J Coll Physicians Surg Pak. 2025 Nov;35(11):1374-1379. doi: 10.29271/jcpsp.2025.11.1374.
ABSTRACT
OBJECTIVE: To compare the efficacy and safety of oral and subcutaneous (SC) routes of methotrexate (MTX) administration in patients with severe psoriasis in terms of the time taken to attain a Physician Global Assessment (PGA) score of 0 or 1.
STUDY DESIGN: Single-blinded randomised controlled trial. Place and Duration of the Study: Department of Pharmacology and Therapeutics, Army Medical College, in collaboration with Departments of Dermatology and Pathology, Pak Emirates Military Hospital, Rawalpindi, Pakistan, from January 2024 to January 2025.
METHODOLOGY: Patients of either gender aged between 18 and 65 years, diagnosed with severe psoriasis (PGA score of 4), were included. Patients were randomised by the lottery method into two equal groups, with 30 patients in each group. Group 1 (G-1) received oral MTX (10 to 25mg) once a week for 4 weeks, and Group 2 (G-2) received SC MTX (10 to 25mg) once a week for 4 weeks. Efficacy and safety were compared between the two groups at 0 and 4 weeks. The Chi-square and t-test were used for comparison among the groups.
RESULTS: A total of 60 patients with a median (IQR) age of 42.0 (27.0) years; 51 (85%) were males and 9 (15%) were females. The pre-treatment PGA score was 4, while after treatment, 14 (23.3%) patients had a score of 0, 23 (38.3%) had a score of 1, 17 (28.3%) had a score of 2, and 06 (10%) had a score of 3. Both groups showed effective improvement after the treatment, with statistically significant findings (p <0.001). The SC route in the G-2 showed a greater reduction in the PGA score compared to the oral route in the G-1. Corres- pondingly, the SC route of medicine is comparatively safer than the oral route by reporting less episodes of diarrhoea (76.7% vs. 3.3%) and vomiting (26.7% vs. 6.7%).
CONCLUSION: The SC route of MTX administration is safer and more effective than the oral route in patients with severe psoriasis.
KEY WORDS: Efficacy and safety of methotrexate, Methotrexate, Oral route, Psoriasis, Subcutaneous route.
PMID:41247674 | DOI:10.29271/jcpsp.2025.11.1374
