Diamant Thaci

• Professor
• University of Lübeck

Tuberculosis (TB), caused by Mycobacterium tuberculosis, is a significant global health problem. In immunocompetent individuals, the microorganism can remain in a latent, non‐contagious form, however, it may become active under conditions of immunosuppression. Tumour necrosis factor (TNF) inhibitors, which are frequently used for the management of...

Background The anti-interleukin-23 antibody guselkumab demonstrated favourable Week 24 efficacy and safety over fumaric acid esters (FAE) in systemic-treatment naïve patients with moderate-to-severe plaque psoriasis (study part I). Objectives Part II: compare a) sustainability of treatment responses (Weeks 24–32) in guselkumab- and FAE-treated pat...

Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the US, EU, and other countries for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. Deucravacitinib treatment was superior to placebo and apremilast in the POETYK PSO-1 (NCT03624127) and...

Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the US, EU, and other countries for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. Deucravacitinib was superior to placebo and apremilast in the POETYK PSO-1 (NCT03624127) and PSO-2 (NC...

Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor for moderate-to-severe plaque psoriasis, was superior to placebo and apremilast in two global, 52-week, phase 3 trials and maintained long-term efficacy through 2 years with no new safety signals in an ongoing long-term extension (LTE) trial. We report clinica...

Introduction: Tyrosine kinase 2 (TYK2) is an intracellular enzyme that mediates signaling of cytokines (eg, interleukin-23, Type I interferons) involved in psoriasis pathogenesis. Deucravacitinib, an oral, selective, allosteric TYK2 inhibitor, is approved in the US, EU, and other countries for the treatment of adults with moderate-to-severe plaque...

Background Patients with psoriasis require long-term management; therefore, understanding the long-term safety of new treatments, such as bimekizumab, is crucial. Objectives To evaluate bimekizumab’s 3-year safety profile in patients with moderate to severe plaque psoriasis. Methods Three years of safety data were pooled from three phase 3 trials...

Introduction. Despite the availability of effective biologic therapies for psoriasis, there is no gold-standard treatment for nonpustular palmoplantar psoriasis (ppPsO). Methods. G-PLUS, a phase IIIb, double-blind, placebo-controlled, multicentre clinical trial, randomised adults with moderate-to-severe nonpustular ppPsO and limited plaque psoriasi...

The benefit/risk profiles of biologics can be affected by comorbidities, certain demographic characteristics, and concomitant medications; therefore, it is important to evaluate the long-term safety profiles of biologics across broad patient populations. Guselkumab was well tolerated and efficacious across individual pivotal clinical studies in adu...

Detlef Zillikens, MD, director and chair of the Department of Dermatology at the University of Lübeck, Lübeck, Germany, died in September 2022, aged only 64. He dedicated his professional life to autoimmune blistering diseases (AIBDs) and built his department into one of the world’s leading centers for these diseases. Herein, his professional life...

Background Cancer risk after long‐term exposure to interleukin (IL)‐23 inhibitors (IL‐23i) and IL‐17 inhibitors (IL‐17i) remains to be delineated. Objective To evaluate the risk of malignancies in patients with psoriasis treated with IL‐23i and IL‐17i relative to those prescribed tumour necrosis factor inhibitors (TNFi) during the first 5 years fo...

Comprehensive analysis of tryptophan metabolism across 13 chronic inflammatory diseases.

Chronic inflammatory diseases (CID) are systems disorders affecting various organs including the intestine, joint and skin. The essential amino acid tryptophan (Trp) is not only used for protein synthesis but can also be catabolized to various bioactive derivatives that are important for cellular energy metabolism and immune regulation. Increased T...

Background: Numerous biologic drugs, including etanercept and adalimumab, are administered subcutaneously. This study reviewed the evidence on the usability and preference of self-injection devices of SB4 and SB5 compared with the reference product injectors. Methods: A systematic search was conducted in PubMed using the search string "(Imraldi...

Background Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by pruritic eczematous lesions. The effect of treatment withdrawal after response to upadacitinib oral treatment is not fully characterized. Objectives Assess the effect of upadacitinib withdrawal on skin clearance and itch improvement in adult patients with mod...

Background The risk of infections among patients with psoriasis undergoing interleukin (IL)‐23 inhibitors (IL‐23i) and IL‐17 inhibitors (IL‐17i) is yet to be exhaustively determined. Objective To assess the risk of infectious complications in patients with psoriasis managed by IL‐23i and IL‐17i with tumour necrosis factor inhibitors (TNFi) as a co...

