Patient preference study for different characteristics of systemic psoriasis treatments (Protimisis).

"The Protimisis" study was a multicenter, cross-sectional study investigating the relative importance and economic value that patients assign to different characteristics of systemic psoriasis treatments. Treatment preferences were investigated with the DCE methodology and patients had to decide over the most important aspects of different psoriasis treatments. A questionnaire regarding demographic data/medical history and the DLQI and EQ-5D-3L questionnaires were also completed. A total of 310 patients were included. Out of those, 37.4% reported using oral medications for psoriasis as their most recent treatment, while the remaining patients reported treatment with injections once per week (14.8%), injections twice per week (7.4%), injections once every three months (29.4%) and intravenous injections every two months (8.4%) as their most recent treatment. Mean DLQI score was 6.6 (SD 6.5), and in the EQ-5D-3L index, 71.0% of patients reported having problems with anxiety or depression. DCE analysis showed a clear preference for treatments with longer dosing intervals, rapid onset of action, lasting clinical response, low risk of SAEs and lower cost. The risk of SAEs was the most important treatment characteristic (54% of patients). Older patients showed less concern for safety matters than younger patients. The highest willingness-to-pay was recorded for treatments with longer dosing intervals and for safer treatment options.

A multicenter, prospective, observational study examining the impact of risk factors, such as BMI and waist circumference, on quality of life improvement and clinical response in moderate-to-severe plaque-type psoriasis patients treated with infliximab in routine care settings of Greece.

BACKGROUND: Obesity has been associated with moderate-to-severe plaque psoriasis severity and PASI 75 response attainment of biologic therapies, but findings are inconsistent. OBJECTIVE: This study aimed to examine the association of body mass index (BMI) and waist circumference (WC) on disease severity, to identify potential patient characteristics associated with response attainment and to assess the impact of infliximab on the patients' health-related quality of life (HRQoL) among infliximab-treated patients in the routine care setting of Greece. METHODS: This was a multicenter, prospective, observational study of adult moderate-to-severe plaque psoriasis patients who had initiated treatment with originator infliximab within 2 weeks prior to enrolment. Postenrolment visits occurred at 14 ± 4, 30 ± 4 and 54 ± 4 weeks following treatment onset. RESULTS: Between October 2012 and June 2014, 136 eligible patients (62.5% males) with a median age of 48.6 years, BMI of 29.6 kg/m2 and WC of 107.0 cm at enrolment were recruited by 21 dermatology hospital/private offices. All patients had received prior psoriasis treatment(s); 62.5% were biologic-naïve. Mean baseline psoriasis area severity index (PASI) and Dermatology Quality of Life Index (DLQI) scores were 23.4 ± 13.6 and 15.0 ± 8.3, respectively. A low correlation was observed between WC at enrolment and baseline PASI [ρ = 0.324 (P < 0.001)]. Over a median 48.4 weeks of infliximab exposure, 89.3% of the per protocol set achieved a PASI 75 response. At 14, 30 and 54 weeks, the PASI 75 attainment rate was 66.4%, 74.8% and 76.6%, respectively; the clinically meaningful DLQI improvement (≥5 point decrease) rate was 68.9%, 75.7% and 69.8%, respectively. BMI category and abdominal obesity at enrolment did not impact PASI 75 or DLQI improvement rate attainment. CONCLUSION: In the routine care of Greece, infliximab reduced disease activity and improved the quality of life of moderate-to-severe psoriasis patients through 1 year of treatment, independent of their BMI and WC.

High dose oral prednisone vs. prednisone plus azathioprine for the treatment of oral pemphigus: a retrospective, bi-centre, comparative study.

BACKGROUND: Steroids are considered the cornerstone in the treatment of pemphigus vulgaris. However, subsequent morbidity of their use has led to the development of combined therapeutic protocols, using steroid sparing agents. OBJECTIVES: The aim of this study was to compare tolerability and efficacy of high dose oral prednisone daily, vs. low dose oral prednisone on alternate days plus azathioprine every day (Lever's mini treatment: LMT) in oral pemphigus. PATIENTS AND METHODS: Data of 36 patients with oral pemphigus vulgaris, treated with either 1.5 mg/kg/day of oral prednisone daily, or LMT were re-evaluated and statistically analysed. Primary endpoints were time required to control disease activity, prednisone dose required until the end of consolidation phase, cumulative prednisone dose and rates of remission. Secondary endpoints were time to complete (CR) or partial remission (PR) on/off therapy, treatment-associated morbidity and days of hospitalization. RESULTS: Both treatments resulted in high rates of clinical response. The mean prednisone dose required until the end of consolidation phase, and until CR or PR, on/off minimal therapy, was significantly lower in LMT group. However, the mean time required until the control of disease activity and CR or PR, for the same group, was significantly higher. Adverse events were more frequent among patients under daily prednisone. Mean time of hospitalization was also longer in the latter group. CONCLUSIONS: Both treatments seem efficacious. Rapidly progressive lesions necessitate high prednisone dose for early and adequate control of the disease. Patients with impaired physical status, especially those with relatively stable lesions, at baseline might safely and effectively be treated with LMT.

