Responses to Ixekizumab in Male and Female Patients with Psoriatic Arthritis: Results from Two Randomized, Phase 3 Clinical Trials

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 a...

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Published in:Rheumatology and therapy. 2022-06, Vol.9 (3), p.919-933
Main Authors: Eder, Lihi, Tony, Hans-Peter, Odhav, Satish, Agirregoikoa, Eva Galindez, Korkosz, Mariusz, Schwartzman, Sergio, Sprabery, Aubrey Trevelin, Gellett, Amanda M., Park, So Young, Bertram, Clinton C., Ogdie, Alexis
Format: Article
Language:English
Subjects:
Clinical trials
Family Medicine
Gender differences
General Practice
Internal Medicine
Medicine
Medicine & Public Health
Monoclonal antibodies
Original Research
Orthopedics
Psoriatic arthritis
Quality of Life Research
Remission (Medicine)
Response rates
Rheumatology
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Summary: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.
ISSN:2198-6576
2198-6584
DOI:10.1007/s40744-022-00445-w