TITLE:
Efficacy and Safety of Tinefcon® Tablets in Subjects with Plaque Psoriasis: An Open Label, Non-Comparative, Multicenter, Phase IV Trial
AUTHORS:
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
KEYWORDS:
Psoriasis, Tinefcon® Tablet, Sphaeranthus indicus
JOURNAL NAME:
Journal of Cosmetics, Dermatological Sciences and Applications,
Vol.6 No.2,
April
25,
2016
ABSTRACT: Importance: This post-marketing surveillance study was conducted to
evaluate real-world information about the efficacy and safety of oral Tinefcon? 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? 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? 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? tablets showed good
efficacy and had a favorable safety profile in plaque psoriasis patients.