6 results on '"Thaçi, Diamant"'
Search Results
2. Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial
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Thaçi, Diamant, Strober, Bruce, Gordon, Kenneth B., Foley, Peter, Gooderham, Melinda, Morita, Akimichi, Papp, Kim A., Puig Sanz, Lluís, Menter, M. Alan, Colombo, Matthew J., Elbez, Yedid, Kisa, Renata M., Ye, June, Napoli, Andrew A., Wei, Lan, Banerjee, Subhashis, Merola, Joseph F., Gottlieb, Alice B., and Universitat Autònoma de Barcelona
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Body surface area ,Quality of life ,Humans ,Psoriasis ,Dermatology ,TYK2 ,humanities - Abstract
Introduction Deucravacitinib is an oral, selective tyrosine kinase 2 inhibitor that demonstrated therapeutic benefit in a Phase 2 clinical trial of adults with moderate to severe plaque psoriasis. This analysis was designed to evaluate the effect of deucravacitinib on additional clinical and quality-of-life (QoL) outcomes and assess the relationship between these outcomes in adults with psoriasis. Methods Post-hoc analysis of a 12-week Phase 2 trial was conducted for the three most efficacious dosage groups (3 mg twice daily, 6 mg twice daily, 12 mg once daily) and placebo. Investigator assessments for efficacy included Psoriasis Area and Severity Index (PASI), body surface area (BSA) involvement, and static Physician's Global Assessment; QoL was assessed using the Dermatology Life Quality Index (DLQI). Treatment responses and their associations were evaluated over time. Results Deucravacitinib elicited improvement versus placebo as early as Week 4 for most efficacy measures (including changes in absolute PASI and BSA), with efficacy trends observed from Week 2 to Week 12. Improvements in QoL, assessed by achievement of a DLQI overall score of 0/1 (no effect at all on patient's life), followed a pattern similar to deucravacitinib-related clinical outcomes over 12 weeks. Overall, patients with greater improvements in psoriasis-related clinical signs and symptoms also reported greater improvement in QoL. However, complete skin clearance was not required for achieving DLQI 0/1. Conclusion Deucravacitinib treatment produced early response and similar trends in improvements across multiple efficacy assessments and QoL in moderate to severe plaque psoriasis. Deucravacitinib has the potential to become a promising new oral therapy for this condition. Plain Language Summary Psoriasis is a skin disease that affects up to 2% of the population. In psoriasis, red, scaly lesions develop on the skin driven by an aberrant immune response. Psoriasis impacts not only physical and mental health but also quality of life (QoL). Deucravacitinib is being investigated as a treatment for psoriasis. We performed a Phase 2 dose-ranging, placebo-controlled, 12-week study of deucravacitinib in adults with moderate to severe psoriasis. Patients in the USA, Australia, Canada, Germany, Japan, Latvia, Mexico, and Poland participated. The study showed that oral treatment with deucravacitinib was effective using a disease severity score (percentage of patients with >= 75% reduction from baseline in Psoriasis Area and Severity Index score) at Week 12-placebo 7% and deucravacitinib 67%-75% for the three highest dosages-and was generally well tolerated. We further analyzed the association between efficacy and a QoL measure, the Dermatology Life Quality Index (DLQI), in patients who received placebo or the most effective dosages of deucravacitinib (>= 3 mg twice daily). Deucravacitinib was effective at the three dosage levels tested. Skin improvement occurred early during treatment and was mirrored by improvements in DLQI score during the 12 weeks of treatment. Although some patients did not have complete clearance of their psoriasis, a large percentage of those patients still achieved considerable improvement in QoL as measured by achieving a DLQI score of 0/1 (i.e., no effect at all on the patient's QoL).
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- 2022
3. Secukinumab demonstrates sustained efficacy in clearing skin and improving patient-reported outcomes in patients with moderate-to-severe psoriasis through 2 years of treatment : Results from the CLEAR study
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Thaçi, Diamant, Puig Sanz, Lluís., Reich, K., Tsai, T.F., Tyring, S., Kingo, K., Ziv, M., Pinter, A., Vender, R., Lacombe, A., Xia, S., Bhosekar, V., Gilloteau, I., Guana, A., Blauvelt, A., and Universitat Autònoma de Barcelona
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medicine.medical_specialty ,business.industry ,Moderate to severe psoriasis ,MEDLINE ,Dermatology ,Treatment results ,law.invention ,Randomized controlled trial ,law ,Internal medicine ,Severity of illness ,Monoclonal ,Medicine ,In patient ,Secukinumab ,business - Abstract
Altres ajuts: The authors thank Dhaval Gupta, MPH (Novartis Healthcare Pvt Ltd, India), and Jackie L. Johnson, PhD (Novartis Ireland Ltd), for providing medical writing support, which was funded by Novartis Pharma AG, Basel, Switzerland, in accordance with Good Publication Practice guidelines (http://www.ismpp.org/gpp3).
