Search

Introduction : Psoriasis is a chronic inflammatory systemic disease that affects 2% of the population and is associated with an important physical and physiological burden. About 0.5-2% of psoriatic cases onset during the pediatric age range, and often it's not diagnosed until adulthood. Adalimumab is an antitumor necrosis factor monoclonal antibody approved for use in children in 2008 and now it was used in several diseases in rheumatology, gastroenterology, and in dermatology. Areas covered : The purpose of this article was to summarize what has been described in the literature so far, about safety in the use of adalimumab in pediatric psoriasis. The presented data was extrapolated from a literature review from PubMed searches (using words 'pediatric psoriasis,' 'adalimumab children,' 'adalimumab safety,' 'pediatric psoriasis treatment,' 'adalimumab clinical trial'), treatment guidelines, and reports from European and United States regulatory agencies. Expert opinion : Actually there are some biologic agents for the treatment of pediatric psoriasis, but the lack of safety data from controlled trials is evident. The safety data on the use of adalimumab in pediatric psoriasis was taken from long-term studies in the adult population. These studies confirm the data on the safety of the drug as it is also supported by several works on real-life.

Introduction: During treatment with biologic agents for psoriasis (Pso) in a number of patients a failure may occur and discontinuation with transitioning to another drug or an optimization strategy, consisting in a dose-adjustment or a co-medication with a traditional systemic agent, represent two possible alternatives. Objective: The SAFARI study objective was a retrospective observation of adalimumab efficacy and safety profile after switching from other anti-TNFα agents related to clinician behavior after the failure of the first-line agent. Results: The retrospective multicenter observation demonstrated that after a first-line anti-TNFα failure adalimumab efficacy was consistent at week-12 and 24 with a further significant improvement at week-48 with a proportion of patients achieving PASI75/PASI90/PASI100 of 83.3, 71.6, and 56.9.%, respectively. Clinician strategies to extend drug-survival after first-line anti-TNFα failure, such as co-medication or dose-adjustment, were irrelevant to future drug effectiveness. Conclusions: Adalimumab profile was excellent in this 5-year retrospective observation, showing the clinical validity of interclass transitioning among anti-TNFα options.

Background: This retrospective study aimed to evaluate the long-term efficacy and effects on lipid profile and Atherogenic Index of antitumor necrosis factor (TNF)α therapy with adalimumab in patients with moderate-to-severe psoriasis or psoriatic arthritis., Methods: Sixty-nine psoriatic patients treated with adalimumab 40 mg every other week were included. Patients were treated continuously for four years; study visits took place every 24 weeks. Disease severity (Psoriasis Area Severity Index [PASI], Nail Psoriasis Severity Index [NAPSI], articular pain intensity), disease burden (PSOdisk), serum lipid concentrations, Atherogenic Index, and inflammatory markers were assessed at each visit., Results: Disease severity improved significantly during treatment. After 24 weeks, 89.9% of patients achieved a PAS I75 response; 79.7% and 46.4% had PASI 90 and PASI 100 responses, respectively. Response was sustained over four years. NAPSI Score, articular pain and disease burden improved significantly. Lipid serum concentrations and inflammatory markers were overall stable and within the range of normality. High-density lipoprotein cholesterol concentrations increased significantly and Atherogenic Index improved. The four years of uninterrupted treatment with adalimumab was well tolerated., Conclusions: Long-term treatment of moderate-to-severe psoriatic disease with adalimumab is effective, well tolerated, and potentially beneficial also in terms of lipid pattern and atherogenic risk.