Background: Merkel cell carcinoma (MCC) is an immunogenic but aggressive skin cancer. Even after complete resection and radiation, relapse rates are high. PD-1 and PD-L1 checkpoint inhibitors showed clinical benefit in advanced MCC. We aimed to assess efficacy and safety of adjuvant immune checkpoint inhibition in completely resected MCC (ie, a se...

In the literature there is no consensus on the correlation between early systemic intervention and better treatment response in psoriasis. Here we present data on the impact of disease duration (<5 years, 5‐<10 years, and ≥10 years) on response to tildrakizumab treatment among patients with moderate‐to‐severe plaque psoriasis from the reSURFACE 1 a...

Lebrikizumab (LEB) is a high-affinity monoclonal antibody targeting interleukin (IL)-13, preventing IL-13 signalling via the IL-4Rα/IL-13Rα1 receptor complex. Here, we report 16-week efficacy and safety outcomes of LEB monotherapy in patients with moderate-to-severe atopic dermatitis from two 52-week, randomized, double-blinded, placebo-controlled...

Deucravacitinib, an oral selective allosteric tyrosine kinase 2 inhibitor, is approved in the USA and several other countries and is under review by the European Medicines Agency and other health authorities, for the treatment of moderate-to-severe plaque psoriasis. The efficacy and safety results for deucravacitinib in the phase III, 52-week, doub...

Background Five-year tildrakizumab safety data have been reported as exposure-adjusted incidence rates (EAIRs) of patients with events per 100 patient-years (PYs) of exposure. Objectives To present 5-year safety data from reSURFACE 1/2 phase 3 trials as EAIRs of events per 100 PYs of exposure, and the number needed to harm (NNH) for one adverse ev...

Tralokinumab is a high-affinity, fully human IgG4 monoclonal antibody that specifically inhibits interleukin-13 (IL-13), a key driver of atopic dermatitis (AD) disease progression. Clinical trials have shown that tralokinumab is efficacious in patients with moderate-to-severe AD and has a favorable safety profile, including a low frequency of adver...

Lebrikizumab (LEB) is a monoclonal antibody that binds with high affinity to interleukin (IL)-13, thereby blocking the downstream effects of IL-13 with high potency. To report integrated safety information in adult and adolescent patients with moderate-to-severe atopic dermatitis treated with LEB, from an integrated safety analysis of eight clinica...

Background: In ANCA-associated vasculitis (AAV), the use of rituximab (RTX) according to the RAVE trial [1] or RTX in combination with cyclophosphamide (CYC) according to the RITUXVAS trial [2] showed noninferiority to CYC for the induction of remission. However, there is a lack of comparative real-world data between both therapy regimens. Objectiv...

Background: Autoimmune skin diseases can expedite various systemic sequelae involving other organs. Although limited to the skin, cutaneous lupus erythematosus (CLE) was noted to be associated with thromboembolic diseases. However, small cohort sizes, partially discrepant outcomes, missing data on CLE subtypes, and incomplete risk assessment limit...

Background Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects the skin, nails, tendons and joints. In addition, several comorbidities have been identified with PsA. In particular, a frequent occurrence of fatigue and mental disorders such as depression have been described in patients with PsA. Key cellular players in pathophys...

Background Tyrosine kinase 2 (TYK2) is an intracellular enzyme involved in IL-23 signaling that is important in the pathogenesis of immune-mediated diseases, including psoriasis, psoriatic arthritis, and systemic lupus erythematosus (SLE). Deucravacitinib is a first-in-class, oral, selective, allosteric TYK2 inhibitor approved in multiple countries...

Background Deucravacitinib is a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor approved in multiple countries for the treatment of adults with plaque psoriasis. Deucravacitinib suppresses signaling of cytokines involved in the pathogenesis of immune-mediated diseases including psoriasis, psoriatic arthritis, and syst...

Background Given the chronic, long-term nature of psoriatic arthritis (PsA), sustaining high levels of disease control with treatment is important. Assessing the maintenance of response in patients (pts) that achieve treatment targets is of interest, particularly as pts can experience loss of response with long-term therapy [1]. Bimekizumab (BKZ),...

