Methotrexate monotherapy versus methotrexate and apremilast combination therapy in the treatment of palmoplantar psoriasis: A prospective, randomised, assessor-blinded, comparative study
Open Access
- 30 June 2022
- journal article
- research article
- Published by Scientific Scholar in Indian Journal of Dermatology, Venereology and Leprology
- Vol. 89 (2), 213-220
- https://doi.org/10.25259/ijdvl_843_2021
Abstract
Background Palmoplantar psoriasis is a chronic debilitating condition which significantly impairs quality of life. Objectives To assess the efficacy and safety of the combination of apremilast and methotrexate compared with methotrexate monotherapy in the treatment of palmoplantar psoriasis. Also, to study the impact on treatment on the Dermatology Life Quality Index and Palmoplantar Quality of Life Index. Methods A total of 64 patients were randomised to two groups in a 1:1 ratio - Group A received both methotrexate and apremilast in combination, while Group B received only methotrexate, for 16 weeks. The primary endpoints were the mean score of Modified Palmoplantar Psoriasis Area and Severity Index at week 16, the proportion of patients achieving modified palmoplantar psoriasis area severity index-75 and/or Palmoplantar Psoriasis Physician Global Assessment score 0/1 at week 16. Results A significantly higher proportion of patients in Group A achieved Modified Palmoplantar Psoriasis Area and Severity Index-75 at week 16 (43% in Group A vs 30% in Group B). The Modified Palmoplantar Psoriasis Area and Severity Index score was significantly lower in the combination group at week 16 (4.03 ± 2.05 in Group A and 5.89 ± 2.31 in Group B, P-value = 0.002). About 80% of patients in the combination group with baseline Palmoplantar Psoriasis Physician Global Assessment ≥3 achieved Palmoplantar Psoriasis Physician Global Assessment 0/1 compared to 60% in Group B. The combination group showed a significantly higher reduction in Dermatology Life Quality Index and Palmoplantar Quality of Life Index scores compared to the methotrexate alone group (P-value = 0.025). No notable adverse events were observed. Limitation The limitations of the study were single blinding, small sample size and a lack of longer follow up to assess the rate of relapse. We did not account for attrition during sample size calculation. Also, due to the paucity of data regarding the use of apremilast in palmoplantar psoriasis, definitive comparisons could not be made with previous studies. Conclusion The combination of apremilast and methotrexate has superior efficacy and a similar safety profile as compared to methotrexate monotherapy for the treatment of moderate to severe palmoplantar psoriasis.Keywords
This publication has 18 references indexed in Scilit:
- The pharmacokinetic effect of coadministration of apremilast and methotrexate in individuals with rheumatoid arthritis and psoriatic arthritisClinical Pharmacology in Drug Development, 2014
- Efficacy and safety of systemic methotrexate vs. acitretin in psoriasis patients with significant palmoplantar involvement: a prospective, randomized studyJournal of the European Academy of Dermatology and Venereology, 2012
- Treatment of palmoplantar psoriasis with infliximab: a randomized, double‐blind placebo‐controlled studyJournal of the European Academy of Dermatology and Venereology, 2011
- Pattern and prevalence of physiological cutaneous changes in pregnancy: A study of 2000 antenatal womenIndian Journal of Dermatology, Venereology and Leprology, 2011
- Comparative therapeutic evaluation of different topicals and narrow band ultraviolet B therapy combined with systemic methotrexate in the treatment of palmoplantar psoriasisIndian Journal of Dermatology, 2011
- THERAPEUTIC HOTLINE: Alefacept in the treatment of hyperkeratotic palmoplantar psoriasisDermatologic Therapy, 2010
- Palmoplantar psoriasis: A phenotypical and clinical review with introduction of a new quality-of-life assessment toolJournal of the American Academy of Dermatology, 2009
- A retrospective analysis of treatment responses of palmoplantar psoriasis in 114 patientsJournal of the European Academy of Dermatology and Venereology, 2009
- Reduced Adiposity and High-Fat Diet-Induced Adipose Inflammation in Mice Deficient for Phosphodiesterase 4BEndocrinology, 2009
- Cyclic AMP-Specific Phosphodiesterase 4 Inhibitors Promote ABCA1 Expression and Cholesterol EffluxBiochemical and Biophysical Research Communications, 2002