COMPARISON OF SAFETY AND EFFICACY OF ORAL PIOGLITAZONE VERSUS ORAL METHOTREXATE IN THE MANAGEMENT OF PATIENTS WITH PLAQUE-TYPE PSORIASIS: A RANDOMIZED CONTROL STUDY
Main Article Content
Keywords
Plaque-type psoriasis, Methotrexate, Pioglitazone, Psoriasis Area and Severity Index (PASI), Adverse reactions
Abstract
Background: Psoriasis is a chronic, immune-mediated inflammatory skin disorder affecting quality of life. Plaque-type psoriasis, its most common form, requires long-term management balancing efficacy and safety. Methotrexate, while effective, presents risks such as hepatotoxicity and hematological side effects. Pioglitazone, a thiazolidinedione, has shown potential as a safer alternative, but evidence remains inconclusive. Thus, the study aimed to compare the safety and efficacy of oral Pioglitazone versus oral Methotrexate in patients with plaque-type psoriasis.
Materials & Methods: The study was conducted on plaque psoriasis patients at Hassan Institute of Medical Sciences. It followed an open-label randomized control design with 34 participants, split into two groups of 17 each. Group 1 received Methotrexate (7.5 mg) weekly with folic acid, while Group 2 received Pioglitazone (30 mg) daily. PASI scores were measured at baseline and reassessed at weeks 4, 8, and 12. Appropriate tests were performed to assess potential adverse events.
Results: Methotrexate patients had a mean age of 56.12 years versus 50.76 years for pioglitazone (p = 0.177). Both groups had similar gender distributions (p = 0.697), illness duration (p = 0.914), and nail involvement (p = 0.486). Baseline PASI scores were 15.36 for methotrexate and 14.32 for pioglitazone, decreasing to 5.42 and 6.32 respectively by week 12 (p = 0.033). Methotrexate showed a 68.15% PASI improvement, while pioglitazone had 57.03% (p = 0.021). Six patients in the methotrexate group experienced adverse effects, compared to only three in the pioglitazone group (p = 0.117).
Conclusion: Although methotrexate demonstrated superior efficacy in treating plaque-type psoriasis compared to pioglitazone, the pioglitazone group had a lower incidence of side effects. However, the difference in the adverse effect profiles between the two groups was not statistically significant.
References
2. Abidi A, Rizvi D, Saxena K, et al.: The evaluation of efficacy and safety of methotrexate and pioglitazone in psoriasis patients: A randomized, open-labeled, active-controlled clinical trial. Indian J. Pharm. 2020 Jan; 52(1): 16–22.
3. Hassanandani T, Panda M, Jena AK, et al.: Methotrexate monotherapy versus methotrexate and apremilast combination therapy in the treatment of palmoplantar psoriasis: A prospective, randomised, assessor-blinded, comparative study. Indian J. Dermatol. Venereol. Leprol. 2022; 89(2):213–220.
4. Ghiasi M, Ebrahimi S, Lajevardi V, et al.: Efficacy and safety of pioglitazone plus phototherapy versus phototherapy in patients with plaque type psoriasis: a Double Blinded Randomized Controlled Trial. J. Dermatolog. Treat. 2019; 30(7): 664–667.
5. Arora S, Das P and Arora G (2021) Systematic Review and Recommendations to Combine Newer Therapies With Conventional Therapy in Psoriatic Disease. Front. Med. 8:696597. doi: 10.3389/fmed.2021.696597
6. Nedelcu RI, Balaban M, Turcu G, Brinzea A, Ion DA, Antohe M, Hodorogea A, Calinescu A, Badarau AI, Popp CG, Cioplea M, Nichita L, Popescu S, Diaconu C, Bleotu C, Pirici D, Popescu R, Popescu CM, Zurac SA. Efficacy of methotrexate as anti-inflammatory and anti-proliferative drug in dermatology: Three case reports. Exp Ther Med. 2019 Aug;18(2):905-910. doi: 10.3892/etm.2019.7511. Epub 2019 Apr 19. PMID: 31384322; PMCID: PMC6639959.