Background Atopic dermatitis (AD) is a heterogeneous inflammatory skin disease with different clinical phenotypes based on factors such as age, race, comorbidities, and clinical signs and symptoms. The effect of these factors on therapeutic responses in AD has only been scarcely studied and not for upadacitinib. Currently, there is no biomarker pre...

Background: Traditional systemic immunosuppressants and advanced therapies improve signs and symptoms of moderate-to-severe atopic dermatitis (AD). However, data are limited in severe and/or difficult-to-treat AD. In the phase 3 JADE COMPARE trial of patients with moderate-to-severe AD receiving background topical therapy, once-daily abrocitinib 2...

Background: Lebrikizumab is a monoclonal antibody that binds with high affinity to interleukin (IL)-13, thereby blocking the downstream effects of IL-13 with high potency. Objectives: To report integrated safety of lebrikizumab in adults and adolescents with moderate-to-severe atopic dermatitis from phase 2 and 3 studies. Methods: Five double-...

What is this summary about?: This is a summary of a paper published in a medical journal that describes the results of a study called POETYK PSO-2, which investigated a new treatment for plaque psoriasis. Plaque psoriasis appears on the body as dry, discolored, patches of skin that can be flaky and covered in scales. This can make the skin itch, c...

What is this summary about?: This is a summary of a paper published in a medical journal that describes the results of a study called POETYK PSO-1, which looked at a new treatment called deucravacitinib for plaque psoriasis. Plaque psoriasis appears on the body as round or oval raised patches (called plaques) typically covered by scales. This can...

Effisayil 1 was a multicentre, randomized, double‐blind, placebo‐controlled study of the anti‐interleukin (IL)‐36 receptor monoclonal antibody, spesolimab, in patients presenting with a generalized pustular psoriasis (GPP) flare. Previously published data from this study revealed that within 1 week, rapid pustular and skin clearance were observed i...

Background: Bimekizumab is a monoclonal IgG1 antibody that inhibits interleukin (IL)-17A/F. Bimekizumab is more efficacious than secukinumab over one year in the treatment of psoriasis. Objective: Evaluate safety and efficacy of bimekizumab through two years in patients with moderate to severe plaque psoriasis. Methods: The BE RADIANT phase 3b...

Background Moderate to severe AD can be successfully managed by systemic treatments. Current guidelines also recommend emollients or emollients ‘plus’ and eudermic cleansers for all AD patients to improve the skin barrier and provide anti‐irritant and anti‐pruritic effects. Objectives To investigate the efficacy of skin care (in addition to system...

Background: Guselkumab has demonstrated favourable safety and efficacy across individual clinical studies in adults with moderate-to-severe plaque psoriasis. Objectives: Evaluate guselkumab safety in patients with psoriasis using pooled data from seven Phase 2/3 studies (X-PLORE, VOYAGE 1, VOYAGE 2, NAVIGATE, ORION, ECLIPSE, Japan registration)....

Background: Malignancy risk surveillance among patients receiving long-term immunomodulatory psoriasis treatments remains an important safety objective. Objective: To report malignancy rates in patients with moderate-to-severe psoriasis treated with guselkumab for up to 5 years vs. general and psoriasis patient populations. Methods: Cumulative...

Dupilumab was first approved for the treatment of atopic dermatitis (AD) and blocks the signaling of interleukin (IL)-4 and -13. Several other chronic skin conditions share mechanistic overlaps with AD in their pathophysiology, i.e., are linked to type 2 inflammation. Most recently, dupilumab was approved by the U.S. Food and Drug Administration fo...

The VOYAGE 1 and 2 studies of guselkumab in moderate-to-severe psoriasis are among the first studies of biologics to include patients with a history of malignancy. In these studies, 18 guselkumab-treated patients had a history of malignancy (excluding nonmelanoma skin cancer) >5 years prior to enrolment. These 18 patients were exposed to guselkumab...

Background: Lebrikizumab, a high-affinity IgG4 monoclonal antibody targeting interleukin-13, prevents the formation of the interleukin-4Rα-interleukin-13Rα1 heterodimer receptor signaling complex. Methods: We conducted two identically designed, 52-week, randomized, double-blind, placebo-controlled, phase 3 trials; both trials included a 16-week...

Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved by the US Food and Drug Administration for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. In the phase 3 POETYK PSO-1 and PSO-2 trials, deucravacitinib was significantly mo...

Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved by the US FDA for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Deucravacitinib was significantly more efficacious than placebo or apremilast and was well tolerated in pre...

Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved by the US Food and Drug Administration for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. In the pivotal phase 3 POETYK PSO-1 trial, deucravacitinib was superior to placebo...

Lichen sclerosus (LS) is an underdiagnosed inflammatory mucocutaneous condition affecting the anogenital areas. Postmenopausal women are predominantly affected and, to a lesser extent, men, prepubertal children, and adolescents. The etiology of LS is still unknown. Hormonal status, frequent trauma and autoimmune diseases are well-known associations...

Introduction: Dupilumab has significantly improved the signs, symptoms and quality of life (QoL) of patients with moderate-to-severe atopic dermatitis (AD) in randomised, controlled clinical trials. However, there is a need to assess the effectiveness and safety of dupilumab in real-world clinical practice. The PROLEAD study was designed to examin...

Background: Psoriasis is a chronic inflammatory skin disorder that affects 125 million people worldwide, with one-third having childhood onset. Objectives: The PURPOSE study evaluated long-term safety and effectiveness of etanercept in paediatric psoriasis. Materials & methods: This observational study enrolled patients with paediatric psorias...

Background Baricitinib, a selective Janus kinase (JAK)1/JAK2 inhibitor, is approved for treatment of moderate-to-severe atopic dermatitis (AD) in adults. Objectives We report integrated baricitinib safety data in patients with up to 3.9-years exposure. Methods Three datasets from the integrated AD clinical trial program were analyzed: placebo-con...

Patients with active nonsegmental vitiligo (NSV) may experience active lesions (confetti-like and trichrome lesions) or stable lesions (where lesions may remain unchanged for ∼1 year or more). In a phase 2b trial, the oral JAK3/TEC inhibitor ritlecitinib demonstrated a significant improvement in the Facial-Vitiligo Area Scoring Index at Week 24 for...

Despite the emergence of novel targeted treatments for atopic dermatitis (AD), there is a lack of guidelines on standardizing analysis of clinical trial data. To define and estimate meaningful treatment comparisons, several factors, including intercurrent events, must be taken into account. Intercurrent events are defined as events occurring after...

Zusammenfassung Hintergrund Chronische Entzündungserkrankungen (engl. „immune-mediated inflammatory diseases“ [IMID]) sind mit einer erheblichen Krankheitslast verbunden. Diese ist umso ausgeprägter, sofern diese gleichzeitig bei Patienten auftreten oder z. B. weitere Komorbiditäten bestehen. Die Versorgung der IMID ist komplex und involviert dive...

Background The role of methotrexate in combination with biological agents in patients with psoriatic arthritis remains unclear. The MUST phase 3b trial aimed to compare the efficacy of ustekinumab plus placebo with ustekinumab plus methotrexate in patients with active psoriatic arthritis. Methods In this investigator-initiated, randomised, multicen...

Background The German government implemented the Digital Healthcare Act in order to bring Digital Therapeutics into standard medical care. This is one of the first regulatory pathways to reimbursement for Digital Therapeutics (DTx). The Digital Therapeutic sinCephalea is intended to act as a prophylactic treatment of migraine by reducing the migrai...

Psoriasis is not optimally controlled in spite of newly developed treatments, possibly due to the difficulty of objectively quantifying the disease’s severity, considering the limitations of the clinical scores used in clinical practice. A major challenge addresses difficult-to-treat areas, especially in the absence of significant body surface invo...

Interleukin 17C (IL-17C) modulates epithelial inflammation and has a possible role in atopic dermatitis (AD) pathology. Four randomized clinical studies (Phase 1 and 2) investigated the safety, tolerability, efficacy, and pharmacokinetic profile of the anti-IL-17C monoclonal antibody MOR106 for up to 12 weeks (NCT03568071: n = 207 adults with moder...

Background Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F and IL-17A. This study compared the efficacy and safety of bimekizumab with placebo over 16 weeks in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α (TNFα) inhibitors. Methods BE CO...

Background Vitiligo is a chronic autoimmune disorder characterized by depigmented patches of the skin. Objective To evaluate the efficacy and safety of ritlecitinib, an oral JAK3/TEC inhibitor, in patients with active nonsegmental vitiligo (NSV) in a phase 2b trial (NCT03715829). Methods Patients were randomized to once-daily oral ritlecitinib ±...