Safety of biologic therapy in combination with methotrexate in moderate to severe psoriasis: a cohort study from the BIOBADADERM registry.

BACKGROUND: Safety is an important consideration in decisions on treatment for patients with moderate-to-severe psoriasis and the study of drug safety is the main purpose of the BIOBADADERM registry. The combination of a biologic agent and a conventional systemic drug [generally methotrexate (MTX)] is a common treatment in clinical practice. However, there is a paucity of evidence from real-world practice on the safety of such combination regimens in the treatment of psoriasis. OBJECTIVES: The primary objective of this study was to ascertain whether the use of regimens combining biologic drugs with MTX in the management of moderate-to-severe psoriasis increases the risk of adverse events (AEs) or serious AEs (SAEs). We compared monotherapy using tumour necrosis factor (TNF), interleukin (IL)-17 and IL-23 inhibitors with the use of the same drugs in combination with MTX. METHODS: Using data from the BIOBADADERM registry, we compared biologic monotherapies with therapies that were combined with MTX. We estimated adjusted incidence rate ratios (aIRR) using a random effects Poisson regression with 95% confidence intervals for all AEs, SAEs, infections and serious infections and other AEs by system organ class. RESULTS: We analysed data from 2829 patients and 5441 treatment cycles, a total of 12 853 patient-years. The combination of a biologic with MTX was not associated with statistically significant increases in overall risk of AEs or SAEs in any treatment group. No increase in the total number of infections or serious infections in patients receiving combined therapy was observed for any group. However, treatment with a TNF inhibitor combined with MTX was associated with an increase in the incidence of gastrointestinal AEs (aIRR 2.50, 95% CI 1.57-3.98; P < 0.002). CONCLUSIONS: The risk of AEs and SAEs was not significantly increased in patients with moderate-to-severe psoriasis receiving different classes of biologic drugs combined with MTX compared with those on biologic monotherapy.

Dermoscopic changes in 22 extrafacial in situ and invasive lentiginous melanomas

Background: Diagnosis of non-facial melanomas on sun-damaged skin or extrafacial lentigo maligna is challenging. Objectives: To identify the evolutionary dermoscopic signs, characteristic of this type of non-facial melanoma on sun-damaged skin. Materials & Methods: This retrospective descriptive observational study included 90 dermoscopic follow-up images of 22 non-facial melanomas on sun-damaged skin from 17 high-risk melanoma patients, followed with digital dermoscopy and diagnosed between January 2016 and October 2020. We recorded dermoscopic changes by comparing each dermoscopic image with the previous one (mean dermoscopic follow-up of the excised lesions was 3.6 years). Confocal microscopy images were taken at diagnosis. Results: In total, 51.5% (95% CI: 39-64) showed an appearance or increase in featureless areas with surrounding small round or triangular dark brown-blue structures, 23% (95% CI: 23-46) showed an increase in other geometric structures (angulated lines, zig-zag lines and polycyclic structures), 5.9% (95% CI: 2-14) showed an appearance or increase in bright white lines and atypical vascularization, 26.5% (95% CI: 17-39) showed an appearance or increase in follicular pigmentation structures or follicular radial lines, and 39.7% (95% CI: 28-52) showed focal islands of pigmentation in these areas. Of the changes, 54% occurred at the last and diagnostic visit. There was an increase in size in only 20.6% (95% CI: 12-32). Also, 81.8% showed pagetoid cells in the epidermis, 95.5% atypical cells at the dermoepidermal junction by reflectance confocal microscopy, and 95.5% showed non-edged or edged and non-edged papillae. Conclusion: This study identifies the dermoscopic evolutionary changes associated with extrafacial lentigo maligna.

Guselkumab effectiveness and survival in patients with psoriasis and psoriatic arthritis: Multicenter analysis in daily clinical practice by the Spanish Psoriasis Group.

