To study safety and efficacy of Methotrexate and Apremilast in the Management of Psoriasis: Therapeutic Outcomes and Adverse Effects

Research Design: Randomized controlled study

Research Setting:  Dermatology OPD and Pharmacology department GIMS Hospital, Greater Noida

Target Population:  Patients of moderate -severe psoriasis visiting Dermatology OPD.

Study Duration: 18 months

Sampling method: Eligible participants (i.e., patients diagnosed with moderate to severe chronic psoriasis who meet the inclusion/exclusion criteria) will be enrolled from the psoriasis clinic at Dept. of dermatology, GIMS, Greater Noida. Once enrolled, participants will be randomly allocated into two groups (Methotrexate and Apremilast) using a computer-generated randomization sequence to eliminate selection bias.

Methotrexate Group: The administration of Methotrexate begins with a test dose of 5 mg. After administering this test dose, a re-evaluation of CBC (Complete Blood Count), LFT (Liver Function Test), and KFT (Kidney Function Test) is performed after one week to assess tolerance and safety. On the 7th day, if the results are within acceptable limits, Methotrexate therapy is initiated with a dose of 0.3 mg/kg, with a maximum limit of 30 mg per week. The drug is then continued on a fixed day each week, with once-weekly administration. ³ Apremilast Group: Apremilast dosing is initiated with a titration schedule to reduce the risk of gastrointestinal side effects. On Day 1, the patient receives 10 mg once daily. For the next three days, 10 mg twice daily is administered. Then on Day 5, the dose is increased to 20 mg once daily, followed by 20 mg twice daily for the next three days. On Day 9, the patient receives 30 mg once daily, and from Day 10 onwards, the maintenance dose of 30 mg twice daily is continue