Cutaneous alternariosis in an immunocompromised patient.

A case of cutaneous alternariosis in a 68-year-old male farmer is presented. The patient had been treated with prednisone and azathioprine for thrombocytopenic purpura, and two months later he noted multiple ulcerated and slightly infiltrated granulomatous lesions on exposed areas. The diagnosis was confirmed by results of direct examination, culture of biopsy material, and histologic examination. A concurrent herpetic infection healed without sequelae. The protracted course of our patient's condition and a review of the literature suggest the tapering or stopping of steroids as the first step in the successful and permanent treatment of cutaneous alternariosis.

A comparison of itraconazole and griseofulvin in the treatment of tinea corporis and tinea cruris: a double-blind study.

A total of 40 patients with clinically and mycologically documented tinea corporis or tinea cruris were treated with 100 mg/day itraconazole (n = 19) or 500 mg/day griseofulvin (n = 21) for 15 days. Of the itraconazole-treated patients, 83.3% were healed or markedly improved, i.e. 'responders', after 15 days compared with 85.7% of griseofulvin-treated patients. At 15 days after the end of treatment, 88.2% of itraconazole- and 80.9% of griseofulvin-treated patients were classed as 'responders'. The mycological cure rate (both microscopy and culture negative) was generally lower than the clinical response rate. Both treatments were equally effective at the end of 15 days' treatment with 66.7% of patients cured, but itraconazole was superior to griseofulvin at the 15-day follow-up visit (77.8% of itraconazole-treated patients compared with 66.7% of griseofulvin-treated patients were cured). Both therapies were well tolerated; only one patient treated with itraconazole reported minor side-effects (dizziness, headache and gastro-intestinal disturbances). The results confirm those of earlier comparative trials and suggest that griseofulvin-treated patients are more at risk of relapse than are itraconazole-treated patients.

Prevention of malignant melanoma.

The results of Primary Prevention programs, aiming at the decrease of melanoma incidence, were less encouraging than those of Secondary prevention which aims at an early diagnosis of malignant melanoma. Australia was the country with the best results obtained in both Prevention strategies, especially in avoiding intense, though intermittent, UV exposure. The success of these programs encouraged health authorities to initiate their application to other disorders. New sunscreens containing substances correcting the UV-damaged DNA may offer a promising result in the decades to come. However, so far no one epidemiological study has proved the prevention of malignant melanoma with the use of sun protecting agents. A meta-analysis verified the connection between melanoma and solarium use. The protective role of vitamin D in the development of prostate, breast and colon cancer was shown in a meta-analysis. The authors, however, suggest that fair-skinned persons should take oral supplementation of vitamin D, instead of exposing themselves to the sun. The Hellenic Society of Dermatology and Venereology published the results of 5-year-prevention programs in Greece. Their favorable results in the early diagnosis of melanoma justify an intense continuation of these efforts.

An alternate-day corticosteroid regimen for pemphigus vulgaris. A 13-year prospective study.

BACKGROUND: Pemphigus vulgaris (PV) at the early, usually oral and relatively stable stage, represents the majority of PV patients. Treatment modalities usually do not differ compared to those for the fully established disease. OBJECTIVES: To prospectively assess a standardized and effective therapeutic approach that aims at less morbidity due to adverse reactions. METHODS: The following regimen, also known as Lever's mini treatment (LMT), was used. Forty mg of oral prednisone on alternate days plus 100 mg azathioprine every day were administered until the complete healing of all lesions. A gradual monthly and later bimonthly decrease of prednisone was followed by the tapering of a second immunosuppressive agent, in a one-year period. RESULTS: Seventy-four patients suffering from early-stage-PV, and representing 70% of all PV patients seen through the years 1991-2003, were eligible in the study. Total follow-up period was 76 +/- 37 (26-180) months. During the 53 +/- 26 months of LMT, 6 (8%) patients dropped out of therapy, 9 (12%) required a change to another treatment, two (3%) died and 57 (77%) achieved a lesion-free condition. Forty-five (61%) patients were in complete remission for 27 +/- 29 months. Significant morbidity was estimated 4/74 (5.2%). Disease 'breakthroughs' necessitating treatment adjustments occurred in 30 patients, usually throughout the last phase of therapy and post-treatment follow-up. CONCLUSION: LMT may be a standardized therapeutic approach for the early and relatively stable stage of PV, resulting in high efficacy, safety and quality of life profile.

