Use of biological treatments in patients with hidradenitis suppurativa.

INTRODUCTION: Hidradenitis suppurativa (HS) is a chronic skin disease which causes a great impact in the quality of life. Multiple therapeutic options have been proposed, and recently the potential use of biological drugs in severe cases has been postulated. MATERIAL AND METHODS: A retrospective study from seven tertiary Spanish centers reviewing the charts of patients with HS treated with biological drugs was performed. Retrieved information included epidemiological data, clinical features, pain intensity, Hurley stage, laboratory data and therapeutic outcomes. RESULTS: Nineteen patients were included in the study; 10 men (52.6%) and 9 women. Eight patients (42%) showed a Hurley severity stage II and 11 a stage III (57.8%). Adalimumab was prescribed as the first biological treatment in nine out of 19 cases (47.3%), whereas infliximab was prescribed in seven cases (36.8%), ustekinumab in two cases (10.5%) and etanercept in one (5.2%). A complete response was observed in three patients (two cases with infliximab and one case with ustekinumab), a partial improvement in 10 patients and in six patients no clinical improvement was noted. One patient referred worsening of the skin symptoms. In 6 cases, a second biological treatment was prescribed. In three of such cases, a partial improvement was noted, whereas in three cases no clinical improvement was observed. In two cases a switch to a third biological drug was indicated, with a partial improvement in one case. DISCUSSION AND CONCLUSIONS: Biological drugs could be a potential and effective therapeutic option for patients with severe HS. Complete and persistent clinical responses are rarely obtained (15%) and partial responses are achieved in approximately 50% of patients. No specific markers for a therapeutic response have been identified. No definitive conclusions regarding the most effective biological drug for HS could be drawn. Higher dosage schedules seem to be associated with higher response rates. The lack of response of one particular drug does not preclude a potential efficacy to another biological treatment.

Evidence-based guidelines of the spanish psoriasis group on the use of biologic therapy in patients with psoriasis in difficult-to-treat sites (nails, scalp, palms, and soles).

Psoriatic lesions affecting the scalp, nails, palms, and the soles of the feet are described as difficult-to-treat psoriasis and require specific management. Involvement of these sites often has a significant physical and emotional impact on the patient and the lesions are difficult to control with topical treatments owing to inadequate penetration of active ingredients and the poor cosmetic characteristics of the vehicles used. Consequently, when difficult-to-treat sites are involved, psoriasis can be considered severe even though the lesions are not extensive. Scant information is available about the use of biologic therapy in this setting, and published data generally comes from clinical trials of patients who also had moderate to severe extensive lesions or from small case series and isolated case reports. In this article we review the quality of the scientific evidence for the 4 biologic agents currently available in Spain (infliximab, etanercept, adalimumab, and ustekinumab) and report level i evidence for the use of biologics to treat nail psoriasis (level of recommendation A) and a somewhat lower level of evidence in the case of scalp involvement and palmoplantar psoriasis.

Compounding as a current therapeutic option in dermatology.

Compounding continues to play a key role in the treatment of skin conditions, despite the abundance of products made by the pharmaceutical industry. Right from the earliest days of dermatology, compounding proved very useful in the treatment of diseases for which no specific drugs were available. However, as new products came onto the market, this usefulness was called into question, and doubts over safety, stability, and effectiveness were raised. Today, compounding is regaining the place it once held in routine dermatological practice. We review the advantages and disadvantages of compounding, the most common indications, current legislation in our setting, and the latest developments in active ingredients and vehicles.

Spanish evidence-based guidelines on the treatment of psoriasis with biologic agents, 2013. Part 1: on efficacy and choice of treatment. Spanish Psoriasis Group of the Spanish Academy of Dermatology and Venereology.

