Oral lichen planus: therapy and phenotype.

BACKGROUND: Lichen planus (LP) is a mucocutaneous disease of chronic inflammatory nature. Although many therapeutic options are available, none are curative. The aim of this article was to describe a therapeutic algorithm that take into consideration the clinical futures of oral LP (OLP). METHODS: Patients affected by symptomatic OLP were enrolled into three groups to receive cyclosporine mouthwash, retinoic acid lotion 0.05%, and autologous platelet-rich plasma (PRP) gel in the treatment of reticular, plaque-like, and erosive-type respectively. The products were applied as follows: retinoic acid BID for 8 weeks, cyclosporine mouthwash OD for 8 weeks, PRP once a week for 8 weeks. Patients were assessed at 2, 4, 8, and 12 weeks. Improvement was evaluated as complete response, partial response and no response. RESULTS: A total of 20 Caucasian patients, 8 male and 12 female, mean age 56 years (range 40-74) concluded the study. Seven patients showed a complete response, 7 patients a partial response, and 6 patients no response. CONCLUSIONS: We propose a therapeutic algorithm that take into consideration the clinical features and symptoms of OLP. Long-term experience on larger series of cases are necessary to confirm our data.

New therapeutic approaches in the treatment of anogenital lichen sclerosus: does photodynamic therapy represent a novel option?

BACKGROUND: Lichen sclerosus et atrophicus (LSA) is an inflammatory, mucocutaneous disorder that affects male and especially female with a debilitating impact on the quality of life. Common localization is the anogenital area. If not treated LSA can leave scars, functional impairment and can evolve in squamous cell carcinoma. The first line of treatment is represented by topical, ultra-potent corticosteroids, but often patients are unresponsive; moreover this therapy is frequently associated to relapses of the disease after discontinuation. METHODS: In this prospective observational study, the efficacy of three different treatments - topical calcineurin inhibitors, avocado and soya beans extracts, and methyl aminolevulinate photodynamic therapy (MAL-PDT) - was evaluated, and an effort has been made to define a therapeutic algorithm according to the severity of the disease. RESULTS: Of the 150 patients who were referred to the outpatient clinic for a dermatological and gynecological visit, 33 met the inclusion criteria. Sixteen (88%) patients showed an improvement of the lesion and a reduction of the itch; 3 (16.7%) patients with sever itch and fissurated lesions were evaluated for the MAL-PDT therapy. A total of 9 patients, after accurate examination of the lesions, were treated with MAL-PDT. The totality of the patients experienced a resolution of the lesions. CONCLUSIONS: In the early stages the use of ASE can represent a valid alternative that is well tolerated by the patients reducing the itching, dryness and improving the mucosal texture. The use of MAL-PDT represents a valid treatment in the moderate-severe stages of LSA.

Living with Chronic Spontaneous Urticaria in Italy: A Narrative Medicine Project to Improve the Pathway of Patient Care.

Chronic spontaneous urticaria (CSU) is perceived as a difficult to manage disease with negative impact on quality of life. The aim of this study was to highlight how to improve the care of people with CSU, using the methodology of narrative medicine. From June 2014 to March 2015, CSU-diagnosed patients and their physicians were asked to record their experiences of the condition in writing. Fourteen healthcare teams participated: 41% considered CSU as a challenge to overcome, while 22% experienced CSU as a big commitment. The number of professional involved was evaluated as insufficient in 11 hospitals. Seventy-five percent of the 190 Italian patients had visited 3 or more physicians before receiving a final diagnosis, with a perceived waste of time and resources. The therapeutic pathways were described as unsatisfactory in 83% of cases. As a result, anger and frustration were life-dominant emotions in 92% of patients. The critical points of the care pathway are related to organizational issues and lack of awareness.

Atopic dermatitis and dental manifestations.

