Evaluation of the Efficacy and Safety of Apremilast in the Management of Lichen Planus

Vishalakshi Viswanath,1 Pradnya Joshi,1 Mayuri Dhakne,1 Dhiraj Dhoot,2 Namrata Mahadkar,2 Hanmant Barkate2 1Department of Dermatology, Rajiv Gandhi Medical College, Thane, Maharashtra, India; 2Global Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, Maharashtra, IndiaCorrespondence: Namrata Mahadkar, Email [email protected]: Lichen planus is a chronic disease with often disappointing and less than optimal treatment options. Apremilast modulates inflammatory signalling pathways which play a central role in the pathogenesis of lichen planus, thus making it useful in the management of such patients.Materials and Methods: The present study was an investigator-initiated, single-centre, non-randomized, open-label, pilot study of the efficacy and safety of Apremilast in the treatment of lichen planus. All the patients were prescribed Apremilast 30mg, twice daily, for 12 weeks. Patients were evaluated for improvement in their lesions, based on the physician’s global assessment (PGA), subject global assessment (SGA), and target area lesion symptom score (TALSS).Results: A total of 34 patients were included in the study; 26 patients completed the study duration and were considered for the final analysis. After 12 weeks, 34.61% (n = 9/26) patients showed 2 or more grade improvement in their disease as per PGA. About 42.30% (n = 11/26) patients achieved more than 50% improvement in their lesions based on the subject global assessment of their disease. There was a significant improvement in TALSS during the study period (p < 0.0001). Only 23.07% (n = 6/26) patients developed one or more adverse events because of Apremilast with headache being the commonest side effect.Conclusion: The results obtained in our study justify that Apremilast is efficacious and safe in the management of patients with lichen planus. Based on these results, Apremilast can be considered as a promising alternative treatment option in patients with lichen planus.Keywords: Apremilast, lichen planus, efficacy, safet

Patient Satisfaction and Sensory Attributes of Nasal Spray Treatments of Olopatadine Hydrochloride/Mometasone Furoate Monohydrate and Azelastine Hydrochloride/Fluticasone Propionate for Allergic Rhinitis in Australia &ndash; An Observational Real-World Clinical Study

Simon Fifer,1 Lili Toh,1 Hanmant Barkate,2 Vineet Aggarwal,2 Dhammraj Borade,2 Roger Hereward Gordonsmith,3 Wen Wu,3 Claire Morgan,4 Katherine Young4 1Community and Patient Preference Research (CaPPRe) Pty Ltd, Sydney, New South Wales, Australia; 2Global Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, Maharashtra, India; 3Global Medical Affairs, Glenmark Pharmaceuticals Europe Ltd, Watford, Hertfordshire, UK; 4Medical Affairs, Seqirus (Australia) Pty Ltd, Melbourne, Victoria, AustraliaCorrespondence: Simon Fifer, Community and Patient Preference Research (CaPPRe), Level 20, 25 Bligh Street, Sydney, New South Wales, 2000, Australia, Tel +61 403 862 091, Email [email protected]: Combination intranasal corticosteroid and antihistamine sprays are a first-line treatment option for allergic rhinitis (AR), of which Azelastine Hydrochloride and Fluticasone Propionate nasal spray (AZE/FLU; Dymista®), and Olopatadine Hydrochloride and Mometasone Furoate Monohydrate nasal spray (OLO/MOM; Ryaltris®) are currently registered in Australia. As it is not known how patients value treatment attributes of current combination nasal sprays, this observational, real-world clinical study aimed to understand patients’ satisfaction with, and importance of, treatment attributes of OLO/MOM and AZE/FLU using an Anchored Best-Worst Scaling (ABWS) exercise.Participants and Methods: Four hundred and twenty-six adults in Australia with moderate to severe AR using either OLO/MOM or AZE/FLU completed an online survey incorporating an ABWS with 11 domains: 7 sensory (immediate taste of medication, aftertaste of medication, smell of medication, irritation to your nose, urge to sneeze, dripping out your nose/down your throat, dryness of your nose/throat) and 4 treatment-related (convenience, fast acting, duration of effect, and AR symptom control). The ABWS involved rescaling individual BWS scores using anchored ratings (0– 10) for most and least satisfied/important domains to create a total satisfaction index (TSI) (0– 100) to be compared across groups. Statistical comparisons were completed using ANOVA (TSI) and MANOVA (individual domains).Results: Participants using OLO/MOM (M = 68.26, SE = 1.39) had significantly higher TSI than participants using AZE/FLU (M=62.78, SE = 0.70) (p < 0.001), significantly higher satisfaction on 7 of 11 domains and regarded 8 of 11 domains as significantly more important compared to participants using AZE/FLU (all p < 0.05). Preferred domains were predominantly sensory attributes.Conclusion: Current findings showed that participants using OLO/MOM were more satisfied with their overall treatment compared to participants using AZE/FLU, particularly with sensory attributes, thus highlighting the suitability of OLO/MOM for people with AR who value sensory attributes. Prescribers of AR treatments are encouraged to discuss treatment attributes with patients to facilitate shared decision-making.Keywords: hay fever, patient preference, treatment satisfaction, best-worst scalin

