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Summary: Chronic urticaria (CU) affects about 1% of the world population of all ages, mostly young and middle‐aged women. It usually lasts for several years (> 1 year in 25–75% of patients) and often takes > 1 year before effective management is implemented. It presents as chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU) or both in the same person. More than 25% of cases are resistant to H1‐antihistamines, even at higher doses, and third‐ and fourth‐line therapies (omalizumab and ciclosporin) control the disease only in two‐thirds of H1‐antihistamine‐resistant patients. Here we review the impact of CU on different aspects of patients' quality of life and the burden of this chronic disease for the patient and society. CU may have a strong impact on health‐related quality of life (HRQoL), particularly when CSU is associated with angio‐oedema and/or CIndU (Dermatology Life Quality Index > 10 in 30% of patients). Comorbidities, such as anxiety and depression, which are present in more than 30% of patients with CSU, compound HRQoL impairment. Severe pruritus and the unpredictable occurrence of weals and angio‐oedema are responsible for sleep disorders; sexual dysfunction; limitations on daily life, work and sports activities; interfering with life within the family and in society; and patients' performance at school and work (6% absenteeism and 25% presenteeism). Apart from treatment costs, with annual values between 900 and 2400 purchasing power parity dollars (PPP$) in Europe and the USA, CU is associated with a high consumption of medical resources and other indirect costs, which may reach a total annual cost of PPP$ 15 550. Plain language summary available online [ABSTRACT FROM AUTHOR]

Background Cold urticaria is a rare but severe and potentially lethal condition. It is primarily treated symptomatically with H1-antihistamines. However, patients have a variable response to these drugs and, to date, it has not been possible to predict readily the response to therapy of individual patients. Objectives To assess the severity of the cold urticaria in naive patients and the response to therapy of patients treated with increasing doses of an H1-antihistamine by measurement of critical temperature thresholds (CTT) for producing weals on the forearm. Methods This was a two-centre, hospital-based, double-blind, randomized, parallel-group study of patients with a confirmed diagnosis of cold urticaria of at least 6 months' duration. Patient groups received either a constant dose of desloratadine 5 mg daily for 6 weeks ( n = 13), or escalating doses of desloratadine: 5 mg daily for the first 2 weeks, 10 mg daily for the second 2 weeks and 20 mg daily for the final 2 weeks ( n = 15). Only one adverse event that appeared to be drug related was reported: mild fatigue after treatment with desloratadine 10 mg that lasted for about 3 weeks and resolved at the end of the study. Results The desloratadine 5 mg daily dose produced a submaximal reduction of mean CTT which remained relatively constant over 6 weeks. Dose escalation increased efficacy, the reduction in mean CTT at four-times the standard daily dose being significantly greater ( P = 0·03) than with the standard dose. Individually, no patient became symptom free (CTT < 4 °C) on 5 mg, while two became symptom free on 10 mg and a further three on 20 mg desloratadine daily. Conclusions Measurement of CTT allows for individualized risk management and therapy in patients with cold urticaria. [ABSTRACT FROM AUTHOR]

