Metabolic abnormalities associated with initiation of systemic treatment for psoriasis: evidence from the Italian Psocare Registry.

Objective To evaluate variations in laboratory parameters and diagnoses of selected clinical conditions up to16 weeks after starting a new systemic psoriasis treatment for Psocare Registry enrollees.Design Prospective cohort study.Setting Italian public referral centres for psoriasis treatment.Patients First-time recipients (n = 10,539) of continuous systemic psoriasis treatment for at least 16 weeks.Main outcome measure Mean variations in (weeks 8 and 16) and proportions of patients reaching a clinicallymeaningful increase in serum levels (week 16) of total and low-density lipoprotein cholesterol, triglycerides, aspartateamino transferase, alanine amino transferase and creatinine, as well as week-16 cumulative incidences of newdiagnoses of diabetes mellitus and arterial hypertension.Results Mean cholesterol and triglyceride levels significantly increased in patients treated with acitretin orcyclosporine. Mean triglyceride levels also increased in efalizumab- and etanercept-treated patients. Meantransaminase values increased in methotrexate-treated patients, and mean aspartate amino transferase levelsincreased in infliximab-treated patients. The average serum creatinine value increased in cyclosporine-treatedpatients. Acitretin and cyclosporine were associated with risk of hypercholesterolaemia (odds ratios 1.51 and 1.34)and acitretin with risk of hypertriglyceridaemia (odds ratio 1.43). Methotrexate and infliximab were associated withrisk of more than doubling the upper normal aspartate amino transferase (odds ratios 2.06 and 1.87) and alanineamino transferase (odds ratios 2.38 and 1.74) values. The relative risk of developing arterial hypertension anddiabetes was increased for patients receiving cyclosporine (odds ratios 3.31 and 2.88).Conclusion Systemic treatments for psoriasis resulted in heterogeneous effects on the parameters analysed.Received: 1 September 2011; Accepted: 12 January 201

Cardiopoietic cell therapy for advanced ischemic heart failure: results at 39 weeks of the prospective, randomized, double blind, sham-controlled CHART-1 clinical trial

Cardiopoietic cells, produced through cardiogenic conditioning of patients' mesenchymal stem cells, have shown preliminary efficacy. The Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial aimed to validate cardiopoiesis-based biotherapy in a larger heart failure cohort

Metabolic abnormalities associated with initiation of systemic treatment for psoriasis:evidence from the Italian Psocare Registry

OBJECTIVE: To evaluate variations in laboratory parameters and diagnoses of selected clinical conditions up to 16 weeks after starting a new systemic psoriasis treatment for Psocare Registry enrollees. DESIGN: Prospective cohort study. SETTING: Italian public referral centres for psoriasis treatment. PATIENTS: First-time recipients (n = 10,539) of continuous systemic psoriasis treatment for at least 16 weeks. MAIN OUTCOME MEASURE: Mean variations in (weeks 8 and 16) and proportions of patients reaching a clinically meaningful increase in serum levels (week 16) of total and low-density lipoprotein cholesterol, triglycerides, aspartate amino transferase, alanine amino transferase and creatinine, as well as week-16 cumulative incidences of new diagnoses of diabetes mellitus and arterial hypertension. RESULTS: Mean cholesterol and triglyceride levels significantly increased in patients treated with acitretin or cyclosporine. Mean triglyceride levels also increased in efalizumab- and etanercept-treated patients. Mean transaminase values increased in methotrexate-treated patients, and mean aspartate amino transferase levels increased in infliximab-treated patients. The average serum creatinine value increased in cyclosporine-treated patients. Acitretin and cyclosporine were associated with risk of hypercholesterolaemia (odds ratios 1.51 and 1.34) and acitretin with risk of hypertriglyceridaemia (odds ratio 1.43). Methotrexate and infliximab were associated with risk of more than doubling the upper normal aspartate amino transferase (odds ratios 2.06 and 1.87) and alanine amino transferase (odds ratios 2.38 and 1.74) values. The relative risk of developing arterial hypertension and diabetes was increased for patients receiving cyclosporine (odds ratios 3.31 and 2.88). CONCLUSION: Systemic treatments for psoriasis resulted in heterogeneous effects on the parameters analysed

Comparison of two etanercept regimens for treatment of psoriasis and psoriatic arthritis: Presta randomized double blind multicentre trial

