ABSTRACT
Purpose: To minimize adverse effects (AEs), apremilast is recommended to titrate at the initiation of therapy. But still, many patients experience AEs, resulting in discontinuation of therapy. As a result, many dermatologists have adapted to further titrate apremilast in different ways. The present study was planned to evaluate the safety and effectiveness of apremilast in different dose titration methods as initiation therapy in the treatment of plaque psoriasis. Patients and Methods: In this open-label, randomized, prospective, comparative, three-arm, single center study, 128 plaque psoriasis patients were included. Patients were randomized into three groups. Group I received standard titration for the first 6 days; Group II received all tablets in a starter pack as once a day (OD) total for 13 days; and Group III received two starter packs as 8 tablets each of apremilast 10 mg and 20 mg as OD and 10 tablets of 30 mg as OD, in total for 26 days. All groups received apremilast 30 mg as twice a day after initial titration. The total duration of apremilast therapy in all groups was 16 weeks. Results: In safety assessment, AEs were reported in 50%, 41.3% and 25% in Groups I, II and III, respectively (p <0.05) with nausea being the most common AE. In Group I, 10.53% of patients discontinued apremilast whereas 6.52% and 2.27% discontinued in Groups II and III respectively. Maximum number of AEs were seen in Group I in first week only (74.19%) compared with other groups. At week 16, on the Psoriasis Area and Severity Index, PASI 75 was achieved in 31.43%, 42.4% and 33.3% of patients in Groups I, II and III, respectively with no statistical difference between any groups. Conclusion: It can be concluded that slower titration is a useful strategy for minimizing AEs while at the same time maintaining effectiveness of apremilast.
Subject(s)
Lupus Erythematosus, Systemic , Skin Abnormalities , Diagnosis, Differential , Humans , Male , UlcerABSTRACT
CONTEXT: India accounts for 60% of the global leprosy burden. Deformities lead to a negative impact on the quality of life (QoL). There is a paucity of Indian studies evaluating the QoL in patients with leprosy. AIMS: This study was undertaken to assess QoL in leprosy patients with two different questionnaires, correlate QoL with demographic and clinical profile and evaluate the impact on health-related QoL scores. SETTINGS AND DESIGN: A cross-sectional study to evaluate the QoL was conducted in the dermatology OPD of a tertiary center in Maharashtra, India. MATERIALS AND METHODS: Demographic and clinical profile along with evaluation of QoL using DLQI and WHOQOL-BREF questionnaires was conducted in 60 leprosy patients. STATISTICAL ANALYSIS USED: Parametric test, R test, Chi-square test, Z test, Student's t-test (t), and Pearson's correlation coefficient (r) were used. RESULTS: The mean DLQI score was 8.4 ± 4.4 and 40% of patients had moderate impact on QoL, and the mean WHOQOL-BREF score was 3.13 ± 0.9. The demographic profile, type of leprosy and reactions did not have a statistically significant correlation with DLQI. Presence of deformity had significant impact on DLQI and a statistically significant impact on physical, psychological, and environmental domain in WHOQOL-BREF analysis. CONCLUSIONS: Deformities have a profound impact on QoL in leprosy patients on evaluation with DLQI and WHOQOL- BREF questionnaires. The social domain was least affected, whereas severe impact was noted in psychological domain. DLQI is a practical and simple questionnaire, whereas WHOQOL- BREF provides a comprehensive approach on all domains.
