PMID- 35754494
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220716
IS  - 1663-9812 (Print)
IS  - 1663-9812 (Electronic)
IS  - 1663-9812 (Linking)
VI  - 13
DP  - 2022
TI  - Post-Marketing Safety Concerns With Secukinumab: A Disproportionality Analysis of 
      the FDA Adverse Event Reporting System.
PG  - 862508
LID - 10.3389/fphar.2022.862508 [doi]
LID - 862508
AB  - Purpose: Secukinumab was approved for the treatment of psoriasis, psoriatic 
      arthritis, and ankylosing spondylitis. However, the long-term safety of 
      secukinumab in large sample population was unknown. The current study was to 
      evaluate the secukinumab-assocaited adverse events (AEs) through data mining of 
      the US Food and Drug Administration Adverse Event Reporting System (FAERS). 
      Methods: Reports in the FAERS from the first quarter of 2015 (FDA approval of 
      secukinumab) to the third quarter of 2021 were collected and analyzed. 
      Disproportionality analyses, including the reporting odds ratio (ROR), the 
      proportional reporting ratio (PRR), the Bayesian confidence propagation neural 
      network (BCPNN), and the multi-item gamma Poisson shrinker (MGPS) algorithms, 
      were employed in data mining to quantify the signals of secukinumab-related AEs. 
      Results: A total of 89,228 reports of secukinumab as the "primary suspected (PS)" 
      and 254,886 AEs induced by secukinumab were identified. Secukinumab-induced AE 
      occurrence targeted 27 system organ classes (SOCs). A total of 257 signals of 
      secukinumab-induced AEs in 19 SOCs were detected after conforming to the four 
      algorithms simultaneously. Common significant signals of infections, respiratory 
      disorders, skin and subcutaneous tissue disorders, immune system disorders, and 
      ear and labyrinth disorders have emerged. Unexpected significant AEs such as 
      injection site pain, vessel puncture site haemorrhage, arthralgia, hypokinesia, 
      Bell's palsy, parotid gland enlargement, and stress might also occur. The median 
      onset time of secukinumab-associated AEs was 56 days (interquartile range [IQR] 
      5-214 days), and most of the onsets occurred within the first 1, 2, 3, and 
      4 months after initiation of secukinumab. Conclusion: Our study found potential 
      new AE signals and provided a broader understanding of secukinumab's safety 
      profiles, supporting its rational use in chronic systemic inflammatory diseases.
CI  - Copyright (c) 2022 Shu, Ding, Liu, Wu, He and Zhang.
FAU - Shu, Yamin
AU  - Shu Y
AD  - Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, China.
FAU - Ding, Yufeng
AU  - Ding Y
AD  - Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, China.
FAU - Liu, Yanxin
AU  - Liu Y
AD  - Department of Pharmacy, Pengzhou People's Hospital, Pengzhou, China.
FAU - Wu, Pan
AU  - Wu P
AD  - Department of Pharmacy, Qionglai Maternal and Child Health and Family Planning 
      Service Center, Qionglai, China.
FAU - He, Xucheng
AU  - He X
AD  - Department of Pharmacy, Pengzhou Second People's Hospital, Pengzhou, China.
FAU - Zhang, Qilin
AU  - Zhang Q
AD  - Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, China.
LA  - eng
PT  - Journal Article
DEP - 20220608
PL  - Switzerland
TA  - Front Pharmacol
JT  - Frontiers in pharmacology
JID - 101548923
PMC - PMC9214234
OTO - NOTNLM
OT  - FAERS
OT  - adverse event
OT  - data mining
OT  - pharmacovigilance
OT  - secukinumab
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2022/06/28 06:00
MHDA- 2022/06/28 06:01
PMCR- 2022/06/08
CRDT- 2022/06/27 03:35
PHST- 2022/01/26 00:00 [received]
PHST- 2022/05/04 00:00 [accepted]
PHST- 2022/06/27 03:35 [entrez]
PHST- 2022/06/28 06:00 [pubmed]
PHST- 2022/06/28 06:01 [medline]
PHST- 2022/06/08 00:00 [pmc-release]
AID - 862508 [pii]
AID - 10.3389/fphar.2022.862508 [doi]
PST - epublish
SO  - Front Pharmacol. 2022 Jun 8;13:862508. doi: 10.3389/fphar.2022.862508. 
      eCollection 2022.