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1. Early and Sustained Improvements in Symptoms and Quality of Life with Upadacitinib in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: 52-Week Results from Two Phase III Randomized Clinical Trials (Measure Up 1 and Measure Up 2)

Author

Silverberg, Jonathan I., Gooderham, Melinda J., Paller, Amy S., Deleuran, Mette, Bunick, Christopher G., Gold, Linda F. Stein, Hijnen, DirkJan, Calimlim, Brian M., Lee, Wan-Ju, Teixeira, Henrique D., Hu, Xiaofei, Zhang, Shiyu, Yang, Yang, Grada, Ayman, Platt, Andrew M., and Thaçi, Diamant

Published
2024
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5. Efficacy and Safety of Candidate Biosimilar CT-P43 Versus Originator Ustekinumab in Moderate to Severe Plaque Psoriasis: 28-Week Results of a Randomised, Active-Controlled, Double-Blind, Phase III Study

Author

Papp, Kim A., Lebwohl, Mark G., Thaçi, Diamant, Jaworski, Janusz, Kwiek, Bartlomiej, Trefler, Jakub, Dudek, Anna, Szepietowski, Jacek C., Reznichenko, Nataliya, Narbutt, Joanna, Baran, Wojciech, Kolinek, Joanna, Daniluk, Stefan, Bartnicka-Maslowska, Katarzyna, Reich, Adam, Andrashko, Yuriy, Kim, Sunghyun, Bae, Yunju, Jeon, Dabee, Jung, Jinsun, Lee, Hyunseung, Pyo, Tina, and Ko, Woori

Published
2024
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7. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema (DELTA 1 and DELTA 2): results from multicentre, randomised, controlled, double-blind, phase 3 trials

Author

Lynde, Charles, Guenther, Lyn, Sauder, Maxwell, Bissonnette, Robert, Rao, Jaggi, Day, Isaiah, Devani, Alim, Metelitsa, Andrei, Grewal, Parbeer, Molin, Sonja, Ruer-Mulard, Mireille, Giordano-Labadie, Françoise, Maillard, Hervé, Reguiai, Ziad, Bernier, Claire, Leleu, Camille, Seneschal, Julien, Staumont-Sallé, Delphine, Hubiche, Thomas, Jacobzone, Caroline, Khemis, Abdallah, Crépy, Marie-Noëlle, Worm, Margitta, Bauer, Andrea, Sell, Sabine, Ekanayake-Bohlig, Swarna, Pauser, Sylvia, Buhl, Timo, Schwinn, Andreas, Eberlein, Bernadette, Quist, Sven, Bauer, Boris, Peris, Ketty, Rossi, Maria Teresa, Fargnoli, Maria, Naldi, Luigi, Stingeni, Luca, Ferrucci, Silvia, Walecka-Herniczek, Irena, Krasowska, Dorota, Lesiak, Aleksandra, Okuniewska, Aleksandra, Pulka, Grażyna, Dyczek, Malgorzata, Kwiek, Bartlomiej, Czajkowski, Rafal, Myśliwiec, Hanna, Mohandas, Padma, Cliff, Sandeep, Warren, Richard, Cousen, Pippa, Johnston, Graham, Woolf, Richard, Papp, Kim, Adam, David, Toth, Darryl, Hong, Chih-ho, Turchin, Irina, Niakosari, Firouzeh, Poulos, Elena, Rivers, Jason, Ohayon, Jason, Gooderham, Melinda, Tjioe, Milan, Rustemeyer, Thomas, de Bruin-Weller, Marjolein S., Schuttelaar, Marie L.A., Molhoek, Judith, Oosting, Bert, Pinter, Andreas, Kaspari, Markus, Magnolo, Nina, Sebastian, Michael, Thaci, Diamant, Schliemann, Sibylle, Radny, Peter, Leitz, Nicolas, Tsianakas, Athanasios, Yazdi, Amir, Kamstrup, Maria, Sommerlund, Mette, Zachariae, Claus, Owczarek, Witold, Dudra-Jastrzebska, Monika, Reich, Adam, Kowalska-Oledzka, Elzbieta, Szepietowski, Jacek, Poznanska, Maria, Weglowska, Jolanta, Aerts, Olivier, Roquet-Gravy, Pierre-Paul, Lanssens, Sven, Castelijns, Francisca, Scheers, Christelle, Suys, Erwin, Kint, Bernard, Serra-Baldrich, Esther, Carrascosa, José Manuel, de la Cueva Dobao, Pablo, Izu, Rosa, Silvestre, Juan Francisco, Coto-Segura, Pablo, Fernández-Orland, Almudena, Warren, Richard B, Agner, Tove, Schuttelaar, Marie L A, Baranowski, Keith, Korn, Sofie, Kurvits, Merle, Plohberger, Ursula, and Strange Vest, Natacha

