Article
Dermatology
Sk Shahriar Ahmed, Abhishek De, Sudip Das, Yashpal Manchanda
Summary: Psoriasis is a chronic inflammatory skin disease that affects around 2-3% of the population. Advancements in understanding its pathogenesis have led to new treatment options, such as biologics. Biologics, including TNF-a inhibitors, IL-12/23 inhibitors, IL-17 inhibitors, and CD-6 inhibitors, have shown high efficacy and safety in clinical trials. Long-term follow-up and post-marketing surveillance are necessary to understand the long-term effectiveness and adverse events of these potent drugs.
INDIAN JOURNAL OF DERMATOLOGY
(2023)
Article
Dermatology
Sam G. Raney, Priyanka Ghosh, Tannaz Ramezanli, Paul A. Lehman, Thomas J. Franz
Summary: The practical assessment of bioequivalence (BE) for each drug product involves characterizing a multidimensional topography of product attributes and behavior. The physiochemical and structural complexity of semisolid drug products should be considered in the design of bioequivalent drug products. In addition, in vitro and/or in vivo tests of product performance and evidence from orthogonal methods can be used to support a demonstration of BE.
DERMATOLOGIC CLINICS
(2022)
Article
Dermatology
Nikolai Loft, Alexander Egeberg, Mads Kirchheiner Rasmussen, Lars Erik Bryld, Christoffer Valdemar Nissen, Tomas Norman Dam, Kawa Khaled Ajgeiy, Lars Iversen, Lone Skov
Summary: This cohort study from Denmark assessed the outcomes of patients switching from adalimumab originator to adalimumab biosimilars, and found that the switch was not associated with drug retention.
Review
Pharmacology & Pharmacy
Deeksha Joshi, Rubiya Khursheed, Saurabh Gupta, Diksha Wadhwa, Thakur Gurjeet Singh, Sumit Sharma, Sejal Porwal, Swati Gauniyal, Sukriti Vishwas, Sanjay Goyal, Gaurav Gupta, Rajaraman D. Eri, Kylie A. Williams, Kamal Dua, Sachin Kumar Singh
Summary: Biologic-based medicines, including biosimilars, have the potential to enhance cancer treatment by providing lower-cost options and increasing accessibility. However, there are challenges such as cost, immunogenicity, lack of awareness, extrapolation of indications, and interchangeability.
Review
Medical Laboratory Technology
Arkadiusz Kocur, Pawel K. Kunicki, Tomasz Pawinski
Summary: Immunosuppressants with narrow therapeutic indices (NTIDs), such as cyclosporine, tacrolimus, everolimus, and sirolimus, raise concerns about the introduction of generics into the drug market and the need for bioequivalence testing. Different regulatory agencies have different acceptance criteria for bioequivalence, with the European Union and Canada adopting specific ranges for the area under the curve (AUC) while the US FDA uses classic acceptance criteria. This study discusses the need for a global consensus on bioequivalence testing for NTIDs and highlights the importance of careful drug switching and therapeutic drug monitoring in patients.
THERAPEUTIC DRUG MONITORING
(2023)
Review
Chemistry, Analytical
Ratih Ratih, Mufarreh Asmari, Ahmed M. Abdel-Megied, Fawzy Elbarbry, Sami El Deeb
Summary: Biologics have complex production processes and face various challenges, including similarity testing and international regulatory guidelines. Since 2006, biosimilars have entered the biotechnology arena with intense competition.
MICROCHEMICAL JOURNAL
(2021)
Article
Pharmacology & Pharmacy
Huarui Shao, Yi Tao, Chengyong Tang
Summary: This study aimed to explore the factors affecting the bioequivalence of test and reference insulin preparations. A multivariate statistical model was used to analyze the influencing factors, and a structural equation model (SEM) was constructed. The results showed that adverse events and bioactive substance content significantly impacted the bioequivalence, and bioactive substance content also affected adverse events. Rating: 9/10.