Biologic therapy is a well-established strategy for managing moderate and severe psoriasis. Nevertheless, the high cost of such therapy, the relatively short span of clinical experience with biologics, and the abundance of literature now available on these agents have made evidence-based and consensus-based clinical guidelines necessary. The ideal goal of psoriasis treatment is to achieve complete or nearly complete clearing of lesions and to maintain it over time. Failing that ideal, the goal would be to reduce involvement to localized lesions that can be controlled with topical therapy. Although current evidence allows us to directly or indirectly compare the efficacy or risk of primary or secondary failure of available biologics based on objective outcomes, clinical trial findings cannot be directly translated to routine practice. As a result, the prescribing physician must tailor the treatment regimen to the individual patient. This update of the clinical practice guidelines issued by the Spanish Academy of Dermatology and Venereology (AEDV) on biologic therapy for psoriasis incorporates information from the most recent publications on this topic.

Clinical and therapeutic evaluation of patients with moderate to severe psoriasis in Spain: the secuence study.

BACKGROUND: Evaluation of disease severity is considered essential in the optimal management of psoriasis. OBJECTIVES: To describe the clinical characteristics and therapeutic profile of patients with moderate to severe psoriasis in Spain and to assess the impact of the disease on the patients' quality of life. MATERIALS AND METHODS: This was an observational, cross-sectional study carried out in 90 dermatology units in Spain in 2009. We included 442 patients diagnosed with moderate to severe psoriasis who had started treatment with systemic agents, phototherapy, and/or topical treatments between 2004 and 2006. RESULTS: More severe psoriasis was significantly associated with the following: longer disease duration; higher prevalence of concomitant disease; greater involvement of the nails, scalp, flexures, palms, and soles; and poorer quality of life. In the 5 years before the start of the study, 68% of the patients had received conventional systemic treatments, 39.1% biologic agents, and 22.3% phototherapy. At present, 57.5% of the patients are being treated with biologic agents, 32.6% with conventional systemic treatments, and 11% with phototherapy. CONCLUSIONS: Severity of psoriasis was associated with a marked impact on quality of life. Regardless of disease severity, psychiatric comorbidity was the strongest predictor of poor quality of life. On average, patients had received other treatments, such as conventional systemic treatments or phototherapy, for more than 2 years before switching to biologic agents for the first time.

Clinical and Therapeutic Evaluation of Patients with Moderate to Severe Psoriasis in Spain: The Secuence Study. / Evaluación clínica y terapéutica de los pacientes con psoriasis moderada o grave en España. Estudio Secuence.

BACKGROUND: Evaluation of disease severity is considered essential in the optimal management of psoriasis. OBJECTIVES: To describe the clinical characteristics and therapeutic profile of patients with moderate to severe psoriasis in Spain and to assess the impact of the disease on the patients' quality of life. MATERIALS AND METHODS: This was an observational, cross-sectional study carried out in 90 dermatology units in Spain in 2009. We included 442 patients diagnosed with moderate to severe psoriasis who had started treatment with systemic agents, phototherapy, and/or topical treatments between 2004 and 2006. RESULTS: More severe psoriasis was significantly associated with the following: longer disease duration; higher prevalence of concomitant disease; greater involvement of the nails, scalp, flexures, palms, and soles; and poorer quality of life. In the 5 years before the start of the study, 68% of the patients had received conventional systemic treatments, 39.1% biologic agents, and 22.3% phototherapy. At present, 57.5% of the patients are being treated with biologic agents, 32.6% with conventional systemic treatments, and 11% with phototherapy. CONCLUSIONS: Severity of psoriasis was associated with a marked impact on quality of life. Regardless of disease severity, psychiatric comorbidity was the strongest predictor of poor quality of life. On average, patients had received other treatments, such as conventional systemic treatments or phototherapy, for more than 2 years before switching to biologic agents for the first time.

Nail psoriasis: treatment with tazarotene 0.1% hydrophilic ointment.