Published
2024
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8. Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis (ARCADIA 1 and ARCADIA 2): results from two replicate, double-blind, randomised controlled phase 3 trials

Author

Silverberg, Jonathan I, Wollenberg, Andreas, Reich, Adam, Thaçi, Diamant, Legat, Franz J, Papp, Kim A, Stein Gold, Linda, Bouaziz, Jean-David, Pink, Andrew E, Carrascosa, José Manuel, Rewerska, Barbara, Szepietowski, Jacek C, Krasowska, Dorota, Havlíčková, Blanka, Kalowska, Monika, Magnolo, Nina, Pauser, Sylvia, Nami, Navid, Sauder, Maxwell B, Jain, Vipul, Padlewska, Kamila, Cheong, Soo Yeon, Fleuranceau Morel, Patricia, Ulianov, Liliana, and Piketty, Christophe

Published
2024
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13. Tryptophan degradation as a systems phenomenon in inflammation – an analysis across 13 chronic inflammatory diseases

Author

Harris, Danielle M.M., Szymczak, Silke, Schuchardt, Sven, Labrenz, Johannes, Tran, Florian, Welz, Lina, Graßhoff, Hanna, Zirpel, Henner, Sümbül, Melike, Oumari, Mhmd, Engelbogen, Nils, Junker, Ralf, Conrad, Claudio, Thaçi, Diamant, Frey, Norbert, Franke, Andre, Weidinger, Stephan, Hoyer, Bimba, Rosenstiel, Philip, Waschina, Silvio, Schreiber, Stefan, and Aden, Konrad

Published
2024
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18. Adjuvant immunotherapy with nivolumab versus observation in completely resected Merkel cell carcinoma (ADMEC-O): disease-free survival results from a randomised, open-label, phase 2 trial

Author

van Akkooi, Alexander, van Houdt, Winan, Wilhelm, Tabea, Farmer, Kimberley, Ulrich, Claas, Gambichler, Thilo, Bluhm, Leonie, Schinagl, Heidemarie, Kellner, Ivonne, Herbst, Rudolf, Meiß, Frank, Rafei-Shamsabadi, David, Sell, Sabine, Kaatz, Martin, Wulfken, Lena, Hartmann, Martin, Kähler, Katharina, Ziemer, Mirjana, Simon, Jan, Terheyden, Patrick, Thaci, Diamant, Loquai, Carmen, Mitzel-Rink, Heidrun, Grabbe, Stephan, Stege, Henner, Gaiser, Maria, Utikal, Jochen, Berking, Carola, Heinzerling, Lucie, Schlaak, Max, Tomsitz, Dirk, Dyballa, Jörg, Magnolo, Nina, Weishaupt, Carsten, Berneburg, Mark, Garbe, Claus, Flatz, Lukas, Gesierich, Anja, Schilling, Bastian, Becker, Jürgen C, Ugurel, Selma, Leiter, Ulrike, Meier, Friedegund, Gutzmer, Ralf, Haferkamp, Sebastian, Zimmer, Lisa, Livingstone, Elisabeth, Eigentler, Thomas K, Hauschild, Axel, Kiecker, Felix, Hassel, Jessica C, Mohr, Peter, Fluck, Michael, Thomas, Ioannis, Garzarolli, Marlene, Grimmelmann, Imke, Drexler, Konstantin, Spillner, Alexandra N, Eckhardt, Sebastian, and Schadendorf, Dirk

Published
2023
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22. Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: a randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE)