BACKGROUND: Atopic dermatitis is a chronic skin disease associated with epidermal dysfunction commonly seen in children. The aim of this study was to evaluate the possible correlation between atopic dermatitis and dental diseases in paediatric patients. METHODS: An observational study was conducted by the Department of Paediatric Dentistry of the Policlinico Tor Vergata among a group of 300 children, between 2 and 17 years of age and of both genders, for a period of 6 months from January 2013 to June 2013. Socio-demographic data including race, gender, and age were collected. Clinical and dermatological examinations were performed in all patients; family and medical history of atopy was recorded for each patient and relatives. RESULTS: Three hundred patients, aged between 2 and 17 years, with mean age of 8.9 (±2.12), were enrolled; 90/300 (30%) were affected by atopic dermatitis. Of those, 69/90 (76.6%) had a medical history of spoil habit, 49/90 (54%) had caries, 58/90 (64.4%) had malocclusion disease, 13/90 (14.4%) had anatomical dental abnormalities. CONCLUSIONS: In conclusion, in the current investigation we found a higher prevalence of atopic dermatitis in pediatric dentistry patients compared to the general population suggesting that dental diseases could be involved in the pathogenesis of AD.

Efficacy and safety of infliximab in psoriatic patients over the age of 65.

BACKGROUND: Clinical data on the long-term safety and efficacy of infliximab on psoriatic patients who are older than 65 years are limited. OBJECTIVES: The aim is to report the long-term efficacy, safety and tolerance of infliximab in geriatric patients. METHODS: This was a retrospective study conducted at the Department of Dermatology of the University of Rome Tor Vergata. Clinical data were reported at week 12, 52, 104, 208. RESULTS: 151 charts were evaluated. A total of 27 patients were included. Range of the age was between 65 and 85 years; mean age was 73 years ±5.4; female to male ratio was 1:2; mean age of onset of psoriasis was 43 years±17. The average of treatment duration was 39 months ±27 (range 1-100). Fourteen patients suffered from plaque type psoriasis and 13 from psoriatic arthritis. At the baseline the mean PASI score was 15.6 ± 10.2. At week 12, 52, 104, and 208 the mean PASI was 2, 2.3, 1.9 and 1.8 respectively. A reduction in the mean PASI was maintained in the long-term treatment in 12 patients (p < 0.001). CONCLUSION: Our data suggest that long-term treatment with infliximab is effective and safe in patients over 65 years old and that IV therapy is also associated with a high compliance.

No meaningful association between suicidal behavior and the use of IL-17A-neutralizing or IL-17RA-blocking agents.

INTRODUCTION: An emerging class of agents blocking IL-17 signaling represents a very promising therapeutic approach. One of these agents, brodalumab, has been associated with an increased risk of suicide behavior. Areas covered: This review sought to provide an overview strictly focused on suicide behavior signals related to the use of IL-17 agents. Data collection regarding this peculiar safety aspect was primarily based on: (i) a revision of safety outcomes belonging to phase II and phase III trials; (ii) a systematic search using the Pubmed Medline database; and (iii) collecting recent data issued as posters or communications in eminent international meetings. Expert opinion: Whilst secukinumab and ixekizumab were not associated with increased signal of suicidal behavior, being recently approved for the treatment of psoriasis by EMA and FDA, brodalumab raised concern because of suicide behavior cases that led to pause momentarily its development program during pre-marketing stage before obtaining the positive recommendation by an FDA advisory panel for its approval. Indeed, a careful re-evaluation of brodalumab safety profile is being performed and no evidence clarified a significant association or a pathogenic mechanism linking brodalumab treatment to the risk of suicidal behavior, suggesting that cases of suicidal behavior accidentally occurred during brodalumab trials.

Pharmacodynamic assessment of apremilast for the treatment of moderate-to-severe plaque psoriasis.