7. Lajevardi V, Hallaji Z, Daklan S, Abedini R, Goodarzi A, Abdolreza M. The efficacy of methotrexate plus pioglitazone vs. methotrexate alone in the management of patients with plaque-type psoriasis: a single-blinded randomized controlled trial. Int J Dermatol. 2015 Jan;54(1):95-101. doi: 10.1111/ijd.12585. Epub 2014 Sep 10. PMID: 25209868.
8. D., S., Bhandare, B., V., S., & Krishnan, P. (2017). A study to compare the efficacy of methotrexate alone vs. methotrexate plus pioglitazone in the management of plaque-type psoriasis. International Journal of Basic & Clinical Pharmacology, 6(4), 859–863. https://doi.org/10.18203/2319-2003.ijbcp20171093
9. Strober BE, Crowley JJ. Therapeutic options in the treatment of psoriasis. UpToDate. 2020. Available from: https://www.uptodate.com.
10. Agarwal S, Rengarajan S, Shivaprakash MR. Pioglitazone in psoriasis: current evidence and future perspective. Dermatol Ther (Heidelb). 2018 Sep;8(4):473-86.
11. Ogawa K, Honda T, Hatano Y, et al. Pioglitazone: A promising alternative in treating psoriasis in patients with metabolic syndrome. J Dermatol Sci. 2021 May;102(2):104-11.
12. Dogra S, Yadav S. Psoriasis in India: Prevalence and pattern. Indian J Dermatol Venereol Leprol 2010;76:595-601
13. Canal-García E, Bosch-Amate X, Belinchón I, Puig L. [Translated article] nail psoriasis. Actas dermo-sifiliograficas. 2022 May 1;113(5):T481-90.
14. Drateln, C.R. & Mercado, C.R. & Martínez, N. & Martínez-Abundis, Esperanza & Ortiz, M. & Cervantes, J.A. & Salazar, E. (2015). Efficacy of pioglitazone versus methotrexate in the treatment of psoriasis moderate-severe. Medicina Cutanea Ibero-Latino-Americana. 43. 122-124.
15. Shafiq N, Malhotra S, Pandhi P, et al. Pilot trial: Pioglitazone versus placebo in patients with plaque psoriasis (the P6). Int J Dermatol 2005;44:328–33.
16. Singh S, Bhansali A. Randomized placebo control study of insulin sensitizers (Metformin and Pioglitazone) in psoriasis patients with metabolic syndrome (Topical Treatment Cohort). BMC Dermatol 2016;16:12.
17. Czarnecka-Operacz M, Sadowska-Przytocka A. The possibilities and principles of methotrexate treatment of psoriasis - the updated knowledge. Postepy Dermatol Alergol. 2014 Dec;31(6):392-400. doi: 10.5114/pdia.2014.47121.
18. Chen P, Chen X, Lei L, Zhang Y, Xiang J, Zhou J, Lv J. The efficacy and safety of pioglitazone in psoriasis vulgaris: A meta-analysis of randomized controlled trials. Medicine. 2020 Aug 7;99(32):e21549.
Article Sidebar
Article Details
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
All articles published in JPTCP are licensed under Copyright Creative Commons Attribution-NonCommercial 4.0 International License.
Dr. Varshita Suresh Mendon
Department of Dermatology, Venereology and Leprosy, Hassan Institute of Medical Sciences, Hassan
Dr. Vinay. K.N
Assistant professor at Department of Dermatology, Venereology and Leprosy, Hassan Institute of Medical Sciences, Hassan
Dr. Suresh M.R
Associate professor and HOD at Department of Dermatology, Venereology and Leprosy, Hassan Institute of Medical Sciences, Hassan
Dr. Ravikumar B.C
Professor at Department of Dermatology, Venereology and Leprosy, Hassan Institute of Medical Sciences, Hassan
Dr. Vivekananda Ittigi
Senior Resident at Department of Dermatology, Venereology and Leprosy, Hassan Institute of Medical Sciences, Hassan
Dr. Umadevi H.R
Senior Resident at Department of Dermatology, Venereology and Leprosy, Hassan Institute of Medical Sciences, Hassan