Author

Merola, Joseph F, Landewé, Robert, McInnes, Iain B, Mease, Philip J, Ritchlin, Christopher T, Tanaka, Yoshiya, Asahina, Akihiko, Behrens, Frank, Gladman, Dafna D, Gossec, Laure, Gottlieb, Alice B, Thaçi, Diamant, Warren, Richard B, Ink, Barbara, Assudani, Deepak, Bajracharya, Rajan, Shende, Vishvesh, Coarse, Jason, and Coates, Laura C

Published
2023
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23. Methotrexate plus ustekinumab versus ustekinumab monotherapy in patients with active psoriatic arthritis (MUST): a randomised, multicentre, placebo-controlled, phase 3b, non-inferiority trial

Author

Alten, Rieke H.E., Benesova, Karolina, Bergner, Raoul, Braun, Jürgen, Demary, Winfried, Finzel, Stephanie, Kästner, Peter, Kleye, Arnd, Krüger, Klaus, Lorenz, Gabriele, Max, Regina, Poddubnyy, Denis, Rubbert-Roth, Andrea, Schwenke, Holger, Sieburg, Maren, Thaci, Diamant, Thiele, Astrid, Voll, Reinhard E., von Hinüber, Ulrich, Walter, Jochen, Wassenberg, Siegfried, Koehm, Michaela, Rossmanith, Tanja, Foldenauer, Ann C, Herrmann, Eva, Brandt-Jürgens, Jan, Burmester, Gerd R, Kellner, Herbert, Kiltz, Uta, Kofler, David M, Rech, Jürgen, Mojtahed-Poor, Sorwe, Jonetzko, Christin, Burkhardt, Harald, and Behrens, Frank

Published
2023
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30. Ritlecitinib, a JAK3/TEC family kinase inhibitor, stabilizes active lesions and repigments stable lesions in vitiligo.

Author

Yamaguchi, Yuji, Peeva, Elena, Duca, Ester Del, Facheris, Paola, Bar, Jonathan, Shore, Ronald, Cox, Lori Ann, Sloan, Abigail, Thaçi, Diamant, Ganesan, Anand, Han, George, Ezzedine, Khaled, Ye, Zhan, and Guttman-Yassky, Emma

Abstract

The efficacy of ritlecitinib, an oral JAK3/TEC family kinase inhibitor, on active and stable lesions was evaluated in patients with active non-segmental vitiligo in a phase 2b trial (NCT03715829). Patients were randomized to placebo or daily ritlecitinib 50 mg (with or without 4-week 100-mg or 200-mg loading dose), 30 mg, or 10 mg for 24 weeks. Active lesions showed greater baseline expression of inflammatory/immune markers IFNG and CCL5, levels of CD103, and T-cell infiltrates than stable lesions. Patients with more active than stable vitiligo lesions showed higher baseline serum levels of CXCL9 and PD-L1, while patients with more stable than active lesions showed higher baseline serum levels of HO-1. At Week 24, ritlecitinib 50 mg significantly stabilized mean percent change from baseline in depigmentation extent in both active lesions and stable lesions vs. placebo-response, with stable lesions showing greater repigmentation. After 24 weeks of treatment, ritlecitinib 50 mg increased expression of melanocyte markers in stable lesions, while Th1/Th2-related and co-stimulatory molecules decreased significantly in both stable and active lesions. Serum from patients with more active than stable lesions showed decreased levels of ICOS and NK cell activation markers. These data, confirmed at transcription/protein levels, indicate that stable lesion repigmentation occurs early with ritlecitinib, while active lesions require stabilization of inflammation first. ClinicalTrials.gov: NCT03715829. [ABSTRACT FROM AUTHOR]

Published
2024
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31. Deucravacitinib in moderate‐to‐severe plaque psoriasis: Pooled safety and tolerability over 52 weeks from two phase 3 trials (POETYK PSO‐1 and PSO‐2).

