COMPARISON OF EFFICACY OF METHOTREXATE VS APREMILAST IN MODERATE TO SEVERE PLAQUE PSORIASIS
Main Article Content
Keywords
Plaque psoriasis, Methotrexate, Apremilast, Efficacy
Abstract
Background and Aim: Psoriasis is a chronic relapsing skin condition that can significantly affect mental and physical well-being. Due to its persistence, the use of equally safe and effective medications as a long-term treatment is necessary. The current study aimed to analyze the efficacy of methotrexate and apremilast in the treatment of moderate to severe plaque psoriasis focusing on their effectiveness, safety, and patient satisfaction, at a Tertiary Care Hospital in Karachi.
Study Design: Randomized controlled trial
Materials and Methods: This randomized controlled trial was carried out on 60 cases of plaque psoriasis in the Department of Dermatology, Jinnah Postgraduate Medical Centre (JPMC), Karachi from March 2024 to August 2024. Patients aged 18-60 years of either gender with moderate to severe plaque psoriasis were enrolled and randomly allocated to two groups. Group I (n=30); were treated with methotrexate, given 7.5 mg once a week orally. Group II (n=30); were given apremilast with an initial oral dose of 10 mg and gradually increasing to 30mg twice daily. Each patient underwent careful history taking, general examination, and complete dermatological examination using the PASI score as a baseline evaluation test.
Results: Mean age of patients was 40.64±11.5 years. Among 60 patients, there were 27 (45%) male and 33 (55%) female. The mean age of group I and group II were 40.19±11.79 and 41.09±11.21 years, respectively. The mean value of disease duration in Group I and II was 2.9±0.9 years and 3.1±1.2 years, respectively. Mean Psoriasis Area and Severity Index (PASI) score of Group I and II at baseline, six weeks, twelve weeks (3 months), and Twenty-four weeks (6 months) follow up was 24.42±7.98 and 23.86±6.21, 20.46±6.76 and 19.34±5.48, 14.89±4.86 and 12.78±3.98, and 11.68±6.52 and 8.98±5.21, respectively. Apremilast showed more effective results in treating moderate to severe plaque psoriasis than Methotrexate. The percentage reduction of score in Group I and II was 52% and 58%, respectively. There were minimum adverse effects observed in both groups.
Conclusion: Our findings show that both drugs are effective in reducing the psoriasis severity in terms of Psoriasis Area Severity Index (PASI) score. Apremilast showed overall more effective improvement in PASI scores, indicating its better outcomes in terms of effectiveness and significantly better safety with fewer adverse effects as compared Methotrexate.
References
2. Evers AW, Verhoeven EW, Kraaimaat, FW. How stress gets under the skin: cortisol and stress reactivity in psoriasis. Br J Dermatol. 2018;163:986–91.
3. Tribo MJ, Turroja M, Castano-Vinyals G, Bulbena A, Ros E, Gracia-Martinez P, et al. Patients with moderate to severe psoriasis associate with higher risk of depression and anxiety symptoms: results of a multivariate study of 300 Spanish individuals with psoriasis. Acta Derm Venereol. 2019;99:1-5.
4. Griffiths C, Barker J, Bleaker T, Chalmers R, Ceamer D. Management of psoriasis and related disorders. Rooks textbook of Dermatology 9th edition. 2016; 35:22-29.
5. Gao JC, Wu AG, Contento MN, Maher JM, Cline A. Apremilast in the Treatment of Plaque Psoriasis: Differential Use in Psoriasis. Clin Cosmetic Invest Dermatol. 2022;15:395-402.
6. Ohtsuki M, Okubo Y, and Komine M. Apremilast, an oral phosphodiesterase 4 inhibitor, in the treatment of Japanese patients with moderate to severe plaque psoriasis: Efficacy, safety and tolerability results from a phase 2b randomized controlled trial. J Dermatol. 2017; 44(8):873–84.
7. Van Voorhees AS, Gold LS, Lebwohl M, Strober B, Lynde C, Tyring S, et al. Efficacy and safety of apremilast in patients with moderate to severe plaque psoriasis of the scalp: results of a phase 3b, multicenter, randomized, placebo-controlled, doubleblind study. J Am Academy Dermatol. 2020;83(1):96-103.
8. AbuHilal MD, Walsh S, Shear N. Use of apremilast in combination with other therapies for treatment of chronic plaque psoriasis: a retrospective study. J Cutaneous Med Surg. 2016;20(4):313-6.
9. Rosie TN, Khan AL, Khan MS, Yazdi QS, Karim AR. Efficacy and safety of apremilast versus methotrexate in the treatment of chronic plaque psoriasis. J Armed Forces Med Coll, Bangladesh. 2020;16(1):39-41.
10. Thai S, Zhuo J, Zhong Y, Xia Q, Chen X, et al. ,Real- world treatment patterns and healthcare costs in patients with psoriasis taking systemic oral or biologic therapies. J of Dermatol Treat. 2023 (Accepted author version posted online: 16 Feb 2023) DOI:10.1080/ 09546634.2023.2176708.