Background: Monoclonal antibodies to interleukin (IL)-17 have shown strong efficacy in patients with psoriasis. Izokibep is a unique IL-17A inhibitor with a small molecular size and favourable distribution to sites of inflammation., Objectives: To evaluate the dose response, efficacy and safety of izokibep in patients with plaque psoriasis., Methods: In this double-blind, randomized, phase II dose-finding study (AFFIRM-35) in adults with moderate-to-severe plaque psoriasis and inadequate response to two or more standard therapies, patients were randomized (1:1:1:1:1) to placebo or izokibep 2, 20, 80 or 160 mg every 2 weeks for 12 weeks. During the remainder of the 52-week core study, patients given placebo were switched to izokibep 80 mg, and dosing intervals were adapted based on Psoriasis Area and Severity Index (PASI) scores for all patients. The core study was followed by two optional consecutive 1-year extension periods for a total duration of 3 years. The primary endpoint was a 90% reduction in PASI score (PASI 90) at week 12. Additional efficacy outcomes and adverse event (AE) rates were evaluated., Results: In total, 109 patients were randomized [safety set, n = 108 (one exclusion criteria failure); full analysis set, n = 106]. At week 12, PASI 90 response rates were 0%, 5%, 19%, 71% and 59% for the placebo, 2-, 20-, 80- and 160-mg izokibep groups, respectively. Rapid dose-dependent improvements were also observed across other efficacy outcomes. During the placebo-controlled period, AEs in the izokibep groups were similar to placebo except for mild injection site reactions. AEs were generally mild to moderate and the drug was well tolerated. Izokibep maintained efficacy at the higher dosage groups for up to 3 years, with no new safety signals., Conclusions: Data from this phase II study indicate that izokibep is well tolerated and efficacious in the treatment of plaque psoriasis. Higher doses or more frequent dosing could be explored to further enhance response rates., Competing Interests: Conflicts of interest: S.G. has received grants, contracts, honoraria, support for meetings/travel and/or participated in advisory or data safety monitoring boards for AbbVie, ACELYRIN, Affibody, Akari Therapeutics, Almirall-Hermal, Amgen, argenx, Aristea Therapeutics, Biogen Idec, Bioskin, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Dermira, Eli Lilly, Galderma, Hexal, Incyte, Janssen-Cilag, Johnson & Johnson, Klinge Pharma, Kymab, LEO Pharma, Medac, MSD, Neubourg Skin Care, Novartis, Pfizer, Pierre Fabre, Principia Biopharma, Regeneron Pharmaceutical, Sandoz Biopharmaceuticals, Sanofi-Aventis, Trevi Therapeutics and UCB Pharma; and has received equipment, materials, drugs, medical writing or other services from AbbVie, Almirall-Hermal, Amgen, Celgene, Eli Lilly, Janssen-Cilag, LEO Pharma, Medac, Novartis, Pfizer, Sanofi-Aventis and UCB Pharma. P.S. has received grants, contracts, honoraria, support for meetings/travel and/or has participated in advisory or data safety monitoring boards for AbbVie, Allergika, Almirall-Hermal, Amgen, Beiersdorf, Biocryst, BMS, Boehringer Ingelheim, Celgene, CSL-Behring, Eli Lilly, Galderma, Hexal, Janssen, Klinge, Klosterfrau, LEO Pharma, LETI Pharma, L’Oréal, Novartis, Octapharma, Pfizer, Pflüger, Pharming, Regeneron, Shire, Takeda, Regeneron, Sanofi-Genzyme und UCB Pharma. D.W. has received consulting fees from Affibody and ACELYRIN. M.A. has received grants, contracts and/or consulting fees from Arbeitsgemeinschaft Dermatologische Prävention (ADP) Education of Referees for certificate “Hautkrebs-Screening” issued by Zentralinstitut für Kassenärztliche Versorgung, Lumenis and various companies involved in laser treatments in dermatology. G.V. has received consulting fees from Affibody. J.F. is an employee of Affibody, owns stock in Affibody and is a patent holder of five patents involving interleukin-17A-binding and albumin-binding polypeptides. L.O.K., S.O. and N.C.B. are employees of Affibody and have stock options for Affibody. P.P. is an employee of ACELYRIN and has stock options for ACELYRIN. F.Y.F. is an employee of Affibody, owns stock in Affibody and has stock options for Affibody. T.D., O.W., J.N., R.d.M, and A.R. declare no conflicts of interest., (© The Author(s) 2023. Published by Oxford University Press on behalf of British Association of Dermatologists.)