Author

Strober, Bruce, Blauvelt, Andrew, Warren, Richard B., Papp, Kim A., Armstrong, April W., Gordon, Kenneth B., Morita, Akimichi, Alexis, Andrew F., Lebwohl, Mark, Foley, Peter, Kisa, Renata M., Colston, Elizabeth, Wang, Tao, Banerjee, Subhashis, and Thaçi, Diamant

Subjects
CLINICAL trials, MAJOR adverse cardiovascular events, HERPES zoster, PSORIASIS, PROTEIN-tyrosine kinases
Abstract

Background: Two phase 3 trials, POETYK PSO‐1 and PSO‐2, previously established the efficacy and overall safety of deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, in plaque psoriasis. Objectives: To further assess the safety of deucravacitinib over 52 weeks in the pooled population from these two trials. Methods: Pooled safety data were evaluated from PSO‐1 and PSO‐2 in which patients with moderate‐to‐severe plaque psoriasis were randomized 1:2:1 to receive oral placebo, deucravacitinib or apremilast. Results: A total of 1683 patients were included in the pooled analysis. Adverse event (AE) incidence rates were similar in each treatment group, serious AEs were low and balanced across groups, and discontinuation rates were lower with deucravacitinib versus placebo or apremilast. No new safety signals emerged with longer deucravacitinib treatment. Exposure‐adjusted incidence rates of AEs of interest with placebo, deucravacitinib and apremilast, respectively, were as follows: serious infections (0.8/100 person‐years [PY], 1.7/100 PY, and 1.8/100 PY), major adverse cardiovascular events (1.2/100 PY, 0.3/100 PY, and 0.9/100 PY), venous thromboembolic events (0, 0.2/100 PY, and 0), malignancies (0, 1.0/100 PY and 0.9/100 PY), herpes zoster (0.4/100 PY, 0.8/100 PY, and 0), acne (0.4/100 PY, 2.9/100 PY, and 0) and folliculitis (0, 2.8/100 PY, and 0.9/100 PY). No clinically meaningful changes from baseline in mean levels, or shifts from baseline to CTCAE grade ≥3 abnormalities, were reported in laboratory parameters with deucravacitinib. Conclusions: Deucravacitinib was well‐tolerated with acceptable safety over 52 weeks in patients with psoriasis. [ABSTRACT FROM AUTHOR]

Published
2024
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32. Guselkumab demonstrates long-term efficacy and maintenance of treatment response postwithdrawal in systemic treatment-naïve patients and nonresponders to fumaric acid esters: results from parts II and III of a randomized active-comparator-controlled phase IIIb trial (POLARIS)

Author

Thaçi, Diamant, Pinter, Andreas, Sebastian, Michael, Termeer, Christian, Sticherling, Michael, Gerdes, Sascha, Schäkel, Knut, Wegner, Sven, Krampe, Stefanie, Bartz, Holger, Rausch, Christian, Taut, Friedemann, and Eyerich, Kilian

Subjects
*FUMARATES, *ESTERS, *QUALITY of life
Abstract

Background The anti-interleukin-23 antibody guselkumab (GUS) 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 To compare, in study part II, the sustainability of treatment responses (weeks 24–32) in GUS- and FAE-treated patients and treatment responses (weeks 32–56) in patients treated with GUS and FAE and in FAE nonresponders switching to GUS; and, in part III, to investigate the maintenance of response through week 100 in patients withdrawn from GUS at week 56. Methods At week 0, systemic treatment-naïve patients were randomized 1 : 1 to GUS or FAE as per label. At week 32, patients with a Psoriasis Area and Severity Index (PASI) 75 (≥ 75% improvement in PASI score) response (r) continued assigned treatment (GUSr-GUS; FAEr-FAE), whereas nonresponders (nr) received GUS (FAEnr-GUS; GUSnr-GUS). GUS-treated patients with a week 56 PASI 90 response (≥ 90% improvement in PASI score) were withdrawn (w) and followed until loss of response or week 100. Results At week 32, 98% (n = 54/55) of GUS- and 41% (n = 14/34) of FAE-treated patients were PASI 75 responders. At week 56, 91%, 50% and 80% of GUSr-GUS, FAEr-FAE and FAEnr-GUS patients, respectively, achieved a PASI 90 response; 72%, 29% and 45%, respectively, achieved a Dermatology Life Quality Index score of 0/1. At week 100, 44 weeks postwithdrawal, 47% (n = 17/36) and 25% (n = 3/12) of GUS-GUSw and FAE-GUSw patients, respectively, maintained a PASI score ≤ 5. Overall, the adverse event and discontinuation rates were lower for GUS than FAE. Conclusions In these exploratory analyses, GUS, as a first-line systemic treatment or second-line systemic treatment in FAE nonresponders, was associated with long-term clinical efficacy up to week 100, including a withdrawal period. [ABSTRACT FROM AUTHOR]

Published
2024
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33. SARS‐CoV‐2‐Infektionen bei Patienten mit Psoriasis in Deutschland: Daten aus den deutschen Registern PsoBest und CoronaBest.

