POS0526 SEXUAL FUNCTION IN MALE AND FEMALE PATIENTS WITH RHEUMATOID ARTHRITIS: A POST-HOC ANALYSIS OF THE FINCH STUDIES
Background: While sexual function is impaired in a high proportion of patients with rheumatoid arthritis (RA), it is often neglected in patient care. 1 FINCH 1 ( NCT02889796 ), FINCH 2 ( NCT02873936 ) and FINCH 3 ( NCT02886728 ) were Phase 3 studies to assess the safety and efficacy of filgotinib (F...
Saved in:
| Published in | Annals of the rheumatic diseases Vol. 80; no. Suppl 1; pp. 496 - 497 |
|---|---|
| Main Authors | , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
01.06.2021
|
| Online Access | Get full text |
Cover
Loading…
| Summary: | Background:
While sexual function is impaired in a high proportion of patients with rheumatoid arthritis (RA), it is often neglected in patient care.
1
FINCH 1 (
NCT02889796
), FINCH 2 (
NCT02873936
) and FINCH 3 (
NCT02886728
) were Phase 3 studies to assess the safety and efficacy of filgotinib (FIL) for moderate-to-severe RA; patient-reported sexual function was also evaluated.
Objectives:
To analyse disease characteristics associated with sexual function and explore the effect of FIL and adalimumab (ADA) on sexual function in males and females in the FINCH studies.
Methods:
Post-hoc analyses included data from patients who were randomised and received ≥1 dose of study drug in the FINCH studies. Male and female subgroup analyses were performed to describe the correlation between baseline disease characteristics and baseline visual analogue scale (VAS) sexual function score (using Pearson correlation coefficient) and to assess the treatment effect on the change from baseline in VAS sexual function (mm) up to Week 52 (FINCH 1 and 3) or Week 24 (FINCH 2). Patients indicated how RA affected their ability to have sex during the last week using an exploratory 0–100 VAS (0: no effect; 100: complete inhibition). Changes from baseline were analysed with a mixed-effects model for repeated measures. All P values are nominal for exploratory purposes.
Results:
Baseline characteristics are shown in the Table 1. Univariate analyses revealed significant positive correlations (P<0.05) between disease duration and baseline VAS sexual function score in male and female subgroups in FINCH 1; no significant correlations were seen in male and female subgroups of FINCH 2 and 3. In all studies, significant correlations (P<0.05) were observed between baseline VAS sexual function score and baseline disease characteristics (swollen/tender joint count 28, Disease Activity Score-28, Health Assessment Questionnaire Disability Index, 36-Item Short Form Survey, patient global VAS, pain VAS or fatigue) in males or females. In all studies, analysis of least-squares mean changes from baseline in VAS sexual function revealed improvements in both males and females on FIL as early as Week 2, until Week 52 (Week 24 in FINCH 2). Figure 1 shows data for FINCH 1.
Conclusion:
Sexual function should be considered as an important patient outcome in RA treatment. At baseline in the FINCH studies, disease activity negatively impacted sexual function in both male and female patients. Active treatment with FIL or ADA resulted in early and sustained improvements from baseline in sexual function.
References:
[1]Tristano AG.
World J Orthop
2014;5:107–11
Table 1.
Mean (standard deviation) baseline characteristics
FINCH 1
FINCH 2
FINCH 3
Male n=258
Female n=990
Male
n=79
Female n=270
Male n=233
Female n=691
Duration of RA, yr
6.8 (7.38
)
8.0 (7.63
)
11.3 (8.53)
12.7 (9.35)
2.1 (5.35)
2.2 (4.85)
SJC28
11 (5.0
)
11 (5.1
)
13 (6.2
)
12 (6.1
)
11 (5.4
)
11 (5.7
)
TJC28
14 (6.5
)
15 (6.4
)
15 (7.5
)
16 (7.0
)
14 (6.6
)
15 (6.7
)
HAQ-DI
1.35 (0.614
)
1.64 (0.601
)
1.41 (0.689
)
1.73 (0.634
)
1.37 (0.651
)
1.62 (0.617
)
DAS28 (CRP)
5.6 (0.95
)
5.8 (0.90
)
5.8 (1.08
)
5.9 (0.92
)
5.7 (1.00
)
5.7 (0.99
)
SF-36 PCS
34.3 (7.72
)
33.0 (7.34
)
31.7 (8.48
)
30.9 (7.75
)
34.4 (7.72
)
33.4 (7.47
)
SF-36 MCS
45.9 (10.15
)
43.6 (10.65
)
43.7 (11.20
)
44.5 (11.71
)
46.2 (11.75
)
43.0 (10.89
)
FACIT-fatigue
30.0 (10.00
)
26.8 (10.49
)
26.3 (11.15
)
24.0 (11.64
)
30.7 (10.93
)
26.6 (10.89
)
Patient global VAS (mm)
64 (19.8
)
67 (19.0
)
66 (20.0
)
70 (19.5
)
65 (22.4
)
66 (20.3
)
Pain VAS (mm)
61 (20.6
)
66 (19.5
)
62 (22.3
)
68 (20.6
)
64 (22.3
)
66 (20.9
)
VAS sexual function score
44 (30.2)
49 (32.3)
48 (34.6)
49 (36.8)
42 (34.4)
48 (35.1)
Variables in bold significantly correlated with VAS sexual function score (P<0.05)
DAS28 (CRP), Disease Activity Score-28 using C-reactive protein; FACIT, Functional Assessment of Chronic Illness Therapy; HAQ-DI, Health Assessment Questionnaire Disability Index; MCS, mental component summary; PCS, physical component summary; RA, rheumatoid arthritis; SF-36, 36-Item Short Form Survey; S/TJC28, swollen/tender joint count based on 28 joints; VAS, visual analogue scale
Acknowledgements:
The FINCH studies were funded by Gilead Sciences, Inc (Foster City, CA, USA). Medical writing/editorial support was provided by Debbie Sherwood, BSc, CMPP (Aspire Scientific, Bollington, UK), funded by Galapagos NV (Mechelen, Belgium).
Disclosure of Interests:
Luis Fernando Perez-Garcia Consultant of: Galapagos, Grant/research support from: CONACYT, ReumaNederland, and ZonMw, Mihaela Micu Speakers bureau: AbbVie, Angelini, Eli Lilly, Ewopharma, Novartis, UCB, Consultant of: Galapagos, Lien Gheyle Shareholder of: Galapagos, Employee of: Galapagos, Zhaoyu Yin Shareholder of: Gilead, Employee of: Gilead, YingMeei Tan Shareholder of: Gilead, Employee of: Gilead, Kun Chen Shareholder of: Gilead, Employee of: Gilead, Patrick Papazian Speakers bureau: Amgen, Gilead, Janssen, MSD, Consultant of: Gilead, Janssen, MSD, Employee of: Galapagos, part-time employee since Sept 2020, Katrien Van Beneden Shareholder of: Galapagos, Employee of: Galapagos, Radboud Dolhain Speakers bureau: AbbVie, Genzyme, Novartis, Roche, UCB, Consultant of: Galapagos, Grant/research support from: UCB, Rene Westhovens Speakers bureau: Celltrion, Galapagos/Gilead, Consultant of: Celltrion, Galapagos/Gilead |
|---|---|
| ISSN: | 0003-4967 1468-2060 |
| DOI: | 10.1136/annrheumdis-2021-eular.1774 |