FRONTIERS IN PHARMACOLOGY
(2023)
Article
Chemistry, Medicinal
Wanjun Bai, Haojing Song, Yiting Hu, Xueyuan Zhang, Xiaoru Wang, Caihui Guo, Bo Qiu, Zhanjun Dong
Summary: This study compared the pharmacokinetics and safety of generic and original vortioxetine hydrobromide tablets under fasting and fed conditions. The results showed that the pharmacokinetic parameters of the test drug were similar to those of the reference drug, indicating bioequivalence. Both formulations were safe and well-tolerated in healthy Chinese subjects.
DRUG DESIGN DEVELOPMENT AND THERAPY
(2023)
Article
Chemistry, Medicinal
Jin Wang, Huan Zhang, Rui Wang, Yun Cai
Summary: In this study, the pharmacokinetics, bioequivalence and safety profiles of 90 mg ticagrelor tablets and their active metabolite were evaluated in healthy Chinese subjects under fasting and fed conditions. The results showed no significant differences in PK parameters and bioequivalence between the test and reference drugs, with no severe adverse events observed.
DRUG DESIGN DEVELOPMENT AND THERAPY
(2021)
Review
Behavioral Sciences
Roberta Roberti, Alessandro Casarella, Alfonso Iudice, Angela La Neve, Ettore Beghi, Giuseppe Capovilla, Carlo Di Bonaventura, Filippo S. Giorgi, Salvatore Grosso, Luigi F. Iannone, Andrea Romigi, Luigi M. Specchio, Gaetano Zaccara, Oriano Mecarelli, Emilio Russo
Summary: The article reviews the use of generic drugs in the treatment of epilepsy, finding that generic ASMs have similar efficacy and safety as branded drugs, with cost advantages. The study suggests avoiding switching between branded and generic (or vice versa) or between different generics during seizure remission.
EPILEPSY & BEHAVIOR
(2021)
Review
Health Care Sciences & Services
Lucia Gozzo, Filippo Caraci, Filippo Drago
Summary: The prescription of generic drugs is an important cost-containment strategy in health systems. Regulatory authorities encourage or require the use of generic drugs due to their lower price compared to brand-name alternatives. However, drug substitution can be critical, especially for drugs with a narrow therapeutic index. Additionally, generics cannot be automatically considered bioequivalent due to the biocreep phenomenon.
Article
Immunology
Saeideh Sadat Shobeiri, Motahareh Khorrami, Mojtaba Sankian
Summary: Psoriasis is a common inflammatory skin disorder mediated by the immune system, affecting 1-4% of the world's population. Treatments include topical therapy, phototherapy, systemic drugs, and advancing options like biological drugs, bispecific agents, and small molecule drugs to provide patients with more treatment choices.
INTERNATIONAL IMMUNOPHARMACOLOGY
(2021)
Article
Pharmacology & Pharmacy
Gang Mai, Lianlian Fan, Mupeng Li, Peiwen Zhang, Chunyan Gan, Qian Huang, Jianzhong Shentu
Summary: The study demonstrated pharmacokinetic similarity between LRG201902 and Victoza(R) in healthy subjects, with comparable safety and immunogenicity profiles in the two products.
FRONTIERS IN PHARMACOLOGY
(2021)
Article
Medicine, General & Internal
Jenny M. Norlin, Sofia Loefvendahl, Marcus Schmitt-Egenolf, Stamatis Gregoriou, Emmanuel Andres
Summary: This study investigated the influence of socioeconomic factors on access to biologics for psoriasis. The findings showed that, after adjusting for disease severity and lifestyle factors, the higher-income group had better access to biologics compared to the middle-income group.