Objectives To compare the efficacy over 12 weeks of two different etanercept regimens in treating the skin manifestations of psoriasis in patients who also have psoriatic arthritis and to evaluate efficacy and safety over an additional 12 weeks of open label etanercept treatment. Design Randomised double blind multicentre outpatient study. Setting 98 outpatient facilities in Europe, Latin America, and the Asia Pacific region. Participants 752 patients with both psoriasis (evaluated by dermatologists) and psoriatic arthritis (evaluated by rheumatologists). Interventions During the blinded portion of the study, participants were randomised to receive etanercept 50 mg twice weekly (n=379) or 50 mg once weekly (n=373) for 12 weeks by subcutaneous injection. All participants then received open label etanercept 50 mg once weekly for 12 additional weeks, while remaining blinded to the regimen. Main outcome measures The primary efficacy end point was the proportion of participants achieving “clear” or “almost clear” on the physician’s global assessment of psoriasis at week 12. Secondary efficacy analyses included psoriasis area and severity index, American College of Rheumatology responses, psoriatic arthritis response criteria, and improvement in joint and tendon disease manifestations. Results At week 12, 46% (176/379) of participants receiving etanercept 50 mg twice weekly achieved a physician’s global assessment of psoriasis of “clear” or “almost clear” compared with 32% (119/373) in the group treated with 50 mg once weekly (P<0.001). In contrast, an equally high percentage of participants in both groups achieved psoriatic arthritis response criteria (77% (284/ 371) in the twice weekly/once weekly group versus 76% (282/371) in the once weekly/once weekly group). Participants treated with 50 mg twice weekly/once weekly had greater mean reductions from baseline in the psoriasis area and severity index at week 12 compared with those who received 50 mg once weekly/once weekly(71% v 62%, P<0.001), with less difference at week 24 (78% v 74%, P<0.110). Joint and tendon disease manifestations improved from baseline in both groups to a similar extent. No new safety signals were seen in either etanercept treatment group, and no significant difference in the safety profiles was observed. Conclusions In participants with active psoriasis and psoriatic arthritis, initial treatment of the psoriasis with etanercept 50 mg twice weekly may allow for more rapid clearance of skin lesions than with 50 mg once weekly. A regimen of 50mgonce weekly seems to be appropriate for treatment of joint and tendon rheumatic symptoms. The choice of regimen should be determined by the clinical needs of the individual patient

Psycological distress and coping strategies in patients with psoriasis: the PSYCHAE study

Objective Our objectives were to determine the prevalence of psychological distress in a large sample of Italian patients with psoriasis; to establish whether disease severity and psychological distress are associated; to identify the strategies employed to cope with psoriasis; to evaluate the coping strategies employed by dermatologists; and to identify potential predictors of psychological distress. Design Cross-sectional. Setting Thirty-nine Italian dermatology centres. Subjects One thousand five hundred and eighty (1580) patients with psoriasis. Methods Minor psychological distress was evaluated using the General Health Questionnaire-12 (GHQ-12) and major psychopathological distress using the Brief Symptom Inventory (BSI); coping strategies were evaluated using the Brief COPE questionnaire; disease severity was evaluated using the body surface area index. Results Patients were aged 44 ± 13 years (mean ± SD) and were mainly men (57%). Minor psychological distress was present in 46% of patients and major psychopathological distress in 11% of them. Both minor (54% vs. 40%, P < 0.0001) and major (17% vs. 7%, P < 0.0001) distress were more frequent in women than in men. The psychological status of women was worse than that of men independently from the extension of psoriasis. There was no association between the presence of distress and the treatment prescribed by dermatologists. Planning and active coping were the strategies most commonly employed by patients to cope with psoriasis, but there were between-gender differences. Most dermatologists employed a ‘problem-orientated’ attitude in caring for patients. Conclusions (i) Psychological distress was relatively frequent in our patients with psoriasis; (ii) female gender was the most important predictive factor for psychological distress; (iii) there was no association between psoriasis severity and psychological distress; (iv) planning and active coping were the coping strategies most frequently employed by patients; and (v) most dermatologists employed a problem-orientated attitude in caring for patients

Impact of Body Mass Index and Obesity on Clinical Response to Systemic Treatment for Psoriasis

Objective: Our aim was to assess the role of the body mass index (BMI) in the clinical response to systemic treatment for psoriasis. Methods: A nationwide cohort study of patients receiving a new systemic treatment for plaque psoriasis at reference centres in Italy was conducted. Information was gathered through a web-based electronic form. Patients being maintained on the same medication and with data available at 8 and 16 weeks by March 31, 2007, were eligible. The outcome was a reduction in the Psoriasis Area Severity Index ( PASI) of at least 75% at follow-up compared to baseline (PASI-75). Results: Out of 8,072 patients enrolled, 2,368 were eligible and analysable at 8 weeks and 2,042 at 16 weeks. PASI-75 was achieved by 819 patients (34.5%) at 8 weeks and 1,034 (50.6%) at 16 weeks. The proportion steadily decreased with increased values of BMI. Compared to normal weight ( BMI = 20-24) the adjusted odds ratio for achieving PASI-75 in obese patients was 0.73 ( 95% Cl = 0.58-0.93) at 8 weeks and 0.62 ( 95% Cl = 0.49-0.79) at 16 weeks. The impact of the BMI did not show remarkable variations according to the drug prescribed at entry. Conclusion: The BMI affects the early clinical response to systemic treatment for psoriasis. Copyright (c) 2008 S. Karger AG, Base