INTRODUCTION: Psoriasis is a chronic inflammatory skin disease affecting 2-3% of the population. Certain systemic drugs currently available for its treatment could be associated, in the long term, with organ toxicity and adverse events, thus, clinical monitoring throughout treatment is required. Moreover, tolerability issues, parenteral administration, and barriers to patient access, such as high cost and specialist management lead to treatment failure. AREAS COVERED: Apremilast is an oral small molecule inhibitor of phosphodiesterase 4 (PDE4i). PDE is the major enzyme class responsible for the hydrolysis of cyclic adenosine monophosphate in immune cells (cAMP). With PDE4 inhibition, apremilast works intracellularly to modulate pro-inflammatory and anti-inflammatory mediator production critically involved in psoriasis. The aim of this paper is to focus the attention on apremilast pharmacodynamics effects, its efficacy and safety in treating moderate-to-severe plaque psoriasis. EXPERT OPINION: Apremilast is an effective and well-tolerated option in treating moderate-to-severe plaque psoriasis. Its safety profile and the oral administration offer significant advantages in prescribing apremilast for the treatment of psoriasis, particularly in some subsets of patients.

Small molecules and antibodies for the treatment of psoriasis: a patent review (2010-2015).

INTRODUCTION: Psoriasis is a chronic condition whose therapeutic armamentarium is increasingly being discussed, particularly when compared to past decades. The use of biologic agents has profoundly changed the history of this disease, as well as the management of psoriatic patients. Due to the enormous interest in psoriasis, as demonstrated within the scientific community and pharmaceuticals, new therapeutic targets have been identified and novel patented therapeutics are being tested. AREAS COVERED: This review sought to give an overview of small molecules and antibodies patented in the last five years for the treatment of psoriasis. Therapeutic agents either in the early or advanced phase of development have been described, primarily based on a systematic search using the PubMed Medline database. EXPERT OPINION: Though the recent introduction of new antipsoriatic agents has facilitated the management of long-term psoriasis, there is still a strong desire for alternative therapeutic options. Indeed, there remain unmet needs regarding safety and efficacy of psoriasis treatment that should be addressed. In this context, recently patented drugs may prove valid, interesting, and promising within the therapeutic paradigm.

UVA1 Laser in the Treatment of Vitiligo.

OBJECTIVE: The purpose of this article was to evaluate the clinical efficacy and safety of a monochromatic 355 nm ultraviolet (UVA) laser in the treatment of vitiligo. BACKGROUND DATA: Broadband and narrow-band UV phototherapy has been proposed as an effective therapeutic option in vitiligo patients. METHODS: Seventeen consecutive, unselected patients (7 men and 10 women) were enrolled in an open-label, prospective study and treated twice weekly for 8 weeks at a fixed dose of 80-140 J/cm(2). Follow-up was 12 weeks. RESULTS: Clinical repigmentation was observed in 15/17 patients (88.23%), with limited side effects (mild post-treatment erythema and itching). Results were maintained during the 12 week phototherapy-free follow-up period. CONCLUSIONS: the present report suggests that UVA1 laser could be an applicable therapeutic option in patients with vitiligo.

Serum Protein Profile Changes in Psoriatic Patients Undergoing Treatment With Infliximab.

UNLABELLED: The therapeutic paradigm in psoriasis includes antitumor necrosis alpha agents that have been proved effective and safe as long-term therapy. Recently, it has been described a correlation between the use of biologic agents and the occurrence of monoclonal gammopathies, which are haematological conditions characterized by clonal plasma cells proliferation producing a monoclonal immunoglobulin that accumulates in the blood. OBJECTIVE: The aim of this study is to detect electrophoretic abnormalities in psoriatic patients undergoing treatment with infliximab. RESEARCH DESIGN AND METHODS: A retrospective study evaluating all charts from the clinic database of all patients treated with infliximab. The evaluation of serum protein profile is routinely performed in the clinical setting during biologic therapies. We reported the occurrence MGUS in infliximab-treated patients. RESULTS: The study analysis included 141 charts. Overall, 23 patients showed a MGUS in their electrophoretic profile, though in 6 cases MGUS was detected at the baseline. Thereby, 17 cases (12.06% of the study population) developed MGUS during infliximab therapy. CONCLUSIONS: Serum protein electrophoresis test represents a useful tool to detect and monitor any potentially harmful condition that could occur during treatment with a biologic agent. Particularly, it could be crucial for the detection of MGUS, which does not affect clinical response, and it does not represent a criteria to withdraw the treatment.