Intermittent vs. continuous 1-year cyclosporin use in chronic plaque psoriasis.

OBJECTIVE: To comparatively assess the impact of intermittent and continuous cyclosporine (CyA) administration in chronic plaque psoriasis. METHODS: A two-step procedure was followed for the 51 patients who were randomly assigned in the study. CyA in doses 2.5 mg kg(-1) day(-1) escalated up to 5 mg kg(-1) day(-1) for efficacy reasons, were given to all patients during the initial 12-week step. Only patients who achieved a minimum 50% reduction of baseline PASI could enter the 2nd step, which lasted for nine additional months. Subjects on the intermittent schedule stopped all therapy to receive other 12-week course(s) if and when they relapsed. Patients on the continuous schedule continued CyA therapy at the lowest, individualized, effective dose. RESULTS: 78% of all patients achieved a PASI-75, with subjects on continuous treatment manifesting greater improvement (92% vs 62%, P= 0.008). The decrease of DLQI was 89%, without any difference between the two schedules (P= 0.214). The median effective and maintenance doses were 3 (2.5-3.8) and 1.8 (0.7-3) mg kg(-1) day(-1), respectively for intermittent and continuous schedules. A significant correlation was observed between the clinical parameters and DLQI change at 1 year, for both groups of patients. Dose modifications for safety reasons were necessary in 5 patients, but no treatment discontinuation was required. Patients on the continuous regimen received 139% of the mean cumulative annual CyA dose of Intermittent therapy. CONCLUSION: The significantly higher annual cumulative dose required for the continuous CyA regimen compared to intermittent, leads to the suggestion that the first modality may offer higher physical improvement but must remain an option for those patients who do not respond or are uncooperative with intermittent CyA use.

Radical excision and mesh-skin grafting for giant anorectal condyloma acuminatum.

BACKGROUND Giant Condyloma Acuminatum (GCA) presents difficulties in therapeutic management, mainly due to local invasion and recurrences. Treatment measures vary from topical agents to aggressive methods such as surgical excision, radiation, laser surgery, chemotherapy, immunotherapy or their combination. METHOD A 48-year-old heterosexual, HIV-negative male with a 20 year-year history of GCA, following an unsuccessful surgical operation, underwent radical excision with immediate mesh-skin grafting. CONCLUSION The absence of relapse and the excellent cosmetic results obtained one and a half years post-operative may put this treatment option in the first line of treatment choices for GCA

Impetigo herpetiformis: menstrual exacerbations for 7 years postpartum.

Impetigo herpetiformis (IH) is a rare pustular dermatosis that shares striking clinical and histological similarities to generalized pustular psoriasis. The case of a 26-year-old primigravida with IH progressing in the 30th week of her pregnancy is presented. The peculiarity of our presentation relies on the reappearance of the disease postpartum. Monthly exacerbations during menstruation lasted for 7 years. Some probable clues regarding the pathogenesis of IH are suggested.

The treatment of pemphigus vulgaris. Experience with 48 patients seen over an 11-year period.

We present a retrospective analysis of 48 patients with pemphigus vulgaris (PV) who were seen between 1978 and 1988. They were divided into three treatment groups: 25 (group A) received 40-100 mg of oral prednisone daily; eight (group B) received > 100 mg of prednisone daily; 15 (group C) received 40 mg of oral prednisone every other day and azathioprine 100 mg daily. A second immunosuppressive agent was subsequently added to the treatment regimen of three patients in group A and eight patients in group B. By 1989, 10% of the patients had been able to discontinue all therapy, and were in complete remission. Sixty-five per cent of patients were on maintenance therapy, but in clinical remission. Twenty-five per cent of the patients had died [eight in group A (31%) and four in group B (50%)] either as a consequence of the disease or its treatment. None of the patients in group C had died. Most of the deaths occurred during the first 2-3 months of therapy. Morbidity and mortality were related to the severity of the disease, to the maximum dose of prednisone required to induce remission, and to the presence of other diseases. Patients needing a total of 5 g or more of prednisone to induce a remission during the acute stage had a high mortality rate.

Tinea capitis in adults during 1981-95 in northern Greece.

The mycological laboratory of our Hospital examined 31,073 patients between 1981 and 1995. Sex, age, the residence of patients, the clinical type of tinea and contacts with other persons and animals were investigated. All the patients were also examined under Wood's light. Tinea capitis was diagnosed in 35 adults. Trichophyton violaceum was the commonest aetiological agent (54.5%), especially in elderly women. The other anthropophilic fungi were T. rubrum (8.5%), T. schoenleinii (5.7%) and T. tonsurans (2.8%). The zoophilic fungi Microsporum canis (14.3%), T. terrucosum (8.5%) and T. mentagrophytes (5.7%) were also isolated.

