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1.
J Eur Acad Dermatol Venereol ; 29(12): 2411-6, 2015 Dec.
Article in English | MEDLINE | ID: mdl-26370321

ABSTRACT

OBJECTIVE: Psoriasis is one of the most common forms of chronic dermatitis, affecting 2-3% of the worldwide population. It has a serious effect on the way patients perceive themselves and others, thereby prejudicing their quality of life and giving rise to a significant deterioration in their psycho-physical well-being; it also poses greater difficulties for them in leading a normal social life, including their ability to conduct a normal working life. All the above-mentioned issues imply a cost for the society. This study proposes to evaluate the impact on societal costs for the treatment of chronic plaque psoriasis with biologics (etanercept, infliximab and adalimumab) in the Italian clinical practice. METHOD: A prospective observational study has been conducted in 12 specialized centres of the Psocare network, located throughout Italy. Direct and indirect costs (as well as the health-related quality of life of patients with plaque psoriasis undergoing biologic treatments) have been estimated, while the societal impact has been determined using a cost-utility approach. RESULTS: Non-medical and indirect costs account for as much as 44.97% of the total cost prior to treatment and to 6.59% after treatment, with an overall 71.38% decrease. Adopting a societal perspective in the actual clinical practice of the Italian participating centres, the ICER of biologic therapies for treating plaque psoriasis amounted to €18634.40 per QALY gained--a value far from the €28656.30 obtained by adopting a third-party payer perspective. CONCLUSION: Our study confirms that chronic psoriasis subjects patients to a considerable burden, together with their families and caregivers, stressing how important it is to take the societal perspective into consideration during the appraisal process. Besides, using data derived from Italian actual practice, treatment with biologics shows a noteworthy benefit in social terms.


Subject(s)
Biological Products/economics , Biological Products/therapeutic use , Direct Service Costs/statistics & numerical data , Drug Costs/statistics & numerical data , Psoriasis/drug therapy , Psoriasis/economics , Adalimumab/economics , Adalimumab/therapeutic use , Adolescent , Adult , Aged , Anti-Inflammatory Agents, Non-Steroidal/economics , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Chronic Disease , Cost of Illness , Cost-Benefit Analysis , Etanercept/economics , Etanercept/therapeutic use , Female , Humans , Infliximab/economics , Infliximab/therapeutic use , Italy , Male , Middle Aged , Prospective Studies , Quality-Adjusted Life Years , Young Adult
2.
Int J Immunopathol Pharmacol ; 23(4): 1195-202, 2010.
Article in English | MEDLINE | ID: mdl-21244768

ABSTRACT

Chronic plaque psoriasis is associated to an increased risk of cardiovascular events. The aim of our study is to test patients with psoriasis for common markers of acquired and inherited thrombophilia. A cross-sectional study on 172 patients with psoriasis and 198 controls was carried out. The plasma levels of coagulation protein C, coagulation protein S, homocysteine, folic acid, C-reactive protein (CRP) and fibrinogen as well as activated protein C resistance and antithrombin III activity, were measured. CRP and homocysteine levels were higher in patients with psoriasis than in controls (5.9 ± 7.1 vs 3.1 ± 2.4 mg/L, p=0.0003 and 16.3 ± 12.8 vs 10.4 ± 4.6 umol/L, p=0.0001; mean ± SD) whereas folic acid was lower in psoriatic patients compared to controls (4.3 ± 7.2 vs 12.6 ± 7.9 p=0.006). Levels of coagulation protein C, coagulation protein S, fibrinogen as well as activated protein C resistance, antithrombin III activity were within normal ranges both in cases and controls. In a multivariate regression analysis, psoriasis severity was an independent predictor of higher CRP. In conclusion, high levels of serum CRP and homocysteine were found in patients with psoriasis, related to the severity of the disease. These data suggest that the increased risk of thrombotic cardiovascular events observed in psoriasis patients should be ascribed to an acquired rather than inherited thrombophilic status.


Subject(s)
C-Reactive Protein/analysis , Psoriasis/blood , Thrombophilia/blood , Adult , Aged , Biomarkers , Chronic Disease , Cross-Sectional Studies , Female , Folic Acid Deficiency/complications , Humans , Hyperhomocysteinemia/etiology , Male , Middle Aged , Severity of Illness Index
3.
Int J Immunopathol Pharmacol ; 22(1): 227-33, 2009.
Article in English | MEDLINE | ID: mdl-19309570

ABSTRACT

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).


