Background/Purpose : The objective of this study was to evaluate the prevalence of sexual dysfunction and vaginal dryness in female patients with early, active primary Sjögren’s syndrome (pSS), and to explore the association with patient characteristics, symptoms, disease activity, and exocrine gland function.

Methods : Between September 2015 and May 2017,  52 female pSS patients were included in an RCT studying the efficacy and safety of abatacept (NCT02067910). Inclusion criteria were fulfilment of the AECG criteria, EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) ≥5, disease duration ≤7 years and positive salivary gland biopsy. The present analysis concerns data from the baseline visit. ESSDAI, unstimulated whole salivary flow (UWS), stimulated whole salivary flow (SWS), Schirmer’s test, ocular staining score (OSS), immunoglobulin G, and rheumatoid factor  were determined. Patients completed a questionnaire including the Female Sexual Function Index (FSFI), EULAR Sjögren Syndrome Patient Reported Index (ESSPRI), numeric rating scale (NRS, range 0-10) for vaginal, ocular and oral dryness, and EuroQol five dimensions questionnaire (EQ-5D). Patients who did not have intercourse due to lack of a sexual partner were excluded from analyses involving the FSFI, as this may cause low FSFI scores while no sexual dysfunctioning is present. Sexual dysfunction was defined as FSFI<26.55¹. Associations between FSFI, vaginal dryness and other clinical parameters were explored using Spearman’s correlation coefficient.

Results: Of the 52 included patients, 26 (50%) were premenopausal. Median vaginal dryness score was 6.0. 32 patients (62%) did not have intercourse in the past four weeks. Reasons for not having intercourse were low sexual desire (n=10), dyspareunia (n=7), lack of a sexual partner (n=7), vaginal dryness (n=4) and other (n=4). Median FSFI score was 14.4. Sexual dysfunction was present in 40 patients (89%). Sexual dysfunction was associated with age, vaginal dryness, and ESSPRI total and pain subdomain (table 1). Vaginal dryness was associated with age, ESSPRI total and dryness subdomain scores, and with ocular and oral dryness. In premenopausal patients, sexual dysfunction was associated with ESSPRI fatigue subdomain (ρ=-0.450, p=0.036) and MFI reduced activity (ρ -0.520, p=0.013). In postmenopausal patients, sexual dysfunction was associated with ESSPRI total (ρ=-0.426, p=0.043) and pain subdomain scores (ρ=-0.459, p=0.027), EQ-5D score (ρ=-0.500, p=0.015), and MFI reduced motivation (ρ=-0.611, p=0.002).

Conclusion: Sexual dysfunction and vaginal dryness are highly prevalent in female patients with early, active pSS, and should be included in the outcome measures of clinical trials. Sexual dysfunction and vaginal dryness are associated with symptoms of pSS in pre- and postmenopausal women, but not with systemic disease activity or salivary and tear gland function.

¹ Wiegel et al. J Sex Marital Ther 2005;31:1-20.