Author

López, María José Valencia, Meineke, Anna, Stephan, Brigitte, Rustenbach, Stephan Jeff, Kis, Anne, Thaçi, Diamant, Mrowietz, Ulrich, Reich, Kristian, Staubach‐Renz, Petra, von Kiedrowski, Ralph, Bogena, Henriette, and Augustin, Matthias

Abstract

Copyright of Journal der Deutschen Dermatologischen Gesellschaft is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2024
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34. SARS‐CoV‐2 infection among psoriasis patients in Germany: Data from the German registries PsoBest and CoronaBest.

Author

López, María José Valencia, Meineke, Anna, Stephan, Brigitte, Rustenbach, Stephan Jeff, Kis, Anne, Thaçi, Diamant, Mrowietz, Ulrich, Reich, Kristian, Staubach‐Renz, Petra, von Kiedrowski, Ralph, Bogena, Henriette, and Augustin, Matthias

Abstract

Summary: Background: Limited data exist on the characteristics of SARS‐CoV‐2 infections in German patients with psoriasis or psoriasis arthritis (PsA). This study analyses COVID‐19 prevalence and severity of symptoms in these patients. Patients and Methods: Participants of the German registries PsoBest and CoronaBest were surveyed in February 2022. Descriptive analyses were conducted. Results: 4,818 patients were included in the analysis, mean age of 56.4 years. Positive SARS‐CoV‐2 tests were reported by 737 (15.3%) patients. The most frequently reported acute symptoms were fatigue (67.3%), cough (58.8%), and headache (58.3%). Longer‐lasting symptoms after COVID‐19 were reported by 231 of 737 patients after the acute phase. For most patients (92.9%), systemic treatment for their psoriasis or PsA was not modified during the pandemic. Patients positively tested for SARS‐CoV‐2 were younger on average and had more often changes in the therapy of psoriasis than negatively tested patients (8.5% vs. 5.4%). Conclusions: In this cohort of patients with psoriasis or PsA undergoing systemic treatment, SARS‐CoV‐2 infections were common but less frequent than in the general German population. No risk signals for more severe COVID‐19 or increased infection rates were observed in the patients. In addition, systemic treatments remained largely unchanged, so that no risks can be attributed to these therapies. [ABSTRACT FROM AUTHOR]

Published
2024
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40. Dupilumab Improves Asthma and Sinonasal Outcomes in Adults with Moderate to Severe Atopic Dermatitis

Author

Boguniewicz, Mark, Beck, Lisa A., Sher, Lawrence, Guttman-Yassky, Emma, Thaçi, Diamant, Blauvelt, Andrew, Worm, Margitta, Corren, Jonathan, Soong, Weily, Lio, Peter, Rossi, Ana B., Lu, Yufang, Chao, Jingdong, Eckert, Laurent, Gadkari, Abhijit, Hultsch, Thomas, Ruddy, Marcella, Mannent, Leda P., Graham, Neil M.H., Pirozzi, Gianluca, Chen, Zhen, and Ardeleanu, Marius

Published
2021
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41. Risk of cardiovascular disorders in hidradenitis suppurativa patients: a large‐scale, propensity‐matched global retrospective cohort study.

Author

Krajewski, Piotr K, Matusiak, Łukasz, Ständer, Sascha, Thaçi, Diamant, Szepietowski, Jacek C, and Zirpel, Henner

Subjects
CARDIOVASCULAR diseases, HIDRADENITIS suppurativa, CARDIOVASCULAR diseases risk factors, MYOCARDIAL infarction, VENOUS thrombosis, TUMOR necrosis factors, HEART failure
Abstract