A new therapeutic for the treatment of moderate-to-severe plaque psoriasis: apremilast.

Psoriasis is a common, chronic, inflammatory skin disease. Being a life-long condition, a prolonged and safe control of the disease is needed. Current anti-psoriatic treatments show some limits in terms of tolerability and route of administration. Recently, a new oral small molecule, apremilast, has been approved for the treatment of patients with moderate-to-severe plaque psoriasis. Apremilast is a phosphodiesterase 4 (PDE4) inhibitor that regulates the transduction of intracellular signals, including pro-inflammatory and anti-inflammatory pathways. Because of the favorable safety profile and the oral route of administration, apremilast may represent a promising therapeutic target for moderate-to-severe psoriasis. In this review, we report an updated overview about clinical trials testing apremilast in the treatment of psoriasis and seek to provide comprehensive information about this anti-psoriatic drug and a future perspective of the therapeutic algorithm for psoriasis.

Cyclosporine: a novel therapeutic approach for Burning Mouth Syndrome.

BACKGROUND: The aim of this paper was to evaluate the efficacy and safety of topical cyclosporine applied as mouthwash in the treatment of burning mouth syndrome (BMS). METHODS: This was a prospective and pilot study conducted by the Department of Dermatology of the University of Rome Tor Vergata. Patients were treated with cyclosporine topically applied as mouthwash for 4 weeks. Clinical improvement was assessed using a 5 grade clinical evaluation scale and a visual analogue scale from 0 to 10 was also used to evaluate the burning symptoms. RESULTS: Fifteen patients between 22-85 years (61.1±19.3), 11 female and 4 male, with a mean duration of BMS of 12.5 months, completed the study. Five out of 15 patients presented a marked improvement, 6 patients showed a moderate response, 3 patients had a slight improvement and 1 patient did not show any change. The VAS showed a reduction from 8.7 to 3.5. Adverse events were not reported. CONCLUSIONS: Cyclosporine mouthwash appeared to be safe and beneficial for reducing the burning sensation in patients with BMS representing an alternative therapy in this condition.

Aphthous, celiac disease and other dental disorders in childhood.

BACKGROUND: Oral conditions and dental disorders are frequent in childhood. Recurrent aphthous stomatitis (RAS) is a common inflammatory condition characterized by painful recurrent, single or multiple ulcerations of the oral mucosa induced by genetic and environmental factors. Celiac disease (CD) is a chronic small intestinal immunemediated enteropathy precipitated by exposure to dietary gluten in genetically predisposed individuals pathogenetically related to oral condition. The aim of the study was to evaluate the different prevalence of oral conditions in CD patients compared to a control group. METHODS: From January 2013 to June 2013, 166 patients, between 2 and 17 years of age and of both genders, were examined in order to evaluate the presence and the medical history of oral conditions. Clinical features of patients affected by CD were compared with those of a control group with similar socio-demographic features. RESULTS: We found that the more common lesions in both groups were RAS (69% in CD patients vs. 43% in the control group), followed by dental disorders (76% in CD patients vs. 65% in the control group). Prevalence of RAS between the two groups was significantly different (P<0.0006). Prevalences of caries and dental abnormalities were the same in the two groups (45% vs. 45% and 16% vs. 16% respectively). CONCLUSIONS: In celiac patients there was a significant higher prevalence of RAS compared to a control group. These findings could be possibly associated with common pathogenetic mechanisms.

Apremilast for the treatment of psoriasis.

