A COMPARATIVE study to evaluate efficacy and adverse effects of Oral Tofacitinib and Oral Methotrexate in Lichen Planus.

INTRODUCTION

Lichen planus is an idiopathic,inflammatory &  autoimmune mucocutaneous condition characterised by violaceous,polygonal,pruritic,flat topped,scaly papules & plaques commonly seen on flexural creases of body,lowerback,oral mucosa and also on scalp &nails.[1]It has a recurrent course and on healing leaves a post inflammatory hyper pigmentation and rarely scarring.[2]It is estimated to affect 0.5% to 2% of general population with no racial variation.Most common in middle aged adults with an female predominance.[2,3,4]

Despite the use of Multiple immunosuppressant drugs included oral corticosteroids,Treatment of Lichenplanus is challenging in view of frequent recurrences , repeated disease exacerbations and Possible adverse effects.

In this background to compare the efficacy and adverse effects of Older conventional drug  methotrexate with Newer immunomodulator drug Tofacitinib in Lichen planus.

  AIM AND OBJECTIVES

To study the efficacy and adverse effects of Oral Tofacitinib and Oral Methotrexate in  Lichen Planus.

DATA COLLECTION /SAMPLE METHODS :

• After taking informed consent,the patient’s Age,Sex,Address,Occupation and other demographic data will be noted.

• Detailed history regarding onset of disease, Disease duration,symptoms and any drug history will be taken.

• In all patients thorough dermatological examination will be performed taking note of the Type of skin lesions and distribution of lesions all over the body.

• Dermoscopy will be done to evaluate the diagnosis.

• Lab investigations like CBC, RFT,LFT, Viral screening and Mantoux test will be done in all patients.

• Patients will be divided into 2 Groups based on  sequence provided by statistician.

• Group A will be treated with Methotrexate 10mg (0.2mg/kg body weight) for 3 months.

• Group B will be treated with Tofacitinib 5mg BD for 3 months.

• At baseline, all patients’ photographic documentation will be done with patients consent and severity of the disease will be evaluated based on physician visual analog scale.

• At an interval of 4 weeks at each visit ,Photographic documentation will be taken with patients consent and patient satisfaction with the treatment will be assessed using Likert scale,while physicians evaluated the outcome using a visual analog scale.

• Final assessment will be done at  the end of 12 weeks,decrease in likert scale compared to baseline and decrease in physician visual analog scale compared to baseline will be calculated to know the efficacy of the treatment.

• Adverse effects if any will be noted at each review visit and final visit.

  STASTICAL ANALYSIS :

• A paired student’s t-test will be utilised to compare means before and after the treatment,while a student’s unpaired t-test will be employed to compare means between different procedures.
• For all statistical analysis p<0.05 will be considered as statistically significant.