ImportanceLebrikizumab (LEB), a high-affinity monoclonal antibody targeting interleukin (IL)-13, demonstrated efficacy and safety in patients with moderate-to-severe atopic dermatitis (AD) during 16 weeks of monotherapy in a phase 2b trial, and two 52-week phase 3 trials.ObjectiveTo evaluate efficacy and safety of LEB combined with low- to mid-potency topical corticosteroids (TCS) in patients with moderate-to-severe AD.Design, Setting, and ParticipantsThe ADhere trial was a 16-week randomized, double-blinded, placebo (PBO)-controlled, multicenter, phase 3 clinical trial conducted from February 3, 2020, to September 16, 2021. The study was conducted at 54 outpatient sites across Germany, Poland, Canada, and the US and included adolescent (aged ≥12 to <18 years weighing ≥40 kg) and adult patients with moderate-to-severe AD. The treatment allocation ratio was 2:1 (LEB:PBO).InterventionsOverall, 211 patients were randomized to subcutaneous LEB (loading dose of 500 mg at baseline and week 2, followed by 250 mg every 2 weeks [Q2W] thereafter) or PBO Q2W in combination with TCS for 16 weeks.Main Outcomes and MeasuresEfficacy analyses at week 16 included proportions of patients achieving Investigator’s Global Assessment score of 0 or 1 (IGA [0,1]) with 2 or more points improvement from baseline, and 75% improvement in the Eczema Area and Severity Index (EASI-75). Key secondary end points included evaluation of itch, itch interference on sleep, and quality of life. Safety assessments included monitoring adverse events (AEs).ResultsThe mean (SD) age of patients was 37.2 (19.3) years, 103 (48.8%) patients were women, 31 (14.7%) patients were Asian, and 28 (13.3%) patients were Black/African American. At week 16, IGA (0,1) was achieved by 145 (41.2%) patients in the LEB+TCS group vs 66 (22.1%) receiving PBO+TCS (P = .01); corresponding proportions of patients achieving EASI-75 were 69.5% vs 42.2% (P < .001). The LEB+TCS group showed statistically significant improvements in all key secondary end points. Most treatment-emergent adverse events (TEAEs) were nonserious, mild or moderate in severity, and did not lead to study discontinuation. The TEAEs frequently reported in the LEB+TCS group included conjunctivitis (7 [4.8%]), headache (7 [4.8%]), hypertension (4 [2.8%]), injection site reactions (4 [2.8%]), and herpes infection (5 [3.4%]) vs 1.5% or less patient-reported frequencies in the PBO+TCS group. Similar frequencies of patient-reported serious AEs following LEB+TCS (n = 2, 1.4%) and PBO+TCS (n = 1, 1.5%).Conclusions and RelevanceIn this randomized phase 3 clinical trial, LEB+TCS was associated with improved outcomes in adolescents and adults with moderate-to-severe AD compared with TCS alone, and safety was consistent with previously reported AD trials.Trial RegistrationClinicalTrials.gov Identifier: NCT04250337

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The present multi-center, long-term, real-life study made an attempt to assess the efficacy of risankizumab in the treatment of moderate-to-severe plaque psoriasis. The study comprised 185 patients from 10 Polish dermatologic departments undergoing risankizumab treatment. The disease severity was measured using the Psoriasis Area and Severity Index (PASI) before the start of the risankizumab treatment and next at the defined timepoints, i.e., 4, 16, 28, 40, 52 and 96 weeks of treatment. The percentage of patients achieving PASI90 and PASI100 responses as well as the PASI percentage decrease at the defined timepoints were calculated, and correlations with clinical characteristics and therapeutic effect were analyzed. The number of patients evaluated at the defined timepoints was: 136, 145, 100, 93, 62, and 22 at 4, 16, 28, 40, 52 and 96 weeks of treatment, respectively. At 4, 16, 28, 40, 52 and 96 weeks, the PASI90 response was achieved in 13.2%, 81.4%, 87.0%, 86.0%, 88.7% and 81.8% of patients, whereas the PASI100 response was achieved in 2.9%, 53.1%, 67.0%, 68.8%, 71.0% and 68.2% of patients, respectively. Our study revealed a significant negative correlation between a decrease in the PASI and the presence of psoriatic arthritis as well as the patient’s age and duration of psoriasis at several timepoints throughout the observation period.