Background: Patients with hidradenitis suppurativa (HS) often suffer from comorbid diabetes, metabolic syndrome, and hyperlipidemia and, therefore, are susceptible to the development of cardiovascular diseases (CVDs). Moreover, systemic inflammation plays a vital role in the development of atherosclerosis. The creation of atherosclerotic plaque is characterized by endothelial dysfunction driven by elevated concentrations of interleukin (IL)‐1, IL‐6, and IL‐18 among others, as well as tumor necrosis factor (TNF) alpha. Methods: This study aimed to assess the risk of HS patients developing CVDs. We performed a large‐scale, propensity‐matched global retrospective cohort study analyzing the risk of development of CVDs in patients suffering from HS. The analysis included 144,100 HS patients with 144,100 healthy controls (HC). The cohorts were matched regarding demographics and history of diseases relevant to CVDs, e.g., diabetes, obesity, and nicotine dependence. A total of 90 cardiovascular disorders were identified. The identification of cardiovascular disorders was based on ≥1% appearance of the event, based on absolute numbers, in both cohorts. Results: Before the matching, HS patients displayed a higher frequency in excess weight or obesity (25 vs. 14.4%, respectively), nicotine dependence, and diabetes mellitus, but lower odds of primary hypertension in comparison to healthy controls. A total of 47 CVDs are associated with an increased risk of onset in HS patients. Although the highest hazard ratio (HR; 2.1; 95% CI: 1.95–2.269) was found for unspecified heart failure, the HS cohort was exceptionally predisposed to developing myocardial infarction (HR: 2.06; 95% CI: 1.88–2.27) and an acute embolism and deep vein thrombosis of the lower extremity (HR: 1.93; 95% CI: 1.74–2.14). Conclusions: This is the most extensive study on the association of HS with CVDs. We demonstrated that HS patients are at significantly greater risk of developing various CVDs compared to matched controls, with heart failure being the most common one. [ABSTRACT FROM AUTHOR]

Published
2024
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42. Deucravacitinib in plaque psoriasis: 2-year safety and efficacy results from the phase III POETYK trials.

Author

Lebwohl, Mark, Warren, Richard B, Sofen, Howard, Imafuku, Shinichi, Paul, Carle, Szepietowski, Jacek C, Spelman, Lynda, Passeron, Thierry, Vritzali, Eleni, Napoli, Andrew, Kisa, Renata M, Buck, Alex, Banerjee, Subhashis, Thaçi, Diamant, and Blauvelt, Andrew

Subjects
CLINICAL trials, MAJOR adverse cardiovascular events, COVID-19 pandemic, HERPES zoster, PSORIASIS
Abstract

Background In the phase III POETYK PSO-1 and PSO-2 trials, deucravacitinib, an oral selective allosteric tyrosine kinase 2 inhibitor, was well tolerated and efficacious over 1 year in patients with psoriasis. Objective To evaluate deucravacitinib safety and efficacy over 2 years in patients participating in the phase III trials. Methods In the POETYK long-term extension (LTE), an ongoing phase IIIb open-label trial, adults with moderate-to-severe plaque psoriasis who completed PSO-1 or PSO-2 receive deucravacitinib 6 mg once daily. Safety was assessed via adverse events (AEs) and laboratory parameter abnormalities. Efficacy endpoints, including ≥ 75% reduction from baseline Psoriasis Area and Severity Index score (PASI 75) and static Physician's Global Assessment (sPGA) score of 0/1 (clear/almost clear), were evaluated in patients originally randomized to deucravacitinib, patients who crossed over from placebo at week 16 and patients who achieved PASI 75 at week 24 (peak efficacy). Results At data cutoff (1 October 2021), 1519 patients had received at least one dose of deucravacitinib; 79.0% and 39.9% had ≥ 52 weeks and ≥ 104 weeks of total deucravacitinib exposure, respectively. Exposure-adjusted incidence rates (EAIRs) per 100 person-years were similar at 1 year and 2 years for any AEs (229.2 vs. 154.4, respectively), serious AEs (5.7 vs. 6.1), discontinuations (4.4 vs. 2.8), deaths (0.2 vs. 0.4), serious infections (1.7 vs. 2.6), herpes zoster (0.9 vs. 0.8), major adverse cardiovascular events (0.3 vs. 0.4), venous thromboembolic events (0.2 vs. 0.1) and malignancies (1.0 vs. 0.9). EAIRs for COVID-19 infections were higher at 2 years than at 1 year (5.1 vs. 0.5) owing to the peak of the global COVID-19 pandemic occurring during the LTE. No clinically meaningful changes from baseline or trends were observed over 2 years in haematological, chemistry or lipid parameters. Clinical responses were maintained in patients who received continuous deu-cravacitinib treatment from baseline [PASI 75: week 52, 72.4%; week 112, 79.7%; sPGA 0/1: week 52, 57.9%; week 112, 61.1% (as observed)]. Responses at week 52 were also maintained in placebo crossovers and in week-24 PASI-75 responders. Conclusions Deucravacitinib maintained efficacy and demonstrated consistent safety with no new safety signals observed through 2 years. [ABSTRACT FROM AUTHOR]