Impact of body mass index and obesity on clinical response to systemic treatment for psoriasis

Objective: Our aim was to assess the role of the body mass index (BMI) in the clinical response to systemic treatment for psoriasis. Methods: A nationwide cohort study of patients receiving a new systemic treatment for plaque psoriasis at reference centres in Italy was conducted. Information was gathered through a web-based electronic form. Patients being maintained on the same medication and with data available at 8 and 16 weeks by March 31, 2007, were eligible. The outcome was a reduction in the Psoriasis Area Severity Index (PASI) of at least 75% at follow-up compared to baseline (PASI-75). Results: Out of 8,072 patients enrolled, 2,368 were eligible and analysable at 8 weeks and 2,042 at 16 weeks. PASI-75 was achieved by 819 patients (34.5%) at 8 weeks and 1,034 (50.6%) at 16 weeks. The proportion steadily decreased with increased values of BMI. Compared to normal weight (BMI = 20\u201324) the adjusted odds ratio for achieving PASI-75 in obese patients was 0.73 (95% CI = 0.58\u20130.93) at 8 weeks and 0.62 (95% CI = 0.49\u20130.79) at 16 weeks. The impact of the BMI did not show remarkable variations according to the drug prescribed at entry. Conclusion: The BMI affects the early clinical response to systemic treatment for psoriasis

Impatto dell'indice di massa corporea e dell'obesità sulla risposta clinica al trattamento sitemico per la psoriasi

Obiettivo: lo scopo del presente studio era valutare il ruolo dell'indice di massa corporea (Body Mass Index, BMI) nella risposta clinica al trattamento sistemico per la psoriasi. Metodi: è stato condotto uno studio di coorte a livello nazionale su pazienti sottoposti ad un nuovo trattamento sistemico per la psoriasi a placche presso centri di riferimento italiani. Le informazioni sono state raccolte con l'ausilio di una scheda-web. Sono stati considerati eleggibili per lo studio i pazienti trattati con lo stesso farmaco e i cui dati erano disponibili a 8 e 16 settimane di follow-up completato entro il 31 marzo 2007. l'outcome era rappresentato da una riduzione di almeno il 75% dell'indice PASI (psoriasi area severity index) al follow-up rispetto al basale (PASI-75). Risultati: degli 8072 pazienti arruolati, 2368 soggetti erano eleggibili a sono stati analizzati a 8 settimane e 2042 a 16 settimane. Il PASI-75 è stato raggiunto da 819 (34,5%) pazienti a 8 settimane e da 1034 (50,6%) pazienti a 16 settimane. la percentuale dimiglioramento diminuiva stabilmente all'aumentare dei valori di BMI. Rispetto ai soggetti di peso normale (BMI 20-24), l'odds ratio corretto per il raggiungimento del PASI-75 nei pazienti obesi era 0,73 (IC al 95%=0,58-0,93) a 8 settimane e 0,62 (IC al 95%=0,49-0,79) a 16 settimane. L'impatto del BMI non ha mostrato variazione di rilievo a seconda del farmaco prescritto all'ingresso. Conclusioni: il BMI influenza la risposta clinica precoce al trattamento sistemico per la psoriasi

Cervical musculoskeletal impairments in the 4 phases of the migraine cycle in episodic migraine patients

