PMID- 35397092
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220716
IS  - 2198-6576 (Print)
IS  - 2198-6584 (Electronic)
IS  - 2198-6576 (Linking)
VI  - 9
IP  - 3
DP  - 2022 Jun
TI  - Responses to Ixekizumab in Male and Female Patients with Psoriatic Arthritis: 
      Results from Two Randomized, Phase 3 Clinical Trials.
PG  - 919-933
LID - 10.1007/s40744-022-00445-w [doi]
AB  - INTRODUCTION: Differences in psoriatic arthritis (PsA) treatment response between 
      sexes for ixekizumab, an interleukin-17A antagonist, are largely unexplored. This 
      analysis used data from randomized clinical trials (RCTs) evaluating ixekizumab 
      to study differences in treatment response between male and female patients with 
      PsA. METHODS: We used pooled data from patients enrolled in SPIRIT-P1 and 
      SPIRIT-P2 (NCT01695239 and NCT02349295, respectively), phase 3 RCTs evaluating 
      ixekizumab every 4 and 2 weeks in patients with active PsA. Subgroups of patients 
      were defined by sex (male, female). Efficacy was measured by the proportion of 
      male and female patients achieving American College of Rheumatology 20%/50%/70% 
      improvement criteria (ACR20/50/70), minimal disease activity or very low disease 
      activity (MDA/VLDA), and Disease Activity Index for Psoriatic Arthritis (DAPSA) 
      scores representing low disease activity (LDA) or remission through week 156. 
      Changes from baseline in components of the above measures were also assessed 
      through week 156. RESULTS: Compared to male patients at baseline, female patients 
      were older, had higher body mass index and lower C-reactive protein levels, and 
      had worse tender joint count, Health Assessment Questionnaire Disability Index, 
      and Leeds Enthesitis Index scores. Through week 156, female patients in all 
      treatment arms had lower response rates than male patients in all analyzed 
      composite measures (ACR20/50/70; MDA/VLDA; DAPSA LDA/remission), with significant 
      differences observed at multiple timepoints in both ixekizumab treatment arms. 
      Female patients also had smaller numeric changes from baseline in the composite 
      measures' individual components. CONCLUSION: Compared to female patients, male 
      patients had greater response rates in ACR20/50/70, MDA/VLDA, and DAPSA 
      LDA/remission and numerically larger improvements in these measures' individual 
      components, although clinical significance is unclear. Continued efforts to 
      understand sex differences in treatment response may provide insights that can 
      help optimize clinical decision making. TRIAL REGISTRATION: ClinicalTrials.gov 
      identifiers, NCT01695239 and NCT02349295.
CI  - (c) 2022. The Author(s).
FAU - Eder, Lihi
AU  - Eder L
AD  - Department of Medicine, Women's College Hospital, University of Toronto, 76 
      Grenville St, 6th Floor, Toronto, ON, Canada. Lihi.eder@wchospital.ca.
FAU - Tony, Hans-Peter
AU  - Tony HP
AD  - Rheumatology/Clinical Immunology, University Hospital of Wurzburg, Wurzburg, 
      Germany.
FAU - Odhav, Satish
AU  - Odhav S
AD  - Arthritis Clinic, Jackson, TN, USA.
FAU - Agirregoikoa, Eva Galindez
AU  - Agirregoikoa EG
AD  - Rheumatology Department, University Hospital Basurto, Bilbao, Spain.
FAU - Korkosz, Mariusz
AU  - Korkosz M
AD  - Jagiellonian University Medical College, Krakow, Poland.
FAU - Schwartzman, Sergio
AU  - Schwartzman S
AD  - The Hospital for Special Surgery, New York, NY, USA.
FAU - Sprabery, Aubrey Trevelin
AU  - Sprabery AT
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Gellett, Amanda M
AU  - Gellett AM
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Park, So Young
AU  - Park SY
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Bertram, Clinton C
AU  - Bertram CC
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Ogdie, Alexis
AU  - Ogdie A
AD  - Penn Medicine, Philadelphia, PA, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01695239
SI  - ClinicalTrials.gov/NCT02349295
PT  - Journal Article
DEP - 20220409
PL  - England
TA  - Rheumatol Ther
JT  - Rheumatology and therapy
JID - 101674543
PMC - PMC9127019
OTO - NOTNLM
OT  - Ixekizumab
OT  - Outcome measures
OT  - Psoriatic arthritis
OT  - Sex differences
OT  - Women's health
EDAT- 2022/04/10 06:00
MHDA- 2022/04/10 06:01
PMCR- 2022/04/09
CRDT- 2022/04/09 12:03
PHST- 2022/01/21 00:00 [received]
PHST- 2022/03/15 00:00 [accepted]
PHST- 2022/04/10 06:00 [pubmed]
PHST- 2022/04/10 06:01 [medline]
PHST- 2022/04/09 12:03 [entrez]
PHST- 2022/04/09 00:00 [pmc-release]
AID - 10.1007/s40744-022-00445-w [pii]
AID - 445 [pii]
AID - 10.1007/s40744-022-00445-w [doi]
PST - ppublish
SO  - Rheumatol Ther. 2022 Jun;9(3):919-933. doi: 10.1007/s40744-022-00445-w. Epub 2022 
      Apr 9.