Background: Hidradenitis suppurativa (HS) is an inflammatory disease of the inverse skin regions that occurs in young women, in particular, and affects approximately 1% of the population. Outpatient care is often inadequate and usually cannot prevent progression., Objectives: To evaluate in the EsmAiL ('Evaluation eines strukturierten und leitlinienbasierten multmodalen Versorgungskonzepts für Menschen mit Akne inversa') trial whether an innovative care concept can decrease disease activity and burden, and improve patient satisfaction., Methods: EsmAiL was conducted as a two-arm, multicentre, prospective, randomized controlled trial that included 553 adults with HS. Inclusion criteria were a minimum of three inflammatory lesions and at least a moderate impact of the disease on quality of life. The control group (CG) remained under standard care, while patients in the intervention group (IG) were treated according to a trial-specific, multimodal concept. The primary endpoint was the absolute change in International Hidradenitis Suppurativa Severity Score System (IHS4)., Results: In total, 274 patients were randomized to the IG and 279 to the CG. Altogether, 377 attended the final assessment after 12 months of intervention. Participants in the IG (n = 203) achieved a mean improvement in IHS4 of 9.3 points, while the average decrease in IHS4 in patients in the CG (n = 174) was 5.7 points (P = 0.003). Patients treated under the new care concept also reported a statistically significantly higher decrease in pain, Dermatology Life Quality Index and Hospital Anxiety and Depression Scale scores compared with those in the CG (P < 0.001). Patient satisfaction was also statistically significantly higher in the IG compared with the CG (P < 0.001)., Conclusions: The establishment of standardized treatment algorithms in so-called 'acne inversa centres' in the ambulatory setting has a substantial, positive impact on the course of HS and significantly improves patient satisfaction., Competing Interests: Conflicts of interest M.S. reports auditor activity on the implementation of the contract ‘AOK-Priomed Acne inversa’ for LENICURA; the receipt of honoraria for lectures from AbbVie; and the funding of travel, congress and hotel fees from AbbVie and Pfizer. P.S. has received grants or contracts from Novartis and Almirall; consulting fees from AbbVie, Allergika, Almirall-Hermal, Amgen, Beiersdorf, Biocryst, BMS, Boehringer Ingelheim, Celgene, CSL Behring, Eli Lilly, Falk, Galderma, Hexal, Janssen, Klinge, Klosterfrau, LEO Pharma, LETI Pharma, L’Oréal, Novartis, Octapharma, Pfizer, Pflüger, Pharming, Regeneron, Shire, Takeda, Sanofi–Genzyme and UCB Pharma; and has had a leadership or fiduciary role for the Society of dermopharmazie, unrelated to work presented here. G.N. reports consulting fees from Dessau Medical Center, which received a consulting fee from Mölnlycke Health Care GmbH, for which he served as a consulting physician; has received speaker fees for attending the European Academy of Dermatology and Venerology (EADV) hidradenitis suppurativa course held on 28–30 November 2022 in Porto, Portugal; and has received an Eli Lilly scholarship for attending the EADV Congress 2021. F.B. has received consulting fees from AbbVie, Incyte, AbbVie Deutschland, MoonLake, Novartis Pharma, Janssen Cilag and UCB Pharma; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events for AbbVie, Incyte, AbbVie Deutschland, Novartis Pharma, Janssen Cilag and UCB Pharma; support for attending meetings and/or travel from AbbVie, Incyte, AbbVie Deutschland, Novartis Pharma, Janssen Cilag and UCB Pharma; and has participated on a data protection monitoring board or advisory board for AbbVie, Incyte, AbbVie Deutschland, Novartis Pharma, Janssen Cilag, UCB Pharma and Boehringer Ingelheim Pharma. U.K. has received consulting fees from Novartis; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Novartis; has participated on a data protection monitoring board or advisory board for Novartis, EsmAiL and EpiCAi; and has had a leadership or fiduciary role for Deutsche Gesellschaft für Wundheilung und Wundbehandlung. K.H. has patents planned, issued or pending (DE102015000150B4); and has stocks or stock options in LENICURA (CEO and stockholder of the company). M.G. has received grants or contracts for clinical studies on hidradenitis suppurativa as deputy Principal Investigator (PI) sponsored by Novartis, Janssen and UCB, and for clinical studies on pemphigus vulgaris and bullous pemphigoid as PI sponsored by Argenx, and for a clinical study on prurigo nodularis as PI sponsored by Galderma (institutional contract; no personal payment); consulting fees from Almirall (personal payment) and Argenx (payment to institution); payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from GSK, Eli Lilly and Janssen (personal payment); support for attending meetings and/or travel from UCB (travel support); has participated in data protection monitoring or advisory boards for UCB, GSK and LEO (personal payment); and is a member of the Board of Directors and Treasurer of the German Society of Dermatology (‘Deutsche Dermatologische Gesellschaft’), Section Editor of the Journal der Dt. Dermatologischen Gesellschaft and a member of the Board of Directors of the University Hospital Würzburg (all unpaid). S.G. reports grants or contracts from Novartis and Pierre Fabre; consulting fees from AbbVie, BMS, MSD, Genzyme, Klinge Pharma, Sun Pharma, Kyowa-Kirin, Novartis and Pierre Fabre; has participated on a data safety monitoring or advisory board for Alcedis; and is a member of DeCOG (German dermatological cooperative oncology group), unrelated to the work presented herein., (© The Author(s) 2023. Published by Oxford University Press on behalf of British Association of Dermatologists.)