INTRODUCTION: Nail involvement is common in psoriasis and has a considerable impact on patient quality of life. Its clinical presentation depends on which part of the nail is affected: the bed or the matrix. Fifty percent of patients report associated pain. In this study, we analyzed the safety and effectiveness of tazarotene 0.1% in a hydrophilic ointment in the treatment of nail psoriasis. MATERIAL AND METHODS: We performed an open observational study of 6 patients diagnosed with nail psoriasis. The patients applied a compounded preparation of tazarotene 0.1% ointment under occlusion every night for 6 months in their homes. They were not receiving any other topical or systemic treatments. Nail psoriasis severity (assessed using the Nail Psoriasis Severity Index [NAPSI]), subungual hyperkeratosis, onycholysis, splinter hemorrhages, oil stains, and nail pitting were evaluated at baseline and at 3 and 6 months. RESULTS: A statistically significant improvement between baseline and 6 months was observed in all patients: the mean (SD) NAPSI went from 14.3 (6.3; 95% CI, 11.74-16.92) to 2.3 (1.21; 95% CI, 1.84-2.3) while the median went from 15 to 2.5 (P = .007). The percentage improvement at the end of treatment was 87.9%. No adverse effects were observed. CONCLUSION: Our study shows the therapeutic potential of tazarotene ointment in nail psoriasis.

Serum prolactin levels in psoriasis and correlation with cutaneous disease activity.

BACKGROUND: Prolactin (PRL), a neuropeptide secreted by the anterior pituitary gland, possesses a variety of physiological actions. It has been implicated as an important immunomodulator and exerts a proliferative effect in cultured human keratinocytes via specific receptors. Some studies have indicated an increase in serum PRL levels in psoriasis and exacerbation of psoriasis when a prolactinoma is present. AIM: To evaluate the correlation between serum PRL levels and Psoriasis Area and Severity Index (PASI). METHODS: Serum PRL levels were measured in 20 patients (10 mean, 10 women, age range 18-88 years) with plaque-type psoriasis before and after a 6-week period of topical treatment with tacalcitol ointment. Results were compared with a group of 20 healthy volunteers. RESULTS: Serum PRL levels were significantly increased in the psoriatic group compared with the control group (P < 0.001) and were significantly reduced after treatment (P = 0.001). There was a correlation between pretreatment serum PRL levels and PASI (r = 0.33; P = 0.02). CONCLUSIONS: These results indicate that serum PRL levels may serve as a biological marker of psoriatic disease activity.

Nail psoriasis: a retrospective study on the effectiveness of systemic treatments (classical and biological therapy).

BACKGROUND: Nail psoriasis represents a challenge for specialists. There is no comparative study of systemic treatment's effectiveness at this site. OBJECTIVE: Evaluate the response of nail psoriasis to classical and biological therapy and to compare the effectiveness and safety of the different treatments. METHODS: We performed a retrospective study of 84 patients with moderate-severe psoriasis seen at our Department between January 2006 and January 2009. RESULTS: Psoriasis was severe in 53.4%. In 75% of cases, the fingernails were affected, and the mixed form was the most frequently subtype. The mean baseline scores on the PASI and the NAPSI were 23.12 and 14.7 respectively; the correlation between the two scores fell at weeks 12 and 24 but had risen again at week 48. The baseline NAPSI score tended to be lower in women and significantly higher in patients over 65 years of age, family history of psoriasis, severe psoriasis and nail matrix involvement. In our series, 58.3% received classical treatment (acitretin, methotrexate, cyclosporin, PUVA, NUVB, REPUVA, RENUVB) and 41.7% received biological treatment (infliximab, efalizumab, etanercept, adalimumab).Significant reductions were found (P < 0.05) in the mean NAPSI scores at 12, 24 and 48 weeks with all the antipsoriatic agents except NUVB; significantly greater with cyclosporine (P < 0.01) and biological as infliximab and adalimumab at 12 and 24 weeks (differences between treatments disappeared at 48 weeks). CONCLUSION: The response to treatment is slower in the nail lesions than in the skin lesions. The improvement of nail psoriasis is significant both with the classical treatments significantly higher in cyclosporin; and biological treatment (infliximab and adalimumab at 12 and 24 weeks).

[Narrowband UV-B, monochromatic excimer laser, and photodynamic therapy in psoriasis: a consensus statement of the Spanish Psoriasis Group]. / Documento de consenso de fototerapia en psoriasis del Grupo Español de Psoriasis: ultravioleta B de banda estrecha (UVBBE), láser y fuentes monocromáticas de excímeros y terapia fotodinámica.

