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.
Highlights
Psoriasis is a chronic, inflammatory, relapsing autoimmune disease of skin and joints having prevalence of 2% 3% in the world’s population [1]
In this study total 35 (9%) of patients were diagnosed with nail psoriasis while six subjects had psoriatic arthritis
Remarkable Psoriasis Area Severity Index (PASI) score improvement was observed in Tinefcon® treated psoriasis patients; PASI50 was attained in 52% of patients, PASI75 attained in 23% patients while PASI90 attained in 7% of patients after completion of the treatment
Summary
Inflammatory, relapsing autoimmune disease of skin and joints having prevalence of 2% 3% in the world’s population [1]. The most common form of psoriasis is plaque psoriasis affecting 80% - 90% of individuals suffering from psoriasis. Psoriasis is associated with other co-morbid disorders that include diabetes, dyslipidemia, obesity, hypertension and cardiovascular disease [3]. Treatment regimens available for psoriasis are topical therapy, phototherapy, systemic therapies, and biologics. Traditional topical therapy contains corticosteroids, tars, vitamin D and vitamin A analogs, and anthralin, but their use is limited to mild to moderate psoriasis [4]. Methotrexate and cyclosporine are preferred for the treatment of severe psoriasis as systemic agents but long-term treatment is associated with nephrotoxicity (cyclosporine) and hepatotoxicity (methotrexate). The long-term use of non-biologic treatment, psoralen-ultraviolet
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