11. Srivastava D, Krishna A, David A. A comparative study of the efficacy of methotrexate versus methotrexate with apremilast in moderate to severe chronic plaque psoriasis. Indian J Dermatol 2023;68:393‑8
12. Shetty VH, Goel S, Babu AM, Eram H. A comparative study of the efficacy and safety of oral apremilast versus oral methotrexate in patients with moderate to severe chronic plaque psoriasis. Int J Res Dermatol 2018;4:563-9.
13. Afra TP, Razmi TM, Dogra S. Apremilast in psoriasis and beyond: Big hopes on a small molecule. Indian Dermatol Online J 2019;10:1-12.
14. Hassanandani T, Panda M, Jena AK, Raj C. 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;9:1-8.
15. Cohen BE, Martires KJ, Ho RS. Psoriasis and the risk of depression in the US population: National Health and Nutrition Examination survey 2009-2012. JAMA Dermatol.2016;152(1):73-79.8.Schafer PH,Parton
16. Velappan R,Venu S, Ramasamy S, Chellappan L. Current scenario in clinical trends of psoriasis in tertiary care hospital.Int J Res Dermatol 2019;5:452-6
17. Crowley J, Thaci D, Joly P, Peris K, Papp KA, Goncalves J, et al. Long-term safety and tolerability of apremilast in patients with psoriasis: Pooled safety analysis for >/=156 weeks from 2 phase 3, randomized, controlled trials (ESTEEM 1 and 2).J Am Acad Dermatol 2017;77:310-7.e1
18. Gisondi P, Giglio MD, Girolomoni G. Treatment Approaches to Moderate to Severe Psoriasis. International Journal of Molecular Sciences 2017; 18(11):24-7.
19. Ohtsuki M, Okubo Y, Komine M et al. Apremilast, an oral phosphodiesterase 4 inhibitor, in the treatment of Japanese patients with moderate to severe plaque psoriasis: Efficacy, safety and tolerability results from a phase 2b randomized controlled trial. J Dermatol 2017; 44(8):873–84.
20. Armstrong AW, Betts KA, Sundaram M et al. Comparative efficacy and incremental cost per responder of methotrexate versus apremilast for methotrexate-naïve patients with psoriasis. J Am Acad Dermatol 2016; 75(4):740-6.
21. Yan K, Zhang Y, Han L, Huang Q, Zhang Z, Fang X, et al. Safety and effcacy of methotrexate for Chinese adults with psoriasis with and without psoriatic arthritis. JAMA Dermatol. 2019;155:327-34.
22. Papp KA, Beyska‐Rizova S, Gantcheva ML, Slavcheva Simeonova E, Brezoev P, Celic M, Groppa L, Blicharski T, Selmanagic A, Kalicka‐Dudzik M, Calin CA. Efficacy and safety of piclidenoson in plaque psoriasis: Results from a randomized phase 3 clinical trial (COMFORT‐1). Journal of the European Academy of Dermatology and Venereology. 2024 ;38(6):1112-20.
23. Fiorillo L, Becker E, de Lucas R, Belloni-Fortina A, Armesto S, Elewski B, Maes P, Oberoi RK, Paris M, Zhang W, Zhang Z. Efficacy and safety of apremilast in pediatric patients with moderate-to-severe plaque psoriasis: 16-week results from SPROUT, a randomized controlled trial. Journal of the American Academy of Dermatology. 2024 1;90(6):1232-9.
24. Larson EL, DeMeo DP, Young AB, Margevicius S, Rutter J, Davies AL, Rohan CA, Korman NJ, Travers JB, McCormick TS, Cooper KD. Circulating Monocytes Are Predictive and Responsive in Moderate-to-Severe Plaque Psoriasis Subjects Treated with Apremilast. Journal of Investigative Dermatology. 2024 Feb 29.
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.
Muhammad Khurram
Department of Dermatology, Jinnah Postgraduate Medical Centre, Karachi Pakistan
Rabia Ghafoor
Department of Dermatology, Jinnah Postgraduate Medical Centre, Karachi Pakistan
Misbah Zari Qadir
Department of Dermatology, Jinnah Postgraduate Medical Centre, Karachi Pakistan
Kanwal Phulpoto
Department of Dermatology, Jinnah Postgraduate Medical Centre, Karachi Pakistan
Soonha Iqra
Department of Dermatology, Jinnah Postgraduate Medical Centre, Karachi Pakistan
Nazia Jabeen
Department of Dermatology, Jinnah Postgraduate Medical Centre, Karachi Pakistan
Ashraf Hussain
Department of Dermatology, Jinnah Postgraduate Medical Centre, Karachi Pakistan
Parisa Sanawar
Department of Dermatology, Jinnah Postgraduate Medical Centre, Karachi Pakistan