Guselkumab is a monoclonal antibody that selectively blocks the p19 subunit of interleukin 23 and has been approved for the treatment of moderate to severe psoriasis and active psoriatic arthritis in adult patients due to its efficacy in different clinical trials. Therefore, itis important to know the performance of guselkumab in this setting of patients in clinical practice given that a high percentage of them are not represented in these clinical trials. Our objective was to evaluate the effectiveness and tolerability of guselkumab in clinical practice in the first patients with psoriasis and psoriatic arthritis treated since the date of its approval for psoriasis in Spain, in joint dermatology-rheumatology clinics. A multicenter retrospective data collection was carried out, in which 14 hospitals participated, including a total of 90 patients with psoriatic arthritis confirmed by a rheumatologist. Data collection was recorded at baseline and at weeks 12, 24, and 52 for both the articular and cutaneous domains. Ninety PsA patients started treatment with guselkumab and therefore were included in this study. The vast majority had already failed to at least to one biologic therapyprior guselkumab prescription. The median age was 55 years, 61% were female and 46% had a BMI ≥ 30 kg/m2 . Sixty-nine percent suffered from peripheral arthritis, and in 34% an axial involvement was also detected; dactylitis or enthesitis was present in 24% and 29% of patients, respectively. Guselkumab was effective in controlling both articular and skin manifestations of PsA patients. Absolute PASI significantly decreased from 10.5 to 4.8, 1.9 and 1.3 at weeks 12, 24, and 52, respectively. In 29 out of 61 (48%) of cases, DAPSA was moderate or high, and patients showed a significant reduction in DAPSA at 12, 24, and 52 weeks of treatment (mean DAPSA values at baseline and follow up were 29, 20, 16, and 14, respectively). Patients with DAPSA in low activity or in remission at the time of initiation of guselkumab maintained response at the end of the study period. No new safety concerns were detected. Seventy-eight out of 90 patients (84.4%) persisted on treatment after 2 years follow-up. Our experience suggests that guselkumab isan effective drug for PsA and PsO patients in clinical practice with good tolerability and no additional safety signals, making it a new therapeutic alternative for the treatment of PsA and PsO patients.

The Synergy between Pharmacological Regimens and Dermocosmetics and Its Impact on Adherence in Acne Treatment.

Background: Acne is the most common inflammatory skin disease in adolescence. It is also prevalent in adults, especially females. The disease has a considerable impact on health-related quality of life. Many studies have reported the negative impact of acne on patients due to skin disfigurement, ineffective treatment, and adverse effects of the treatment. Numerous factors contribute towards nonadherence to therapy. Summary. This review discusses the various factors that are related to treatment nonadherence such as ineffective therapy, adverse effects with topical pharmacotherapy such as skin irritation and erythema as well as patient-related factors such as lack of knowledge of disease and a poor patient-physician relationship. Various methods are being adopted to increase adherence to treatments. Increased adherence to acne therapy has been associated with the use of dermocosmetics, such as moisturizers and cleansers. Encouraging the use of dermocosmetics in synergy with pharmacological regimens could support improved treatment adherence resulting in better clinical outcomes for acne patients. Conclusion: Dermocosmetics as an adjunct to pharmacological regimens has the potential to improve clinical outcomes by increasing treatment adherence in patients with acne.

Monkeypox: a new differential diagnosis when addressing genital ulcer disease.

We describe a case of genital ulcer and inguinal adenopathies that were attributable to monkeypox virus infection. We suggest clinicians adopt a low threshold for suspicion, particularly when evaluating genital ulcer disease.

Complications Associated with Mohs Micrographic Surgery: Data from the Nationwide Prospective Cohort REGESMOHS.

BACKGROUND: Large prospective studies on the safety of Mohs micrographic (MMS) surgery are scarce, and most focus on a single type of surgical adverse event. Mid-term scar alterations and functional loss have not been described. OBJECTIVES: To describe the risk of MMS complications and the risk factors for them. METHODS: A nationwide prospective cohort collected all adverse events on consecutive patients in 22 specialised centres. We used multilevel mixed-effects logistic regression to find out factors associated with adverse events. RESULTS: 5,017 patients were included, with 14,421 patient-years of follow-up. 7.0% had some perioperative morbidity and 6.5% had mid-term and scar-related complications. The overall risk of complications was mainly associated with use of antiaggregant/anticoagulant and larger tumours, affecting deeper structures, not reaching a tumour-free border, and requiring complex repair. Age and outpatient setting were not linked to the incidence of adverse events. Risk factors for haemorrhage (0.9%) were therapy with antiaggregant/anticoagulants, tumour size, duration of surgery, and unfinished surgery. Wound necrosis (1.9%) and dehiscence (1.0%) were associated with larger defects and complex closures. Immunosuppression was only associated with an increased risk of necrosis. Surgeries reaching deeper structures, larger tumours and previous surgical treatments were associated with wound infection (0.9%). Aesthetic scar alterations (5.4%) were more common in younger patients, with larger tumours, in H-area, and in flap and complex closures. Risk factors for functional scar alterations (1.7%) were the need for general anaesthesia, larger tumours that had received previous surgery, and flaps or complex closures. CONCLUSIONS: MMS shows a low risk of complications. Most of the risk factors for complications were related to tumour size and depth, and the resulting need for complex surgery. Antiaggregant/anticoagulant intake was associated with a small increase in the risk of haemorrhage, that probably does not justify withdrawal. Age and outpatient setting were not linked to the risk of adverse events.

The risk of hepatic adverse events of systemic medications for psoriasis: a prospective cohort study using the BIOBADADERM registry.

