摘要
Importance: This post-marketing surveillance study was conducted to evaluate real-world information about the efficacy and safety of oral Tinefcon<sup>?</sup> tablets (Sphaeranthus indicus based) in plaque psoriasis patients. Materials and Methods: Patients aged at least 18 years and older with clinical diagnosis of plaque psoriasis, were enrolled in this open label, non-comparative, multicenter trial. All eligible subjects received four 700 mg Tinefcon<sup>?</sup> tablets/day for 12 weeks. The primary outcome measure was percent change in Psoriasis Area Severity Index (PASI) score from baseline to week 12. The secondary outcome measures were Physician Global Assessment (PGA), Nail Psoriasis Severity Index (NAPSI), Psoriatic Arthritis Evaluation and Gene Expression Profiling and Immunohistochemistry. Results: After completion of Tinefcon<sup>?</sup> treatment at 12 weeks, more than half of subjects (52%) achieved PASI 50 response;PASI 75 response was attained in 68 (23%) subjects and PASI 90 response in 22 (7%) subjects. Five subjects with severe psoriasis achieved PASI 90 without receiving any concomitant medication. Reduction in severity as assessed by PGA was observed in more than half of patients with moderate disease. Histopathological evaluation revealed that epidermal thickness was considerably reduced in 66% of subjects. The expression of inflammatory marker S100A9 protein was(meaningfully reduced in 60% patients with non-significant reduction of Keratin 10 protein expression. Gene expression analysis showed increase down regulation of SERPINB4;PI3 and KRT16 genes after a 12-week treatment period in subjects with higher PASI scores. Conclusion: Oral Tinefcon<sup>?</sup> tablets showed good efficacy and had a favorable safety profile in plaque psoriasis patients.
Importance: This post-marketing surveillance study was conducted to evaluate real-world information about the efficacy and safety of oral Tinefcon<sup>?</sup> tablets (Sphaeranthus indicus based) in plaque psoriasis patients. Materials and Methods: Patients aged at least 18 years and older with clinical diagnosis of plaque psoriasis, were enrolled in this open label, non-comparative, multicenter trial. All eligible subjects received four 700 mg Tinefcon<sup>?</sup> tablets/day for 12 weeks. The primary outcome measure was percent change in Psoriasis Area Severity Index (PASI) score from baseline to week 12. The secondary outcome measures were Physician Global Assessment (PGA), Nail Psoriasis Severity Index (NAPSI), Psoriatic Arthritis Evaluation and Gene Expression Profiling and Immunohistochemistry. Results: After completion of Tinefcon<sup>?</sup> treatment at 12 weeks, more than half of subjects (52%) achieved PASI 50 response;PASI 75 response was attained in 68 (23%) subjects and PASI 90 response in 22 (7%) subjects. Five subjects with severe psoriasis achieved PASI 90 without receiving any concomitant medication. Reduction in severity as assessed by PGA was observed in more than half of patients with moderate disease. Histopathological evaluation revealed that epidermal thickness was considerably reduced in 66% of subjects. The expression of inflammatory marker S100A9 protein was(meaningfully reduced in 60% patients with non-significant reduction of Keratin 10 protein expression. Gene expression analysis showed increase down regulation of SERPINB4;PI3 and KRT16 genes after a 12-week treatment period in subjects with higher PASI scores. Conclusion: Oral Tinefcon<sup>?</sup> tablets showed good efficacy and had a favorable safety profile in plaque psoriasis patients.
作者
Somesh Sharma
Kailash Bhatia
Meetesh Agarwal
Sandesh Gupta
Leelavathi Budamakuntla
Sudhakar Grandhi
Vinod Titarmare
Sushil Pande
Ranjan Rawal
Aruna Samarth
Rizwan Haq
Vikrant Saoji
D. V. S. Pratap
L. M. Kansal
D. G. Saple
Shatrughan Sahay
Parag Kalyani
Puneet Goyal
Sharmila Patil
A. J. Kanwar
Bhavesh Swarnakar
Sujay Kulkarni
Abhijeet Morde
Hitesh Khandagale
Yogesh Dound
Nitin Jadhav
Sanjeev Hegde
Murlidhara Padigaru
Ashish C. Suthar
Somesh Sharma;Kailash Bhatia;Meetesh Agarwal;Sandesh Gupta;Leelavathi Budamakuntla;Sudhakar Grandhi;Vinod Titarmare;Sushil Pande;Ranjan Rawal;Aruna Samarth;Rizwan Haq;Vikrant Saoji;D. V. S. Pratap;L. M. Kansal;D. G. Saple;Shatrughan Sahay;Parag Kalyani;Puneet Goyal;Sharmila Patil;A. J. Kanwar;Bhavesh Swarnakar;Sujay Kulkarni;Abhijeet Morde;Hitesh Khandagale;Yogesh Dound;Nitin Jadhav;Sanjeev Hegde;Murlidhara Padigaru;Ashish C. Suthar(Piramal Enterprises Limited, Mumbai, India;Bhatia Skin Center, Bima Nagar, Indore, India;Agrawal Path LAB Vijaynagar, Indore, India;Skin & Laser Center, Krishna Nagar, New Delhi, India;Diabetes and Shirdi Skin Care Centre, Karnataka, India;Medipoint Hospitals Pvt. Ltd., Pentagon Research Pvt. Ltd., Pune, India;Skin Care Clinic, Nagpur, India;NKP Salve Institute and Lata Mangeshkar Hospital, Nagpur, India;Department of Dermatology, Sheth VS General Hospital, Ahmedabad, India;Sai Skin Care Clinic, Hyderabad, India;Radiance Skin Care Clinic, Nagpur, India;Dr. Vikrant Saoji’s Clinic, Ramdaspeth, Nagpur, India;Durgabai Deshmukh Hospital & Research Center, Hyderabad, India;Kansal Cosmetic & Skin Care Clinic, Jaipur, India;Dr. Saple’s Clinic, Dadar (East), Mumbai, India;Sri Skin Care & Laser Clinic, Lucknow, UP, India;Ruby Hall Clinic, Pune, India;Renova Skin & Laser Clinic, Sector-9, Mansarovar, Jaipur, India;Dr. D. Y. Patil Medical College and Hospital, Nerul, Navi Mumbai, India;Department of Dermatology, Venerology & Leprology, Postgraduate Institute of Medical Education and Research, Chandigarh, India;Swarnakar Superspeciality Centre, Indore, India;Clinical Research and Development, Piramal Enterprises Limited, Mumbai, India)