Subject(s)
Antibodies, Monoclonal/therapeutic use , Psoriasis/drug therapy , Tumor Necrosis Factor-alpha/antagonists & inhibitors , Adalimumab , Adult , Aged , Antibodies, Monoclonal/adverse effects , Antibodies, Monoclonal, Humanized , Dose-Response Relationship, Drug , Female , Humans , Male , Middle Aged
4.
J Biol Regul Homeost Agents ; 22(4): 233-7, 2008.
Article in English | MEDLINE | ID: mdl-19036225

ABSTRACT

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.


Subject(s)
Antibodies, Monoclonal/therapeutic use , Psoriasis/therapy , Adalimumab , Adult , Aged , Antibodies, Monoclonal, Humanized , Arthritis, Psoriatic/complications , Arthritis, Psoriatic/pathology , Arthritis, Psoriatic/therapy , Biological Products/therapeutic use , Body Mass Index , Female , Humans , Hypertension/complications , Male , Middle Aged , Psoriasis/complications , Psoriasis/pathology , Treatment Outcome , Tumor Necrosis Factor-alpha/antagonists & inhibitors , Young Adult
5.
G Ital Dermatol Venereol ; 143(5): 329-37, 2008 Oct.
Article in English | MEDLINE | ID: mdl-18833074

ABSTRACT

RESULTS: For over five years, we have been using a new ultraviolet B ray source, a Xenon-Chloride lamp emitting non-coherent, monochromatic 308-nm light that represents the natural evolution of the excimer laser. A source of monochromatic excimer light (MEL) produces 50 mW/cm(2) power density at a distance of 15 cm from the source and has a maximum irradiating area of 504 cm(2), this feature representing the greatest therapeutic advantage offered by 308 nm sources. On the other hand, the benefits offered by the MEL compared to traditional phototherapies are essentially correlated to the fact that there is no need to administer oral psoralens (PUVA therapy) and that sessions need to be repeated only every 7-15 days, an important condition for the improvement of the patient's quality of life (since at least 2-3 weekly sessions are required with the traditional UVB therapy). Using MEL, UV B light can be applied on the entire body, with partial subintrant skin irradiations, or on one or just a few individual patches, taking care to accurately protect the healthy surrounding skin and allowing for a phototherapy exclusively targeted onto the lesion to be treated. Clinical indications and the reasons for choosing MEL for the treatment of photosensitive skin disorders are virtually identical to those stated for PUVA therapy or narrowband UV B light. Due to the absence of photosensitizing substances and drug-induced toxicity, patients who work in the open air, pregnant women and patients suffering from liver or kidney failure can also be treated. Furthermore, the short time required for sessions, the duration of cycles and the selective exposure of the skin areas to be treated undoubtedly represent significant benefits for patients in terms of safety and efficacy. In addition to psoriasis, the use of MEL can also be extended to other pathologies such as vitiligo, alopecia areata, atopic dermatitis and patch-stage IA mycosis fungoides with encouraging


Subject(s)
Lasers, Excimer/therapeutic use , Skin Diseases/radiotherapy , Humans
6.
Int J Immunopathol Pharmacol ; 20(3): 647-50, 2007.
Article in English | MEDLINE | ID: mdl-17880779

ABSTRACT

Infliximab is an anti-tumour necrosis factor-alpha chimeric monoclonal antibody which is highly effective in psoriasis, as well as in other indications. In clinical practice, some patients may require dose escalation to overcome a reduction of the extent and/or duration of response during regular maintenance treatment, possibly due to the loss of stable serum concentrations of the drug. Common strategies of dose escalation are the increase of dose per infusion and the decrease of interval between infusions. Here we report the results of re-induction therapy with infliximab used as a dose escalation strategy in 9 patients whose psoriasis relapsed during maintenance treatment with infliximab 5 mg/kg every 8 weeks. Re-induction was well tolerated and capable of restoring response in 8 of these patients.


Subject(s)
Antibodies, Monoclonal , Dermatologic Agents , Psoriasis/drug therapy , Adult , Antibodies, Monoclonal/administration & dosage , Antibodies, Monoclonal/therapeutic use , Dermatologic Agents/administration & dosage , Dermatologic Agents/therapeutic use , Dose-Response Relationship, Drug , Drug Administration Schedule , Female , Humans , Infliximab , Infusions, Intravenous , Male , Middle Aged , Prospective Studies , Psoriasis/prevention & control , Remission Induction , Secondary Prevention , Treatment Outcome
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