BACKGROUND: Limited information is available regarding the risk of incident liver disease in patients with psoriasis receiving systemic therapies. OBJECTIVES: To describe the liver safety findings of conventional and modern systemic therapies for moderate-to-severe psoriasis, and to compare the relative incidence rates of hepatic adverse events (AEs) for each drug. METHODS: All the patients on the BIOBADADERM registry were included. Crude and adjusted incidence rate ratios (cIRR and aIRR, respectively) of hepatic AEs, using anti-TNF drugs as reference, were determined. Outcomes of interest were hypertransaminasemia, nonalcoholic fatty liver disease (NADFLD) and a group of other, less represented, hepatic AEs. RESULTS: Our study included 3,171 patients exposed to systemic drugs (6279 treatment cycles). Incident hypertransaminasemia was the most frequent hepatic AE (incidence rate of 21 per 1000 patients-years [CI 95% 18-23]), followed by NAFLD (8 cases per 1000 patients-years [95% CI 6-10]). Methotrexate (aIRR 3.06 [2.31-4.4]; p = 0.000) and cyclosporine (aIRR 2.37 [1.05-5.35]; p = .0378) were associated with an increased risk for hypertransaminasemia when compared to anti-TNF-α agents. No differences were observed between different groups of biologics. Conventional therapies were not associated with new incident NAFLD. CONCLUSIONS: Comparative information of the incidence of hepatic AEs could facilitate drug selection in moderate-to-severe psoriasis.

International registry of dermatological manifestations secondary to COVID-19 infection in 347 Hispanic patients from 25 countries.

BACKGROUND: The infection by coronavirus disease 2019 (COVID-19) has been associated with multiple cutaneous manifestations, although characterization of them in Hispanic patients with darker skin phototypes is lacking. The objective of this study is to characterize the clinical dermatological manifestations associated with COVID-19 infection in cases with few or without general symptoms in patients from Latin America. METHODS: Cross-sectional study using a questionnaire that was made for health professionals (physicians with a specialty in dermatology) to investigate dermatological lesions associated with COVID-19 infection in patients from 25 countries of Latin America. The survey was active from June 9 to July 30, 2020. RESULTS: In this study, information was collected from a total of 347 patients. We found a female gender predominance: 179/347 (51.6%). The mean age at presentation was 40.87 years. The most frequent dermatological manifestations were maculopapular rash and urticarial lesions, followed by papulovesicular lesions, vesicular lesions, chilblain-like lesions, papular lesions, ecchymosis, petechial purpura, pityriasis rosea-like lesions, pruritus, palmoplantar dysesthesias, transient livedo, acral necrosis, palpable purpura, livedo racemosa, and retiform purpura. As far as we know, there are no previous reports of pruritus and palmoplantar dysesthesias. CONCLUSIONS: This registry emphasizes skin manifestations as an important criterion for establishing the diagnosis of COVID-19 infection in Latin American countries. This information will be useful for the early identification of suspected cases by health professionals (dermatologists and nondermatologists) and will allow contact tracing to mitigate the impact on health systems at different levels.

Dermocosmetics: beneficial adjuncts in the treatment of acne vulgaris.

Introduction: Dermocosmetics are increasingly being recognized as an integral part of acne management. Dermocosmetics may minimize the side effects of acne medications, provide synergistic effects by improving the efficacy of other treatments, and limit exposure to environmental factors such as ultraviolet radiation. We aimed to provide an overview of the active ingredients and different types of preparations used in dermocosmetics for acne, and highlight supporting evidence for their use in clinical practice.Methods: A literature search for selected key words was performed using PubMed. Additional papers were identified based on author expertize.Results and discussion: The different types of active ingredients in dermocosmetics for acne can be classified as: sebum-controlling, antimicrobial, anti-inflammatory, anti-oxidant and/or keratolytic. Such agents may modulate the pathogenic pathways in acne. Dermocosmetics can be formulated as emulsions/creams, cleansers or camouflaging make-up. Dermocosmetics are useful treatment adjuncts for acne and have been shown to improve the clinical signs of acne, reduce transepidermal water loss and modify sebum production. Dermocosmetics have also been associated with reducing side effects of pharmacological treatments, high levels of patient satisfaction and increased adherence to treatment regimens. Together this evidence supports the use of dermocosmetics in clinical practice.

Effect of Sex in Systemic Psoriasis Therapy: Differences in Prescription, Effectiveness and Safety in the BIOBADADERM Prospective Cohort.

The effect of sex on systemic therapy for psoriasis has not been well studied. The aim of this study was to analyse a large multicentre Spanish cohort of 2,881 patients with psoriasis (58.3% males), followed from January 2008 to November 2018, to determine whether sex influences prescription, effectiveness of therapy, and the risk of adverse events. The results show that women are more likely than men to be prescribed biologics. There were no differences between men and women in effectiveness of therapy, measured in terms of drug survival. Women were more likely to develop adverse events, but the difference in risk was small and does not justify different management. Study limitations include residual confounding and the use of drug survival as a proxy for effectiveness.

Lengua en pradera segada: una manifestación de la sífilis secundaria / Mowed-meadow pattern of the tongue: A sign of secondary syphilis

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