Background: The genetic basis of predisposition to psoriasis is recognised; however, the response to psoriasis treatment in patients with different genetic predisposition is poorly understood., Objective: To analyse the presence of the HLA-C*06:02 polymorphism in psoriatic patients treated with adalimumab., Methods: Genomic DNA was extracted from whole blood of 122 patients with moderate-to-severe psoriasis treated with adalimumab for 3 years. Genotyping was performed using PCR. Disease severity was assessed by the Psoriasis Area and Severity Index (PASI) at day 0 and after 1, 3, 6, 12, 24 and 36 months. Logistic regression was used to evaluate the association between dependent variables (including HLA-C*06:02 status) and achievement of PASI 50, 75 and 90., Results: No difference was observed after adalimumab treatment between C*06:02 positive (HLA-C*06:02-POS) patients (n = 46) and C*06:02 negative (HLA-C*06:02-NEG) patients (n = 76) over the 3-year follow-up period in terms of PASI response or time-course when PASI response was achieved. However, a small, but non-statistically significant difference was noted between genotypes for PASI 50 at 1 month (HLA-C*06:02-NEG: 44.7% vs. HLA-C*06:02-POS: 56.5%) and at 3 months (HLA-C*06:02-NEG: 71.1% vs. HLA-C*06:02-POS: 80.4%). Simple logistic regression analysis did not reveal an association between independent variables (including C*06:02 status) and PASI response; however, multivariate regression revealed that gender (females better than males) was associated with achievement of PASI 50 at month 1 (OR 0.34, 95% CI 0.16-0.72, p = 0.005) and of PASI 75 at 3 months (OR 0.36, 95% CI 0.16-0.8, p = 0.012)., Conclusion: Adalimumab reduced long-term severity in patients with moderate-severe psoriasis, independent of their HLA-C*06:02 status.

Background: 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., Objectives: To evaluate long-term clinical outcomes of the anti-TNF-α monoclonal antibody, adalimumab, in patients with psoriasis (PsO) or psoriatic arthritis (PsA) referring to an Italian dermatological centre., Methods: Single-centre retrospective real-world investigation with an observation period of up to 9 years., Results: We reviewed the records of 316 patients (117 with PsO and 199 with PsA) treated with adalimumab and followed for up to 9 years. Safety and efficacy of adalimumab were consistent with those described in randomised controlled trials (RCTs) and other observational studies. A rapid and sustained improvement of skin lesions (evaluated as Psoriasis Area and Severity Index (PASI) 75, PASI 90 and PASI 100 response rates) was observed in the majority of patients, including those with body mass index (BMI) >30 and with prior experience of biologic therapies (including other anti-TNFs). The safety profile of adalimumab was confirmed also in elderly patients (>65 years)., Conclusion: Our real-life experience shows that the long-term treatment with adalimumab is effective and well tolerated in psoriatic patients, including overweight/obese, elderly and anti-TNF-experienced subjects., (© 2016 European Academy of Dermatology and Venereology.)

Background: Psoriasis is a chronic skin disorder which negatively impacts a patient's quality of life (QoL). A recently published assessment tool, PsoDisk, has been proposed to evaluate patient's QoL., Objective: The aim of this study was to test PsoDisk as a QoL assessment tool in psoriatic patients undergoing treatment with adalimumab., Methods: A 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., Results: In 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., Conclusion: PsoDisk was found to be easy to administer and intuitive for interpreting clinical results.

ABP 501 is a biosimilar to the anti-tumor necrosis factor-alfa monoclonal antibody adalimumab and despite its effectiveness and safety in the treatment of psoriasis was demonstrated in randomized clinical trials, no real-life data are available, in particular in patients undergoing non-medical switch from originator to biosimilar. We retrospectively searched our clinical records for all patients receiving ABP 501 between March 10, 2019 and September 7, 2019 at our Department. Therefore, we identified 94 patients, 46 patients underwent non-medical switch from adalimumab reference product to ABP 501. In originator-naïve patients, mean PASI significantly improved from baseline to week 24 (p <.0001) in both Pso and PsA cohorts. In these patients, mean DAS-28 ESR improved with no significant differences from baseline. In patients undergoing non-medical switch from adalimumab reference product to ABP 501, no significant difference in PASI or DAS-28 ESR were observed from week 16 before switch to week 24 after switch. AB- 501 is an effective treatment for plaque-type psoriasis and psoriatic arthritis regardless if patients are originator-naïve or if they were switched from the reference product. [ABSTRACT FROM AUTHOR]

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 [ABSTRACT FROM AUTHOR]