Novel treatment strategies and new information concerning the management of moderate to severe psoriasis justify a reassessment of the role of the classic therapies in this setting. This consensus statement evaluates narrowband UV-B therapy, which is currently considered the phototherapy option of choice in psoriasis because of its risk-to-benefit ratio. The role of excimer laser and photodynamic therapies are also discussed. These targeted therapies are still only available in a small number of centers in Spain and are used principally in the treatment of localized and recalcitrant forms of psoriasis. We discuss the efficacy and safety of phototherapy as well as treatment regimens, combination therapy, and clinical considerations relating to the characteristics of the patient or the disease.

[Clinical characteristics and disease course in patients treated with efalizumab following suspension of marketing authorization by the European medicines agency: a multicenter observational study]. / Perfil clínico y curso evolutivo de los pacientes tratados con efalizumab tras la suspensión de su autorización por la EMEA. Estudio observacional y multicéntrico.

BACKGROUND AND OBJECTIVES: The withdrawal of marketing authorization for efalizumab by the European Medicines Agency in February, 2009 provided a unique opportunity to assess the course of disease in patients who were not subject to the selection criteria and biases that were common in the pivotal trials. The aim of this study was to evaluate the course of psoriasis following forced suspension of efalizumab in a group of patients treated in normal clinical practice. As secondary objectives, we sought to assess the relationships between clinical characteristics, treatment response, and disease course during efalizumab treatment and 12 and 24 weeks after suspension. PATIENTS AND METHODS: Information on the epidemiological profile and disease course during treatment and following suspension of the drug was collected from a group of patients treated with efalizumab. Statistical analyses were performed to identify predictive factors. RESULTS: One hundred forty-seven patients from 12 Spanish hospitals were included in the study. During treatment, 4% of patients were diagnosed with generalized inflammatory flares. Most patients could be classified as having a good (55%) or moderate (18%) response to treatment. Rebound following withdrawal of efalizumab was observed in 30% of patients. The likelihood of rebound was independent of clinical characteristics, treatment response, or therapeutic approach used by the dermatologist following suspension. CONCLUSIONS: There was a high frequency of rebound following suspension of efalizumab, exceeding the rate reported in pivotal trials. This is particularly noteworthy given the large proportion of patients with a good response to treatment and therefore believed to have a better prognosis. Other significant findings were the higher frequency of positive treatment response than observed in previous studies (possibly influenced by the mean treatment duration) and the high frequency of generalized inflammatory flares.

[Adverse reactions during biological therapy for psoriasis: results of a survey of the Spanish Psoriasis Group]. / Efectos adversos observados durante la terapia biológica en la psoriasis. Resultados de una encuesta al Grupo Español de Psoriasis.

BACKGROUND: Biologic therapies have been a major breakthrough in the treatment of psoriasis because they are more selective and have a better short-term and medium-term safety profile. There are reliable data to support both the efficacy and the safety of these drugs. However, it is always useful to report the clinical experience of dermatologists who are experts in the use of biologic agents to treat psoriasis, particularly with regard to their safety. MATERIAL AND METHODS: We present the results of a survey administered to the members of Spanish Psoriasis Group and based on a series of questions referring to the clinical safety of these agents. A total of 988 patients treated with efalizumab, infliximab, etanercept, and adalimumab were reported by 15 members of the group. RESULTS: There was a particularly high proportion of reactions (34%) to infliximab infusions. Blood test abnormalities were detected in 13.25% of patients and infections in 12.24%, with one case of pulmonary tuberculosis. Attention is drawn to the adverse effects profile of efalizumab: de novo arthritis in 5.8% and rebound in 20.9% of patients. CONCLUSION: The safety data provided by our study should be taken into account in view of the large number of patients recruited by dermatologists experienced in the use of this type of therapy.

[Guidelines on the use of methotrexate in psoriasis]. / Metotrexato: guía de uso en psoriasis.