Przegląd Dermatologiczny 2015/1 StreSzczenieWprowadzenie. Podczas kwalifikowania chorych do programu "Leczenie ciężkiej postaci łuszczycy plackowatej" należy wykonać szereg badań. Nieprawidłowe wyniki wymagają poszerzenia diagnostyki i bardzo często wdrożenia odpowiedniego leczenia. Fałszywie dodatnie wyniki testów laboratoryjnych wpływają na wydłużenie procesu kwalifikacyjnego i często wykluczenie z programu lekowego. Cel pracy. Zwrócenie uwagi na potrzebę zachowania czujności podczas wykonywania badań przy kwalifikowaniu chorych do leczenia w ramach programu lekowego. Opis przypadków. U 45-letniego mężczyzny podczas kwalifikacji do leczenia biologicznego wykonano badanie przesiewowe w kierunku boreliozy. Uzyskano wynik dodatni, ale po jego zweryfikowaniu metodą Western Blot, otrzymano wynik negatywny. Badania znacznie wydłużyły kwalifikację. Podczas kwalifikowania 26-letniego pacjenta do leczenia biologicznego wykonano test QuantiFERON i otrzymano wynik dodatni. Test powtórzono w innym laboratorium, gdzie uzyskano wynik ujemny. Wnioski. Fałszywie dodatnie wyniki badań mogą skutkować pochopnym wykluczeniem z leczenia. Wymiana doświadczeń między lekarzami jest istotna w doskonaleniu kryteriów włączenia chorych do terapii biologicznej. AbStrActIntroduction. Qualification of patients for the therapeutic program of severe plaque psoriasis should be preceded by many tests. Abnormal test results require further evaluation and possibly implementation of treatment. False positive results lead to prolongation of the qualification process and may cause disqualification of the patient. Objective. To draw attention to qualification to a drug program. Case reports. A screening test for Lyme disease performed in a 45-year--old man, during qualification for biological treatment, was positive, but verification by Western blot showed a negative result. It caused significant prolongation of the qualification process. In a 26-year-old

Przegląd Dermatologiczny 2015/3 233 StreSzczenie Wprowadzenie. Rogowiec dłoni i stóp należy do grupy schorzeń, któ-rych istotą jest przewlekłe zaburzenie rogowacenia naskórka. Cel pracy. Przedstawienie przypadku 54-letniej kobiety z ciężką postacią dziedzicznego, punktowego rogowca dłoni i stóp. Opis przypadku. Chora została przyjęta na Oddział Dermatologii Szpitala Copernicus Podmiot Lecznicy Sp. z o.o. z powodu hiperkeratotycznych mas rogowych zajmujących skórę dłoni i stóp i utrudniających poruszanie się. U chorej nie wykryto współistnienia chorób nowotworowych oraz zaburzeń struktury włosów i paznokci. Zmiany o podobnej morfologii stwierdzono u licznych członków rodziny kobiety. Na Oddziale Dermatologii zastosowano intensywne leczenie miejscowe oraz terapię doustną retinoidami, dzięki czemu uzyskano częściową poprawę stanu miejscowego. Wnioski. Wrodzony, dziedziczny rogowiec punktowy dłoni i stóp jest rzadką dermatozą o ciężkim i przewlekłym charakterze. Jej wieloletni przebieg oraz trudności terapeutyczne znacznie wpływają na obniżenie jakości życia chorych. AbStrActIntroduction. Keratoderma of the hands and feet is a chronic disorder of epidermal keratinization, which consists of many various forms. Objective. To present a case of a 54-year-old woman with severe hereditary punctate palmoplantar keratoderma. Case report. The patient was admitted to the Department of Dermatology in Copernicus Hospital because of hyperkeratotic lesions on the hands and feet, with restriction of individual mobility. No coexisting malignancies or nail and hair disorders were diagnosed. Similar changes were found in many members of her family. Intensive topical treatment and oral therapy with retinoids were applied, resulting in a partial improvement. Conclusions. Hereditary punctate palmoplantar keratoderma is a rare disorder. Its long-term course and therapeutic difficulties significantly affect the quality of life. ciężka postać dziedzicznego punktowego rogowca dłoni i stóp (brauer-buschke-Fischer) Severe hereditary punctate palmoplantar keratoderma (brauer-buschke-Fischer syndrome)