JOURNAL OF CLINICAL MEDICINE
(2023)
Article
Dermatology
Gayle van der Kraaij, Celine Busard, Juul van den Reek, Stef Menting, Annelie Musters, Barbara Hutten, Menno de Rie, Wouter Ouwerkerk, Sun-Jine Van Bezooijen, Errol Prens, Theo Rispens, Annick de Vries, Elke de Jong, Wim de Kort, Jo Lambert, Martijn van Doorn, Phyllis Spuls
Summary: This study evaluated the efficacy, safety, and pharmacokinetic profile of adalimumab combined with methotrexate in the treatment of chronic plaque psoriasis. The results showed that combination therapy resulted in fewer patients showing antidrug antibodies and a trend towards improved treatment response.
JOURNAL OF INVESTIGATIVE DERMATOLOGY
(2022)
Article
Dermatology
Georgios Kokolakis, Richard B. Warren, Bruce Strober, Andrew Blauvelt, Luis Puig, Akimichi Morita, Melinda Gooderham, Andreas Koerber, Veerle Vanvoorden, Maggie Wang, Dirk de Cuyper, Cynthia Madden, Natalie Nunez Gomez, Mark Lebwohl
Summary: This study evaluated the efficacy and safety of switching to bimekizumab from adalimumab, ustekinumab, and secukinumab. The results showed rapid and durable improvements in clinical responses among nonresponders who switched to bimekizumab. Furthermore, the majority of patients who responded well to previous treatments maintained or improved their response after switching to bimekizumab. Overall, switching to bimekizumab was found to be highly effective and well tolerated for psoriasis patients.
BRITISH JOURNAL OF DERMATOLOGY
(2023)
Article
Dermatology
Diamant Thaci, Ron Vender, Menno A. de Rie, Curdin Conrad, David M. Pariser, Bruce Strober, Veerle Vanvoorden, Maggie Wang, Cynthia Madden, Dirk de Cuyper, Alexa B. Kimball
Summary: The clinical and health-related quality of life responses observed during the first 16 weeks of BE SURE were sustained over 2 years of treatment, regardless of bimekizumab maintenance dosing. Switching from adalimumab to bimekizumab also resulted in sustained improvements up to Week 104. Bimekizumab had a good safety profile with no new safety signals.
BRITISH JOURNAL OF DERMATOLOGY
(2023)
Article
Dermatology
David Gleeson, Jonathan N. W. N. Barker, Francesca Capon, Andrew E. Pink, Richard T. Woolf, Catherine H. Smith, Satveer K. Mahil
Summary: We conducted a critical assessment of the literature and found that Janus kinase inhibitors, specifically tofacitinib, showed promising therapeutic effects for palmoplantar pustulosis, based on case reports and case series. However, due to the limited evidence and uncertain safety profile, the routine use of Janus kinase inhibitors for this condition is not recommended outside of clinical trials.
BRITISH JOURNAL OF DERMATOLOGY
(2023)
Article
Dermatology
Sophia Quirke-McFarlane, John Weinman, Emma S. Cook, Zenas Z. N. Yiu, Nick Dand, Sinead M. Langan, Katie Bechman, Teresa Tsakok, Kayleigh J. Mason, Helen McAteer, Freya Meynell, Bolaji Coker, Alexandra Vincent, Dominic Urmston, Amber Vesty, Jade Kelly, Camille Lancelot, Lucy Moorhead, Ines A. Barbosa, Herve Bachelez, Francesca Capon, Claudia R. Contreras, Claudia De La Cruz, Paola Di Meglio, Paolo Gisondi, Denis Jullien, Jo Lambert, Luigi Naldi, Lluis Puig, Phyllis Spuls, Tiago Torres, Richard B. Warren, Hoseah Waweru, James B. Galloway, Christopher E. M. Griffiths, Jonathan N. Barker, Sam Norton, Catherine H. Smith, Satveer K. Mahil
Summary: This study investigated the nonadherence to immune-modifying therapy in individuals with psoriasis during the COVID-19 pandemic and its association with mental health. The most common reason for nonadherence was concerns about immunity. After adjusting for potential confounders, the association between anxiety and nonadherence to immune-modifying therapy became weaker and no longer significant. This study highlights the importance of clear and adequate communication with patients during a pandemic.