Comparative Efficacy of Super Bioavailable Itraconazole Capsules 50 mg vs 65 mg Twice Daily in the Management of Glabrous Tinea

Bela Shah,1 Deval Mistry,2 Dharmender Jairam,1 Kajal Kansara,1 Rutvi Pandya,1 Presha Vasani,1 Dhiraj Dhoot,3 Namrata Mahadkar,3 Sumit Bhushan,3 Hanmant Barkate3 1Department of Dermatology, B J Medical College, Civil Hospital, Ahmedabad, Gujarat, India; 2Mistry Skin Clinic, Ahmedabad, Gujarat, India; 3Department of Global Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, Maharashtra, IndiaCorrespondence: Dhiraj Dhoot, Glenmark Pharmaceuticals Ltd., B D Sawant Marg, Near Bisleri Plant, Chakala, Andheri (E), Mumbai, 400099, India, Tel +919619811219, Email [email protected]: Owing to pharmacokinetic challenges of itraconazole, super-bioavailable itraconazole (SB) was developed and recently approved in strengths of 50mg and 65mg. But comparative study was lacking between these two strengths in glabrous tinea (dermatophytosis) management. Hence, this study was planned to compare the efficacy of both these strengths in dermatophytosis.Methods: One hundred eligible patients were enrolled in this prospective, randomized, clinical study during May-2022 to September-2022 at tertiary hospital in Ahmedabad in adults. Efficacy and safety assessments were done at week-3 and 6 with follow up at week-10 for relapse. Primary objective was to assess the proportion of patients achieving complete cure at week-6 following treatment in both the groups. Secondary outcomes compared safety, clinical and mycological cure rates.Results: Of the 100 patients enrolled, 98 patients (50 in SB-50mg and 48 in SB-65mg group) included in the final analysis. At week 6, 20 patients (40%) and 30 patients (62.5%) achieved complete cure (p < 0.05) in SB-50mg and SB-65mg groups, respectively. In completely cured patients, relapse was reported in 3 (15%) and 5 (17%) patients of SB-50mg and SB-65mg groups, respectively (p = 1). A significant difference was noted in clearance of symptoms and lesions in SB-65mg group (p < 0.05). Moreover, similar results were also obtained in sub-group analysis of recalcitrant dermatophytosis. Both the treatments were found to be safe and well tolerated with no discontinuation.Conclusion: Study result concluded the superiority of SB-65mg over SB-50mg in terms of cure rate and resolution of symptoms in dermatophytosis management.Keywords: comparison, dermatophytosis, efficacy, super-bioavailable itraconazole, 50mg, 65m

Surface decontamination treatments for improving the safety of meat and poultry

The microbiological safety of raw beef and poultry products continue to be one of the major concerns of the meat industry. In 2011, an estimated 9.4 million illnesses, 55,961 hospitalizations, and 1,351 deaths were attributed to known foodborne pathogens in the USA including Norovirus caused the most illnesses; nontyphoidal Salmonella spp., norovirus, Campylobacter spp., and Toxoplasma gondii caused the most hospitalizations; and nontyphoidal Salmonella spp., T. gondii, Listeriamonocytogenes, and norovirus caused the most deaths [Scallan et al. (Emerg Infect Dis 17:7–15, 2011)]. Several factors influence the incidence of pathogens in the meat and poultry food supply, some of the more important factors are livestock production practices that may inadvertently foster pathogen contamination; the emergence of “new” and antibiotic-resistant pathogens in the environment; increased manipulation and handling and accelerated processing of carcasses and raw materials; modification of traditional processing practices and greater complexity of manufacturing procedures and equipment; a more complex distribution and food preparation system that increases the risk of foodborne disease; more discriminate and selective pathogen detection methods to improve confirmation and trace-back of contaminated product; and consumer habits that represent inappropriate food handling and preparation practices [Keeton and Eddy (Preharvest and postharvest food safety—contemporary issues and future directions. Blackwell, Ames, 2004)]. The surface decontamination treatments of meat and poultry could improve the safety of these products and help to reduce foodborne illnesses. Details of some surface decontamination treatments of raw meat and poultry are discussed in this review. © 2014, Springer Science+Business Media New York

Rapid prototyping-assisted maxillofacial reconstruction

© 2015 Informa UK, Ltd. Rapid prototyping (RP) technologies have found many uses in dentistry, and especially oral and maxillofacial surgery, due to its ability to promote product development while at the same time reducing cost and depositing a part of any degree of complexity theoretically. This paper provides an overview of RP technologies for maxillofacial reconstruction covering both fundamentals and applications of the technologies. Key fundamentals of RP technologies involving the history, characteristics, and principles are reviewed. A number of RP applications to the main fields of oral and maxillofacial surgery, including restoration of maxillofacial deformities and defects, reduction of functional bone tissues, correction of dento-maxillofacial deformities, and fabrication of maxillofacial prostheses, are discussed. The most remarkable challenges for development of RP-assisted maxillofacial surgery and promising solutions are also elaborated