Steroid-pulse therapy in pemphigus vulgaris long term follow-up.

BACKGROUND: Patients with pemphigus vulgaris may occasionally present the highly active, widespread form of the disease, and/or maybe resistant to conventional oral steroid therapy, and/or manifest significant side effects from the prolonged use of high oral prednisone dosage. Our purpose was to evaluate the efficacy of steroid "pulse" therapy (PT) in these patients. METHODS: Eight patients were given alternate-day, one hour, infusions of 8, 9, or 10 mg/kg methylprednisolone Na succinate. Oral prednisone and a second immunosuppressive agent were simultaneously administered; these were rapidly decreased when control of the disease was achieved. RESULTS: All patients initially responded well to therapy. The disease recurred in four patients after 3, 4, 9, and 16 months of remission, respectively. Three of these patients were treated again with PT and went into remission. None of the patients who received cyclophosphamide had a recurrence. One patient died of cardiac arrest, 12 days after PT. On a follow-up of 59 +/- 25 months since the last relapse, patients continue in remission. CONCLUSIONS: Pulse therapy is recommended as an adjunct to the total management plan of severely affected patients with pemphigus vulgaris. The addition of cyclophosphamide may prevent the disease from recurring. Alternate-day small-quantity bolus infusions over 16-20 days, may be equally effective as the administration of 15 mg/kg/daily for 3-5 days. The risk of cardiac arrest exists even with this, less aggressive form of PT therapy. A medical history of supraventricular arrhythmias may be considered a risk factor.

Plasmapheresis in toxic epidermal necrolysis.

BACKGROUND: The treatment of toxic epidermal necrolysis (TEN) is usually based on the removal of the offending drug(s), fluid replacement, nutritional support, and local management. The mortality and morbidity, however, remain high and the death rate may be reduced to 10% only in special centers that use biologic dressings. Plasma exchange (PE) was proven efficacious in small series of patients and of no particular value in others. METHODS: Seven patients suffering from severe TEN covering 30%-80% of body surface area and having two or four mucous membranes involved, were included in this open study. Malignancy (Hodgkin's disease, brain tumor) and a variety of medicaments (carbamazepine, allopurinol, diphenylhydantoin, cefaclor, amoxicyllin with clavullanic acid) were considered as causally implicated. One to four PEs of 2.5 L were given on alternate days in six patients and on a daily basis in the seventh. RESULTS: All patients recovered successfully from their disease. No new lesions appeared after the first PE in four patients. Neither adverse reactions from this therapy nor sequelae from TEN were observed after a long follow-up lasting up to 8 years. CONCLUSIONS: Although PE is expensive and requires easy venous access to be performed, it could be listed in the first line of TEN therapy. The method is safe and efficacious, providing prompt relief from pain and rapid cessation of necrolysis. The alternate day PEs are considered preferable to the everyday regimen.

Value of routine diagnostic criteria of bullous pemphigoid.

BACKGROUND AND DESIGN: The clinical, histologic, and direct (DIF) and indirect (IIF) immunofluorescence findings are used in a critical, although arbitrary, manner in the routine diagnostic process of bullous pemphigoid (BP). Our purpose was to estimate their relative value. In the present retrospective study, a follow-up of at least 18 months was used as a prerequisite for the final diagnosis of BP (63 patients) and controls (n=159). RESULTS: The clinical, histologic, DIF, and IIF diagnostic criteria of BP were found to vary independently of each other. Positive DIF was the most sensitive (90.5%) typical for BP histology and positive IIF were the most specific (99%). Immunopathologic tests were the most valuable, especially in the atypical varieties of BP. Nearly 25% of patients in this group would have been misdiagnosed if IF tests had not been performed. Atypical cases (40%) seemed to represent a clinical continuum over the whole spectrum of the disease. Patients with exclusively immunoglobulin G (IgG) and C3 basal membrane zone (BMZ) deposits were significantly more often seropositive than the rest of the DIF-positive cases; however, the class of BMZ immunoreactants varied according to the site of biopsy. C3 was almost invariably deposited at the BMZ of DIF-positive patients. When Igs were also present, they were only exceptionally (5% of cases) of greater fluorescence intensity than C3. CONCLUSIONS: The combination of clinical data plus one positive immunopathologic test provide the best combination of sensitivity and specificity (98%), and seem to be most appropriate in defining patient populations for study purposes. The relationship between the classes of immunoreactants should be better evaluated with reference to the site of skin biopsy. It may be suggested, however, that the likelihood of BP existence is very low when in vivo C3 is absent or of lower intensity of fluorescence than the concomitant Ig(s).