BRITISH JOURNAL OF DERMATOLOGY
(2023)
Article
Dermatology
Jonathan I. I. Silverberg, Lars E. E. French, Richard B. B. Warren, Bruce Strober, Kim Kjoller, Morten O. A. Sommer, Philippe Andres, Jakob Felding, Anne Weiss, Deniz Tutkunkardas, Tine Skak-Nielsen, Emma Guttman
Summary: This study examined the PDE4 enzymatic activity and anti-inflammatory effects of orismilast in vitro, ex vivo, and in vivo. The results showed that orismilast selectively and potently inhibited PDE4 and demonstrated broad-spectrum anti-inflammatory activity. These findings support the clinical development of oral orismilast as a novel treatment option for chronic inflammatory skin diseases.
JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY
(2023)
Article
Dermatology
Richard B. B. Warren, Bruce Strober, Jonathan I. I. Silverberg, Emma Guttman, Philippe Andres, Jakob Felding, Deniz Tutkunkardas, Kim Kjoller, Morten O. A. Sommer, Lars E. E. French
Summary: This study aimed to examine the efficacy and safety of orismilast for psoriasis treatment. The phase 2a trial found that orismilast significantly improved the condition of patients with psoriasis. The phase 1 trial tested new formulations to minimize gastrointestinal adverse reactions.
JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY
(2023)
Article
Psychology, Clinical
Neli T. Pavlova, Celeny Ramasawmy, Federica Picariello, Catherine Smith, Rona Moss-Morris
Summary: Most psoriasis patients do not believe there is a connection between obesity and psoriasis. They tend to engage in weight loss programs in order to control the severity of psoriasis and improve symptoms. Emotional discomfort can lead patients to comfort eat as a coping mechanism. Patients are unsatisfied with current generic weight loss recommendations and desire a program that includes emotional and behavioral support.
BRITISH JOURNAL OF HEALTH PSYCHOLOGY
(2023)
Article
Dermatology
Bruce Strober, Yayoi Tada, Ulrich Mrowietz, Mark Lebwohl, Peter Foley, Richard G. Langley, Richard B. Warren, Maggie Wang, Veerle Vanvoorden, Balint Szilagyi, Valerie Ciaravino, Carle Paul
Summary: It is important to evaluate the long-term efficacy of new treatments for psoriasis. This study found that the majority of patients who responded to bimekizumab treatment at Week 16 maintained a high level of clinical response after 3 years of treatment. These findings demonstrate the long-term effectiveness of bimekizumab in patients with moderate-to-severe plaque psoriasis and its important benefits for health-related quality of life.
BRITISH JOURNAL OF DERMATOLOGY
(2023)
Article
Dermatology
Angela L. Bosma, Louise A. A. Gerbens, Hajar El Khattabi, Floris C. Loeff, Michael Duckworth, Richard T. Woolf, Theo Rispens, Catherine H. Smith, Phyllis I. Spuls
Summary: This study investigated the clinical relevance of dupilumab serum concentration in atopic dermatitis patients. The results showed that the concentration of dupilumab is not associated with treatment effectiveness, but disease activity does seem to influence its levels.
JOURNAL OF DERMATOLOGICAL TREATMENT
(2023)
Letter
Dermatology
Jake R. Saklatvala, Ken B. Hanscombe, Satveer K. Mahil, Lam C. Tsoi, James T. Elder, Jonathan N. Barker, Michael A. Simpson, Catherine H. Smith, Nick Dand
JOURNAL OF INVESTIGATIVE DERMATOLOGY
(2023)
Article
Dermatology
Ali Al-Janabi, Steve Eyre, Amy C. Foulkes, Adnan R. Khan, Nick Dand, Ekaterina Burova, Bernadette DeSilva, Areti Makrygeorgou, Emily Davies, Catherine H. Smith, Christopher E. M. Griffiths, Andrew P. Morris, Richard B. Warren, BSTOP Study Grp, BADBIR Study Grp
Summary: Genetic factors play a role in the development of paradoxical eczema in patients with psoriasis receiving biologic therapy. Two lead SNPs (rs192705221 and rs72925168) were found to be associated with paradoxical eczema. Additionally, polygenic risk scores for atopic eczema and general atopic disease were also associated with paradoxical eczema. These findings indicate that atopic genetic burden contributes to the occurrence of paradoxical eczema in psoriasis patients receiving biologic therapy, suggesting shared underlying mechanisms. Incorporating genetic risk may improve treatment outcome prediction models for psoriasis.