INTRODUCTION: Psoriasis is a chronic inflammatory skin disease characterized by dysregulation of the immune system and release of pro-inflammatory mediators. Drugs available for psoriasis show some limits as tolerability and route of administration. Apremilast , Otezla®, is an oral small molecule recently approved for the treatment of patients with moderate-to-severe plaque psoriasis. Compared to biologics that target a single cytokine, apremilast, degrading phosphodiesterase 4 (PDE4), interferes with cyclic anti-microbial peptides, which is involved in the transduction of intracellular signals, controlling the balance of pro-inflammatory and anti-inflammatory signals. AREAS COVERED: This review reported the latest data available from Phase I, II and III trials on apremilast for the treatment of plaque psoriasis. A focus on the clinical management of apremilast, safety and clinical efficacy based on two pivotal clinical trials (ESTEEM 1 and ESTEEM 2) currently ongoing was described. A systematic search was conducted using the PubMed Medline database for primary articles. EXPERT OPINION: Apremilast treatment was demonstrated effective and well tolerated in Phase II and III clinical trials. Several drug peculiarities, such as the low frequency of adverse events and the oral route of administration, make apremilast an innovative treatment for moderate-to-severe psoriasis.

Psoriasis Phenotype in Inflammatory Bowel Disease: A Case-Control Prospective Study.

BACKGROUND AND AIMS: Whether inflammatory bowel disease [IBD] is associated with specific psoriasis phenotypes is undefined. In a case-control prospective study, we aimed to assess the severity and phenotype of psoriasis in IBD vs matched non-IBD controls with psoriasis [non-IBD]. METHODS: From 2011 to 2013, dermatological assessment was performed in all IBD patients showing lesions requiring characterisation. In patients with psoriasis, assessment included: presence, characteristics, and severity. Each IBD patient with psoriasis was matched [gender, ethnicity, age ± 5 years] with one non-IBD patient with psoriasis. STATISTICAL ANALYSIS: data were expressed as median [range], chi-square, Student's t test. RESULTS: Dermatological assessment was performed in 251 IBD patients [115 females, age 47 [16-85]; IBD duration 9 years [1-46]]: 158 Crohn's disease [CD] [63%], 93 ulcerative colitis [UC] [37%]. Psoriasis was detected in 62 [25%] IBD patients: 36 [58%] CD, 26 UC [42%; p = 0.44]. Clinical characteristics were comparable between IBD patients with or without psoriasis: age 50 [23-72] vs 47 [16-85]; IBD duration 9.5 [1-46] vs 9 [1-41]; p = non-significant]. The non-IBD group included 62 patients with psoriasis: 35 male; age 47 [18-75]. Mild psoriasis was more frequent in IBD vs non-IBD [87% vs 53%; p < 0.0001], whereas moderate and severe psoriasis were more frequent in non-IBD vs IBD [37% vs 13%, p = 0.004; 10% vs 0%; p = 0.036]. Plaque-type psoriasis was the most common phenotype in both IBD and non-IBD [p < 0.0001 vs others phenotypes].The frequency of plaque-type, nail psoriasis and psoriatic arthritis was lower in IBD vs non-IBD [p = 0.008; p < 0.0001; p = 0.006]. Psoriasis occurred after anti-tumour necrosis factor [TNF]α treatment in six CD patients [7%]. CONCLUSIONS: Severity and phenotypes of psoriasis may differ between patients with IBD and their matched non-IBD controls.

Tofacitinib for the treatment of moderate-to-severe psoriasis.

Because of the increased knowledge about the underlying cytokine network in psoriasis, selective systemic agents for the treatment of moderate-to-severe psoriasis have been developed during the past decade. The marked upregulation of JAK/STAT pathways in psoriasis and the identification of multiple key mediators in psoriasis pathogenesis that signal through JAK/STAT pathways led to investigation of JAK proteins as potential therapeutic targets for psoriasis treatment. A novel JAK-STAT inhibitor, tofacitinib, has been tested in preclinical studies for the treatment of psoriasis. Considering the satisfactory safety profile and the encouraging efficacy observed in the Phase II and Phase III trials, tofacitinib may represent an important therapeutic to be included into the psoriasis paradigm.

Quality of life of psoriatic patients evaluated by a new psychometric assessment tool: PsoDisk.

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.