Psoriasis, a chronic multifactorial inflammatory disease that develops in genetically predisposed individuals, affects approximately 1.5% of the Spanish population. This disease has a negative impact on patients' quality of life, and long-term therapy is often required to control the symptoms. In addition to the classical systemic treatments (methotrexate, acitretin, cyclosporine, and ultraviolet light), the group of drugs known as biologics (etanercept, infliximab, adalimumab, and ustekinumab) provides the dermatologist with an expanded therapeutic armamentarium, thereby improving the likelihood of controlling psoriasis in patients with severe and/or extensive disease. Methotrexate, a classic antipsoriatic drug, is still very useful either as single-drug therapy or in combination with other systemic drugs, particularly as a rescue therapy or combined with biologics. This article aims to establish the role of methotrexate in the treatment of psoriasis. We considered it of interest to develop guidelines for using methotrexate in the management of psoriasis with a view to ensuring the safe and proper use of this drug in the management of psoriasis. This document was developed by consensus among members of the Psoriasis Group of the Spanish Academy of Dermatology and Venereology.

Guidelines on the Use of Methotrexate in Psoriasis. / Metotrexato: guía de uso en psoriasis.

Psoriasis, a chronic multifactorial inflammatory disease that develops in genetically predisposed individuals, affects approximately 1.5% of the Spanish population. This disease has a negative impact on patients' quality of life, and long-term therapy is often required to control the symptoms. In addition to the classical systemic treatments (methotrexate, acitretin, cyclosporine, and ultraviolet light), the group of drugs known as biologics (etanercept, infliximab, adalimumab, and ustekinumab) provides the dermatologist with an expanded therapeutic armamentarium, thereby improving the likelihood of controlling psoriasis in patients with severe and/or extensive disease. Methotrexate, a classic antipsoriatic drug, is still very useful either as single-drug therapy or in combination with other systemic drugs, particularly as a rescue therapy or combined with biologics. This article aims to establish the role of methotrexate in the treatment of psoriasis. We considered it of interest to develop guidelines for using methotrexate in the management of psoriasis with a view to ensuring the safe and proper use of this drug in the management of psoriasis. This document was developed by consensus among members of the Psoriasis Group of the Spanish Academy of Dermatology and Venereology.

Patient and Physician Satisfaction with Calcipotriol and Betamethasone Dipropionate Aerosol Foam in the Treatment of Plaque Psoriasis on the Body. / Satisfacción del paciente y el médico con la espuma en aerosol de calcipotriol y dipropionato de betametasona para el tratamiento de la psoriasis vulgar en el cuerpo.

BACKGROUND AND OBJECTIVE: Calcipotriol and betamethasone dipropionate (Cal/BD) aerosol foam is more effective in the treatment of plaque psoriasis than earlier formulations incorporating this combination of active ingredients. The aim of this study was to evaluate patient and physician satisfaction with Cal/BD aerosol foam in the treatment of plaque psoriasis on the body. MATERIAL AND METHODS: Retrospective observational study of 446 patients with plaque psoriasis affecting no more than 30% of the body surface area who had received treatment with Cal/BD aerosol foam for 4 weeks. The patients rated their satisfaction with the treatment using the TSQM-9 (Treatment Satisfaction Questionnaire for Medication) and the physicians on a 5-point Likert scale. RESULTS: Patients were highly satisfied with Cal/BD aerosol in terms of its ability to treat their condition (84%), relieve their symptoms (84.4%), and act rapidly (82.8%). With respect to convenience, the patients gave high ratings to ease of use (91.8%), ease of planning (93.9%), and ease of following instructions (89.9%). Global satisfaction was also high, with 85% of patients expressing that they were satisfied, very satisfied, or extremely satisfied with the treatment. Of the physicians, 85.7% stated that they were quite or very satisfied with the treatment. CONCLUSION: Both patients and physicians expressed high satisfaction with the use of Cal/BD aerosol foam for the treatment of plaque psoriasis on the body.

Nail psoriasis: a combined treatment with 8% clobetasol nail lacquer and tacalcitol ointment.

