by these events and they do not induce a response. This indicates that LC may be a target used by HPV as an immune escape mechanism (15). The increased number of hypertrophie FXIIla-tDD in HPV vulvar lesions suggests that this group of cells might play a role in the pathogenesis of HPV infection. Considering that FXlIIa+ DD are capable of antigen presenting, the present study leads tis to suggest that FXllla-i DDwouldbcable to engulf the viral antigens and to promote their presentation to the immune system.

Evaluation of Clinical and Ultrasonographic Parameters in Psoriatic Arthritis Patients Treated with Adalimumab: A Retrospective Study

Objectives. The aim of this study was to evaluate clinical and US-PD parameters in PsA during adalimumab treatment. Methods. A retrospective study has been conducted in forty patients affected by moderate-to-severe peripheral PsA. Clinical, laboratory, and US-PD evaluations were performed at baseline, after 4, 12, and 24 weeks of treatment. They included erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), visual analogue scale (VAS), Health Assessment Questionnaire (HAQ) modified for Spondyloarthritis, Psoriasis Area Severity Index (PASI) score, the 28-joint Disease Activity Score (DAS 28), and US-PD assessment. US-PD findings were scored according to a semiquantitative scale (ranging 0–3) for synovial proliferation (SP), joint effusion (SE), bone erosions (BE), and PD. Results. Data obtained for clinical, laboratory findings and US-PD evaluation showed statistical significant improvement in all the measures performed except for BE. A significant parallel decrease in SE, SP, and PD values were demonstrated. Conclusion. This study demonstrated that US-PD is a valid technique in monitoring the response to adalimumab in moderate-to-severe PsA.

Adalimumab in the treatment of plaque-type psoriasis and psoriatic arthritis

Introduction: Psoriasis and psoriatic arthritis (PsA) are chronic immune-mediated diseases, and TNF-α (tumor necrosis factor) is a pro-inflammatory cytokine that plays a critical role in the pathogenesis of these conditions. Adalimumab is an anti-TNF-α drug widely used for the treatment of both psoriasis and PsA. Controlled clinical trials demonstrated that adalimumab is characterized by a high degree of clinical response. The aim of this review is to report the safety, efficacy, and recent findings in the treatment of psoriasis and PsA with adalimumab. Areas covered: This article reviews the results of Phase II, III, controlled, and observational clinical studies on adalimumab in the treatment of psoriasis and PsA. A systematic search was conducted using the Pubmed Medline database for primary articles. Expert opinion: Treatment of psoriasis and PsA represents a therapeutic challenge for dermatologists and rheumatologists. The efficacy, tolerability, and safety profiles suggest adalimumab as a suitable anti-psoriatic drug in the long-term treatment of psoriasis and PsA. Management of long-term treatment, loss of efficacy, and comorbidities has been described.

Real-life 9-year experience with adalimumab in psoriasis and psoriatic arthritis: results of a single-centre, retrospective study.

Observational studies in daily practice are an essential complement to pivotal randomised controlled trials because their findings refer to larger and more diverse patient populations with common comorbidities, complex medical history, concomitant medications and longer follow‐up periods.

Quality of life of psoriatic patients evaluated by a new psychometric assessment tool: PsoDisk

BackgroundPsoriasis is a chronic skin disorder which negatively impacts a patient’s quality of life (QoL).Arecently published assessment tool, PsoDisk, has been proposed to evaluate patient’s QoL.ObjectiveThe aim of this study was to test PsoDisk as a QoL assessment tool in psoriatic patients undergoing treatment with adalimumab.MethodsA retrospective, monocentric study, including patients who completed at least 48 weeks of both adalimumab therapy and PsoDisk assessment. PASI was assessed by the physician whereas the PsoDisk test was self-performed by the patient. Both were evaluated at each control visit throughout the study-period in order to detect changes in disease severity and the impact of quality of life, respectively.ResultsIn total, we evaluated 31 patients selected from our database. At baseline, all aspects of patients’ psycho-emotional and social lives were impaired. PASI score reduction correlated with a PsoDisk score decrease (r = 0.97; p = 0.02), reflecting an overall improvement of patient’s QoL.ConclusionPsoDisk was found to be easy to administer and intuitive for interpreting clinical results.

Detection of Adalimumab and Anti-Adalimumab Levels by ELISA: Clinical Considerations

Enabling Technology, Genomics, Proteomics Clinical Development Phases I‐III Regulatory, Quality, Manufacturing