JOURNAL OF INVESTIGATIVE DERMATOLOGY
(2023)
Article
Dermatology
Kristian Reich, Jonathan I. Silverberg, Kim A. Papp, Mette Deleuran, Norito Katoh, Bruce Strober, Lisa A. Beck, Marjolein de Bruin-Weller, Thomas Werfel, Fan Zhang, Pinaki Biswas, Marco D. DiBonaventura, Gary Chan, Susan Johnson, Saleem A. Farooqui, Urs Kerkmann, Claire Clibborn
Summary: This study evaluated the efficacy and safety of long-term abrocitinib treatment for patients with moderate-to-severe atopic dermatitis (AD) for up to 48 weeks. The results showed that abrocitinib treatment significantly improved skin symptoms and pruritus, with a manageable safety profile. This has important clinical implications for long-term treatment of chronic AD.
JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY
(2023)
Article
Dermatology
K. Reich, J. I. Silverberg, K. A. Papp, M. Deleuran, N. Katoh, B. Strober, L. A. Beck, M. de Bruin-Weller, T. Werfel, F. Zhang, P. Biswas, M. D. DiBonaventura, G. Chan, S. A. Farooqui, U. Kerkmann, C. Clibborn
Summary: Long-term treatment with abrocitinib significantly improves symptoms and quality of life in patients with moderate-to-severe atopic dermatitis.
JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY
(2023)
Article
Medicine, Research & Experimental
Teresa Tsakok, Jake Saklatvala, Theo Rispens, Floris C. Loeff, Annick de Vries, Michael H. Allen, Ines A. Barbosa, David Baudry, Tejus Dasandi, Michael Duckworth, Freya Meynell, Alice Russell, Anna Chapman, Sandy McBride, Kevin McKenna, Gayathri Perera, Helen Ramsay, Raakhee Ramesh, Kathleen Sands, Alexa Shipman, A. David Burden, Christopher E. M. Griffiths, Nick J. Reynolds, Richard B. Warren, Satveer Mahil, Jonathan Barker, Nick Dand, Catherine Smith, Michael A. Simpson
Summary: This study aimed to identify genetic variants contributing to the development of antidrug antibodies (ADA) against adalimumab, a widely used biologic in immune-mediated diseases. The study found a genome-wide association with ADA against adalimumab within the major histocompatibility complex (MHC) in psoriasis patients. The association was linked to specific amino acid residues in the HLA-DR peptide-binding groove, which conferred protection against ADA and treatment failure.
Article
Rheumatology
Lars E. Kristensen, Bruce Strober, Denis Poddubnyy, Ying-Ying Leung, Hyejin Jo, Kenneth Kwok, Ivana Vranic, Dona L. Fleishaker, Lara Fallon, Arne Yndestad, Dafna D. Gladman
Summary: This study analyzed the association between baseline cardiovascular disease risk and the occurrence of major adverse cardiovascular events and malignancies in tofacitinib-treated patients with PsA and PsO. The results showed that patients with increased ASCVD risk and baseline metabolic syndrome had higher incidence rates for MACE and malignancies. It highlights the importance of assessing CV risk and enhancing cancer monitoring in patients with PsA and PsO.
THERAPEUTIC ADVANCES IN MUSCULOSKELETAL DISEASE
(2023)