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- 2019
4. Benefit-risk profile of tofacitinib in patients with moderate-to-severe chronic plaque psoriasis : pooled analysis across six clinical trials
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Strober, B.E., Gottlieb, A.B., van de Kerkhof, P.C.M., Puig Sanz, Lluís., Bachelez, Hervé, Chouela, E., Imafuku, S., Thaçi, Diamant, Tan, H., Valdez, H., Gupta, P., Kaur, M., Frajzyngier, V., Wolk, R., and Universitat Autònoma de Barcelona
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Adult ,Male ,medicine.medical_specialty ,Adolescent ,Administration, Oral ,Dermatology ,Placebo ,Risk Assessment ,Severity of Illness Index ,030207 dermatology & venereal diseases ,03 medical and health sciences ,Young Adult ,All institutes and research themes of the Radboud University Medical Center ,0302 clinical medicine ,Piperidines ,Psoriasis Area and Severity Index ,Internal medicine ,Psoriasis ,Severity of illness ,medicine ,Janus Kinase Inhibitors ,Humans ,Pyrroles ,Protein Kinase Inhibitors ,Janus kinase inhibitor ,Aged ,Randomized Controlled Trials as Topic ,Aged, 80 and over ,Tofacitinib ,Dose-Response Relationship, Drug ,business.industry ,Original Articles ,Dermatology Life Quality Index ,Middle Aged ,medicine.disease ,Clinical Trial ,Clinical trial ,Pyrimidines ,Chronic Disease ,Inflammatory diseases Radboud Institute for Health Sciences [Radboudumc 5] ,Quality of Life ,Female ,business - Abstract
Summary Background Although existing psoriasis treatments are effective and well tolerated in many patients, there is still a need for new effective targeted treatment options. Tofacitinib is an oral Janus kinase inhibitor that has been investigated in patients with moderate‐to‐severe chronic plaque psoriasis. Objectives To consider the benefits and risks of tofacitinib in patients with moderate‐to‐severe psoriasis. Methods Data were pooled from one phase II, four phase III and one long‐term extension study comprising 5204 patient‐years of tofacitinib treatment. Efficacy end points included patients achieving Physician's Global Assessments of ‘clear’ or ‘almost clear’, ≥ 75% and ≥ 90% reduction in Psoriasis Area and Severity Index (coprimary end points) and improvements in Dermatology Life Quality Index score, Hospital Anxiety and Depression Scale depression score and Itch Severity Item score, at weeks 16 and 52. Safety data were summarized for 3 years of tofacitinib exposure. Results Tofacitinib 5 and 10 mg twice daily (BID) showed superiority over placebo for all efficacy end points at week 16, with response maintained for 52 weeks of continued treatment. Tofacitinib improved patients’ quality of life and was well tolerated. Rates of safety events of interest (except herpes zoster) were similar to those in the published literature and healthcare databases for other systemic psoriasis therapies. Tofacitinib 10 mg BID demonstrated greater efficacy than 5 mg BID. Conclusions Tofacitinib has a benefit–risk profile in moderate‐to‐severe psoriasis consistent with that of other systemic treatments., What's already known about this topic? Psoriasis is a chronic, systemic inflammatory disease, which has a significant impact on patients’ health‐related quality of life.Although several existing psoriasis treatments are efficacious and well tolerated in many patients, some patients require treatment switching, and a proportion of patients remain untreated or undertreated.Potential challenges to the use of existing therapies include safety issues and limited efficacy in some patients with conventional oral psoriasis treatments, inconvenience of topical treatments and the requirement for parenteral administration of biologics. What does this study add? Consistent efficacy and a safety profile consistent with that seen in rheumatoid arthritis, psoriatic arthritis and ulcerative colitis were demonstrated for oral tofacitinib in patients with moderate‐to‐severe psoriasis.Tofacitinib has a benefit–risk profile in patients with moderate‐to‐severe psoriasis that is consistent with that of other systemic psoriasis treatments. Linked Comment: Fleming. Br J Dermatol 2019; 180:13–14. Plain language summary available online Respond to this article
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- 2019
5. Secukinumab demonstrates sustained efficacy in clearing skin and improving patient-reported outcomes in patients with moderateto-severe psoriasis through 2 years of treatment: Results from the CLEAR study
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Thaçi, Diamant, Puig, Lluís, Reich, Kristian, Tsai, Tsen-Fang, Tyring, Stephen, Kingo, Kulli, Ziv, Michael, Pinter, Andreas, Vender, Ronald, Lacombe, Aude, Xia, Summer, Bhosekar, Vaishali, Gilloteau, Isabelle, Guana, Adriana, and Blauvelt, Andrew
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ddc:610 - Abstract
Secukinumab is a fully human monoclonal antibody that selectively neutralizes interleukin 17A, a key cytokine involved in the development of psoriasis. Secukinumab has shown long-lasting efficacy and safety in the complete spectrum of psoriatic disease, including disease localized to nails, scalp, palms and soles, and joints (peripheral and axial arthritis). Given the chronic and relapsing nature of psoriasis, long-term data might help to fully characterize the efficacy and safety profile of secukinumab as well as its impact on quality of life.
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- 2019
6. The topical calcineurin inhibitor pimecrolimus in atopic dermatitis: A safety update
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Salgo, Rebekka and Thaçi, Diamant
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