Seasonal Effect on Fatigue, Pain and Dryness in Primary Sjögren's Syndrome

Pierre-Marie Duret; Nicolas Meyer; Alain Saraux; Valérie Devauchelle-Pensec; Raphaele Seror; Véronique Le-Guern; Claire Larroche; Aleth Perdriger; Jean Sibilia; Vianney Guardiolle; Xavier Mariette; Jacques-Eric Gottenberg

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Arthritis Res Ther. 2020;22(39)

Abstract and Introduction

Abstract

Background: To assess the presence of a seasonal effect on fatigue, pain and dryness in primary Sjögren's syndrome (pSS).

Methods: Data (date; visual analogue scales (VAS) for pain, fatigue and dryness) were extracted from three randomised placebo-controlled trials (RCTs) evaluating infliximab (TRIPSS; n = 103 patients), hydroxychloroquine (JOQUER; n = 120 patients) and rituximab (TEARS; n = 120 patients) and from the 5-year follow-up of the ASSESS prospective cohort (n = 395 patients). Data were analysed at each visit for each patient, according to the day, the month of the year and the season. Linear mixed models were used to take into account the repeated structure of the data and to analyse a potential cyclic effect.

Results: A total of 744, 584, 848 and 682 pain, fatigue and dryness VASs were collected on 632 subjects in spring, summer, fall and winter, respectively. No significant difference was observed in pain, fatigue and dryness, according to the month of the year or the season (all p values > 0.05).

Conclusion: In pSS, seasonality does not affect patient-reported outcomes (PROs) on fatigue, pain and dryness.

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Arthritis Res Ther. 2020;22(39) © 2020 BioMed Central, Ltd.
Copyright to this article is held by the author(s), licensee BioMed Central Ltd. This is an Open Access article: verbatim copying and redistribution of this article are permitted in all media for any purpose, provided this notice is preserved along with the article's original citation.

Abstract and Introduction
Background
Methods
Results
Discussion
Conclusions
References

Table 1. Pain, fatigue and dryness by season for all spring, summer, fall and winter visits ( n = 2858 observations) in 632 patients
VAS	Spring	Summer	Fall	Winter	p value
n*	744	584	848	682
Pain^# mean (SD)	52.2 (27.9)	55.1 (28.1)	51.0 (28.7)	51.7 (28.4)	0.7541
Fatigue^# mean (SD)	61.9 (23.2)	62.2 (25.2)	60.0 (25.5)	61.9 (24.2)	0.7973
Dryness^# mean (SD)	58.9 (21.8)	61.2 (22.9)	56.9 (22.8)	57.9 (23.8)	0.4108
ESSPRI mean (SD)	57.7 (24.3)	59.5 (24.5)	55.9 (25.7)	57.2 (25.5)	0.7288

*Number of VAS; ^#in mm; ESSPRI EULAR Sjögren's Syndrome Patient Reported Index

Table S1. Drug regimens used at enrolment in the ASSESS cohort and number of patients with systemic immuno-modulatory drugs and symptomatic treatments of dryness.
Treatment modality	n (%)
Symptomatic treatments of dryness
Topical eye drops	268 (67.8)
Pilocarpine hydrochloride	100 (25.3)
Systemic immunomodulatory treatments
Corticosteroids	95 (24.1)
Hydroxychloroquine	121 (30.6)
Methotrexate	20 (5.1)
Leflunomide	2 (0.5)
Azathioprine	6 (1.5)
Mycophenolate mofetil	5 (1.3)
Cyclophosphamide	3 (0.8)
Rituximab	4 (1)
≥1 IS*	37 (9.4)

*IS=Immunosuppressive drugs;

Table S2. Influence of seasons onobjective assessments of ocular and oral dryness (Schirmer test ≤ 5 mm;Salivary flow ≤ 0.1mL/min).
Season	Eye drynessORa*[95%CI]	P value	Oral drynessORa* [95% CI]	P value
Fall^#	1	-	1	-
Summer	0.95 [0.43–2.14]	0.89	0.71 [0.24–1.43]	0.38
Winter	0.75 [0.38–1.53]	0.35	0,83 [0.34–1.68]	0.6
Spring	0.93 [0.42–1.8]	0.82	1,23 [0,5–2.64]	0.58

*Odds ratios were adjusted on age, immunosuppressive treatment regimens and symptomatic treatments of dryness. ^# Oral and ocular dryness values collected in fall were defined as reference for these analyses.

Table S3. Variations of pain, fatigue and dryness VASs (on a 100-unit scale) and of the ESSPRI score according to seasons, adjusted on age, immunosuppressive treatments and symptomatic treatments of dryness.
Differencesbetweenseasons*	Spring	P value	Summer	P value	Fall^#	Winter	P value
Pain [95%CI]	1.3 [-1.6; 4.4]	0.4	0 [-3; 2.9]	0.99	_	-0.3 [-3; 2.4]	0.83
Fatigue [95% CI]	1.3 [-1.3; 4]	0.33	0.4 [-2.2; 3]	0.79	_	-0.2 [-2.7; 2.2]	0.84
Dryness [95%CI]	1.3 [-1; 3.6]	0.27	2 [-0.3; 4.3]	0.09	_	0.6 [-1.5; 2.8]	0.55
ESSPRI [95%CI]	1.2 [-0.8; 3.2]	0.25	0.6 [-1.4; 2.6]	0.55	_	-0.2 [-2.1; 1.6]	0.82

*Improvements (in mm) of VASs and of the ESSPRI score between seasons, adjusted on age, immuno-suppressive treatment regimens and symptomatic treatments of dryness. ^# Values collected in fall were defined as reference for these analyses.

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