BACKGROUND: Nail involvement is a common and distressing feature in the course of psoriasis. Although much progress has been made in the treatment of the disease, the presence of psoriasis in the nail continues to pose a challenge. In recent years, vitamin D3 analogs and a new formulation containing 8% clobetasol-17-propionate in a colourless nail lacquer vehicle have produced good results for the control of nail psoriasis. OBJECTIVE: To determine the efficacy and safety of the combined treatment of 8% clobetasol-17-propionate in a lacquer vehicle and tacalcitol ointment in nail psoriasis. METHODS: Fifteen patients with both nail bed and nail matrix psoriasis were included in the study. They were treated with a colourless nail lacquer containing 8% clobetasol-17-propionate applied at bedtime at the weekend, and with tacalcitol ointment under occlusion on the remaining days, for 6 months. RESULTS: All 15 patients responded well to treatment. The therapeutic effect was very fast and directly related to the length of therapy. All nail alterations, including nail pain, were reduced, and the modified target Nail Psoriasis Severity Index fell by an average of 78% compared to baseline levels (+/-59.6, P < 0.0001). CONCLUSIONS: Combined treatment with tacalcitol ointment and 8% clobetasol-17-propionate in a nail lacquer is a safe, effective treatment for nail bed and nail matrix psoriasis.

Optimization of narrow-band uvb with a 5% oleic acid cream in the treatment of psoriasis.

Oleic acid is a monounsaturated fatty acid with a known action of penetration enhancer which has been used for various purposes, such as a tanning increaser. Narrow-band ultraviolet B (UVB) is a also first-line treatment for psoriasis. The purpose of this study was to evaluate if the use of a 5% oleic acid emulsion previous to the phototherapy sessions was useful in reducing the total dosage necessary for whitening in patients with psoriasis. Forty-four patients were included, 24 received application of the emulsion before phototherapy and 20 received phototherapy with no emulsion. Patients received the UVB sessions just to achieve a reduction of 80% of the basal PASI. The total dose received and number of sessions were compared within the 2 groups. A reduction in these parameters (29.68 J/cm(2) vs. 18.16 J/cm(2); 24 vs. 19 sessions) was seen in the group that received application of the emulsion. However, this was not statistically significant. The fact that we did not achieve the statistical significance may be due to the small sample size. These results must be cautiously interpreted and confirmed with further studies.

Topical tacrolimus for the treatment of psoriasis on the face, genitalia, intertriginous areas and corporal plaques.

Tacrolimus is an immunosuppressive drug that has proved effective in the treatment of psoriasis when administered systemically. Topically, it seems only useful in thin psoriasis plaques located on the face, genitalia, and intertriginous areas. We present an open-label clinical trial to test the efficacy of 0.1% tacrolimus ointment in patients with psoriasis on the face, intertriginous areas, both, and in corporal plaques. Efficacy was assessed with the evaluation of erythema, desquamation, infiltration, reduction of the PASI, and reduction of itching. A total of 15 patients were enrolled in the study. In all the localizations evaluated, each of the signs (erythema, desquamation, and infiltration) showed a statistically significant improvement when compared to the baseline (p < .001). Itching also improved rapidly. PASI was also reduced from a mean of 12 at baseline to 2.2 at the end of the study. Of the 15 patients, only 2 experienced an adverse effect (13%), which was described as a warm sensation in facial lesions which was transient and self-limited. In conclusion, tacrolimus ointment may be an alternative to classical options for the treatment of psoriasis, not only for intertriginous, genital, and facial areas, but also for corporal plaques without occlusion, with good tolerance.

Clinical experience with the use of cyclosporin A in psoriasis. Results of a retrospective study.

The efficacy of cyclosporin A (Sandimmun Neoral) in severe psoriasis was analysed in 70 patients included in a retrospective descriptive study conducted at our Dermatology Department from January 1994 until December 2000. After 8 weeks of treatment, with an initial dose of 2.5-3 mg/kg/day, the reduction in the Psoriasis Area and Severity Index (PASI) score was>75% in 61% of patients. Most of the side effects observed turned out to be susceptible to being reversed over time or by dose reduction. The results of this study show that continuous and low-dose cyclosporin therapy is a safe and efficacious treatment for severe chronic psoriasis.