ObjectiveTo assess cervical musculoskeletal impairments during the 4 phases of a migraine cycle in episodic migraine patients, controlling for the presence of concomitant neck pain.MethodsDifferences in cervical musculoskeletal impairments were assessed during the 4 migraine phases in episodic migraine patients and compared with healthy controls controlling for concomitant neck pain. Cervical musculoskeletal impairments were assessed as follow: cervical active range of motion; flexion rotation test; craniocervical flexion test and calculation of activation pressure score; the total number of myofascial trigger points in head/neck muscles; the number of positivevertebral segments (headache’s reproduction) during passive accessory intervertebral movement; pressure pain thresholds over C1, C2, C4, C6 vertebral segments bilaterally, trigeminal area, hand, and leg. Signs of pain sensitization were assessed by evaluating mechanical pain threshold over trigeminal area and hand, pressure pain thresholds, and the wind-up ratio. The Bonferroni-corrected p-value (05/4 = 0.013) was adopted to assess the difference between groups, while a p-value of 0.05 was considered significant for the correlation analysis.ResultsA total of 159 patients and 52 controls were included. Flexion rotation test and craniocervical flexion test were reduced in all 4 phases of the migraine cycle versus healthy controls (p &lt; 0.001). The number of myofascial trigger points and positive vertebral segments was increased in all 4 phases of the migraine cycle versus healthy controls (p &lt; 0.001). Flexion, extension, and total cervical active range of motion and cervical pressure pain thresholds were reduced in episodic migraine in the ictal phase versus controls (p &lt; 0.007) with no other significant differences. Outside the ictal phase, the total cervical active range of motion was positively correlated with trigeminal and leg pressure pain threshold (p &lt; 0.026), the number of active myofascial trigger points and positive positive vertebral segments were positively correlated with higher headache frequency (p=0.045), longer headache duration (p &lt; 0.008), and with headache-related disability (p = 0.031). Cervical pressure pain thresholds were positively correlated with trigeminal, hand, and leg pressure pain threshold (p &lt; 0.001), and trigeminal and leg mechanical pain thresholds (p &lt; 0.005), and negatively correlated with the wind-up ratio (p &lt; 0.004).ConclusionIn all phases of the migraine cycle, independent of the presence of concomitant neck pain, episodic migraine patients showed reduced flexion rotation test and craniocervical flexion test and an increased number of myofascial trigger points and passive accessory vertebral segments. These impairments are correlated with enhanced headache duration, headache-related disability, and signs of widespread pain sensitization. Reduction in active cervical movement and increased mechanical hyperalgesia of the cervical was consistent in ictal episodic migraine patients and the subgroups of episodic migraine patients with more pronounced widespread sensitization

Cervical musculoskeletal impairments in the 4 phases of the migraine cycle in episodic migraine patients

ObjectiveTo assess cervical musculoskeletal impairments during the 4 phases of a migraine cycle in episodic migraine patients, controlling for the presence of concomitant neck pain.MethodsDifferences in cervical musculoskeletal impairments were assessed during the 4 migraine phases in episodic migraine patients and compared with healthy controls controlling for concomitant neck pain. Cervical musculoskeletal impairments were assessed as follow: cervical active range of motion; flexion rotation test; craniocervical flexion test and calculation of activation pressure score; the total number of myofascial trigger points in head/neck muscles; the number of positivevertebral segments (headache’s reproduction) during passive accessory intervertebral movement; pressure pain thresholds over C1, C2, C4, C6 vertebral segments bilaterally, trigeminal area, hand, and leg. Signs of pain sensitization were assessed by evaluating mechanical pain threshold over trigeminal area and hand, pressure pain thresholds, and the wind-up ratio. The Bonferroni-corrected p-value (05/4 = 0.013) was adopted to assess the difference between groups, while a p-value of 0.05 was considered significant for the correlation analysis.ResultsA total of 159 patients and 52 controls were included. Flexion rotation test and craniocervical flexion test were reduced in all 4 phases of the migraine cycle versus healthy controls (p &lt; 0.001). The number of myofascial trigger points and positive vertebral segments was increased in all 4 phases of the migraine cycle versus healthy controls (p &lt; 0.001). Flexion, extension, and total cervical active range of motion and cervical pressure pain thresholds were reduced in episodic migraine in the ictal phase versus controls (p &lt; 0.007) with no other significant differences. Outside the ictal phase, the total cervical active range of motion was positively correlated with trigeminal and leg pressure pain threshold (p &lt; 0.026), the number of active myofascial trigger points and positive positive vertebral segments were positively correlated with higher headache frequency (p=0.045), longer headache duration (p &lt; 0.008), and with headache-related disability (p = 0.031). Cervical pressure pain thresholds were positively correlated with trigeminal, hand, and leg pressure pain threshold (p &lt; 0.001), and trigeminal and leg mechanical pain thresholds (p &lt; 0.005), and negatively correlated with the wind-up ratio (p &lt; 0.004).ConclusionIn all phases of the migraine cycle, independent of the presence of concomitant neck pain, episodic migraine patients showed reduced flexion rotation test and craniocervical flexion test and an increased number of myofascial trigger points and passive accessory vertebral segments. These impairments are correlated with enhanced headache duration, headache-related disability, and signs of widespread pain sensitization. Reduction in active cervical movement and increased mechanical hyperalgesia of the cervical was consistent in ictal episodic migraine patients and the subgroups of episodic migraine patients with more pronounced widespread sensitization