ArticlePsoriasis (Auckland, N.Z.)2022
An Open-Label, Randomized, Prospective, Comparative, Three-Arm Clinical Trial to Evaluate the Safety and Effectiveness of Apremilast with Three Different Titration Methods in Patients with Chronic Plaque Psoriasis in India.
Article in Psoriasis (Auckland, N.Z.), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
1 citing paper in PubMed.
- Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.The Cochrane database of systematic reviews · 2023Review
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
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.
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