PMID- 35496380
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220716
IS  - 2230-326X (Electronic)
IS  - 2230-326X (Linking)
VI  - 12
DP  - 2022
TI  - 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.
PG  - 53-61
LID - 10.2147/PTT.S357184 [doi]
AB  - 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.
CI  - (c) 2022 Viswanath et al.
FAU - Viswanath, Vishalakshi
AU  - Viswanath V
AUID- ORCID: 0000-0002-5873-2242
AD  - Department of Dermatology, Rajiv Gandhi Medical College, Thane, Mumbai, India.
FAU - Joshi, Pradnya
AU  - Joshi P
AD  - Department of Dermatology, Rajiv Gandhi Medical College, Thane, Mumbai, India.
FAU - Lawate, Prakash
AU  - Lawate P
AD  - Department of Dermatology, Rajiv Gandhi Medical College, Thane, Mumbai, India.
FAU - Tare, Dakshata
AU  - Tare D
AD  - Department of Dermatology, Rajiv Gandhi Medical College, Thane, Mumbai, India.
FAU - Dhoot, Dhiraj
AU  - Dhoot D
AUID- ORCID: 0000-0002-2045-9324
AD  - Department of Global Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, 
      Maharashtra, India.
FAU - Mahadkar, Namrata
AU  - Mahadkar N
AD  - Department of Global Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, 
      Maharashtra, India.
FAU - Barkate, Hanmant
AU  - Barkate H
AD  - Department of Global Medical Affairs, Glenmark Pharmaceuticals Ltd, Mumbai, 
      Maharashtra, India.
LA  - eng
PT  - Journal Article
DEP - 20220422
PL  - New Zealand
TA  - Psoriasis (Auckl)
JT  - Psoriasis (Auckland, N.Z.)
JID - 101709086
PMC - PMC9041601
OTO - NOTNLM
OT  - adverse events
OT  - apremilast
OT  - effectiveness
OT  - titration
COIS- Dr Dhiraj Dhoot, Dr Namrata Mahadkar and Dr Hanmant Barkate are employees of 
      Glenmark Pharmaceuticals Ltd. The other authors report no conflicts of interest 
      in this work.
EDAT- 2022/05/03 06:00
MHDA- 2022/05/03 06:01
PMCR- 2022/04/22
CRDT- 2022/05/02 06:50
PHST- 2022/01/14 00:00 [received]
PHST- 2022/03/17 00:00 [accepted]
PHST- 2022/05/02 06:50 [entrez]
PHST- 2022/05/03 06:00 [pubmed]
PHST- 2022/05/03 06:01 [medline]
PHST- 2022/04/22 00:00 [pmc-release]
AID - 357184 [pii]
AID - 10.2147/PTT.S357184 [doi]
PST - epublish
SO  - Psoriasis (Auckl). 2022 Apr 22;12:53-61. doi: 10.2147/PTT.S357184. eCollection 
      2022.