Published
2024
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43. Bimekizumab safety in patients with moderate-to-severe plaque psoriasis: pooled data from up to 3 years of treatment in randomized phase III trials.

Author

Gordon, Kenneth B, Langley, Richard G, Warren, Richard B, Okubo, Yukari, Rosmarin, David, Lebwohl, Mark, Peterson, Luke, Madden, Cynthia, Cuyper, Dirk de, Davies, Owen, and Thaçi, Diamant

Subjects
CLINICAL trials, PATIENT safety, RESPIRATORY infections, INFLAMMATORY bowel diseases, THRUSH (Mouth disease)
Abstract

Background Patients with psoriasis require long-term management; therefore, understanding the long-term safety of new treatments, such as bimekizumab (BKZ), is crucial. Objectives To evaluate BKZ's 3-year safety profile in patients with moderate-to-severe plaque psoriasis. Methods Three years of safety data were pooled from three phase III trials (BE VIVID, BE READY and BE SURE) and their ongoing open-label extension (BE BRIGHT). Treatment-emergent adverse events (TEAEs) are reported using exposure-adjusted incidence rates (EAIRs) per 100 patient-years (PY). Results In total, 1495 patients received at least one BKZ dose; total BKZ exposure was 3876.4 PY. The overall EAIR of TEAEs was 175.5/100 PY and decreased with longer exposure to BKZ. The most commonly reported TEAEs were nasopharyngitis, oral candidiasis and upper respiratory tract infection (EAIRs of 15.0/100 PY, 10.1/100 PY and 6.5/100 PY, respectively); 99.3% of oral candidiasis events were mild or moderate in severity, none were serious and few led to discontinuation. EAIRs of other TEAEs of interest were low, including serious infections (1.2/100 PY), adjudicated inflammatory bowel disease (0.2/100 PY) and laboratory elevations in aspartate aminotransferase or alanine aminotransferase (> 5 × upper limit of normal: 0.6/100 PY). Conclusions In these analyses pooled across 3 years, no new safety signals were observed with longer exposure to BKZ. The vast majority of oral candidiasis events were mild or moderate in severity, as reported previously. [ABSTRACT FROM AUTHOR]

Published
2024
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45. Price variability of TNF‐α inhibitor biosimilars among European countries.

Author

Geat, Davide, Gisondi, Paolo, Maurelli, Martina, Puig, Luis, Paul, Carle, Thaçi, Diamant, Iversen, Lars, Bellinato, Francesco, and Girolomoni, Giampiero

Subjects
PRICES, BIOSIMILARS, ADALIMUMAB, SUSTAINABILITY, PSORIATIC arthritis, VALUE-added tax
Abstract

This article discusses the price variability of TNF-α inhibitor biosimilars for the treatment of psoriasis across European countries. The study found that there is significant price variability, with lower prices in Italy and Spain compared to Germany, France, and Denmark. The pricing policies adopted by different countries, such as mandatory discounts, progressive price discounts, and tendering or direct contracting, contribute to this variability. The findings highlight the potential impact on healthcare costs and patient access to biological treatment. However, it is important to note that the study only included one center per country. [Extracted from the article]

Published
2024
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48. Dupilumab Provides Favorable Safety and Sustained Efficacy for up to 3 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis

Author

Beck, Lisa A., Thaçi, Diamant, Deleuran, Mette, Blauvelt, Andrew, Bissonnette, Robert, de Bruin-Weller, Marjolein, Hide, Michihiro, Sher, Lawrence, Hussain, Iftikhar, Chen, Zhen, Khokhar, Faisal A., Beazley, Bethany, Ruddy, Marcella, Patel, Naimish, Graham, Neil M. H., Ardeleanu, Marius, and Shumel, Brad

Published
2020
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