Is There a Seasonal Effect on Fatigue, Pain, and Dryness in Primary Sjögren's Syndrome? Data from the Prospective Assess Cohort and from 3 Randomized Controlled Trials

Pierre-Marie DURET¹, Nicolas MEYER², Alain Saraux³, Valérie Devauchelle-Pensec⁴, Jean Sibilia⁵, Raphaele Seror⁶, Véronique Le-Guern⁷, Claire Larroche⁸, Aleth Perdriger⁹, Xavier Mariette¹⁰ and Jacques-Eric Gottenberg¹¹, ¹Rhumatology, Hautepierre Hospital, STRASBOURG, France, ²clinical research, Hautepierre Hospital, STRASBOURG, France, ³Rheumatology, Brest University Hospital, Brest, France, ⁴Department of Rheumatology, Brest University Hospital, Brest, France, ⁵Department of Rheumatology, Strasbourg University Hospital, Strasbourg, France, ⁶Center for Immunology of Viral Infections and Autoimmune Diseases, Assistance Publique – Hôpitaux de Paris, Hôpitaux Universitaires Paris-Sud, Le Kremlin-Bicêtre, Université Paris Sud, INSERM, Paris, France, Paris, France, ⁷service de médecine interne, Department of Internal Medicine, Referral Center for Rare Autoimmune and Systemic Diseases, Hôpital Cochin, AP–HP, Université Paris Descartes, Paris, France, ⁸Internal Medicine, Paris, France, ⁹Service de Rhumatologie, CHRU de Rennes, Rennes, France, ¹⁰Université Paris-Sud, AP-HP, Hôpitaux Universitaires Paris-Sud, Paris, France, ¹¹CNRS, Immunopathologie et Chimie Thérapeutique/Laboratory of Excellence Medalis, Institut de Biologie Moléculaire et Cellulaire, Strasbourg, France

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: fatigue and pain, Sjogren's syndrome

Session Information

Date: Monday, November 6, 2017

Title: Sjögren's Syndrome Poster II: Clinical Research

Session Type: ACR Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose:

A seasonal effect was reported on fatigue and pain in rheumatoid arthritis. We speculated that fall and winter could be associated with increased fatigue and pain and that spring and summer could be associated with increased dryness. If a seasonal effect plays a role on patients’s symptoms, it has to be taken into account in clinical trials and also in daily practice.

Our objective was to assess a seasonal effect on fatigue, pain and dryness.

Methods:

The data (date, VAS pain, fatigue, dryness) were extracted from three negative placebo-controlled randomized controlled trials (infliximab (n= 103 patients), hydroxychloroquine (JOQUER, n= 120 patients) and rituximab (TEARS n=120)) and from the ASSESS prospective cohort (n= 395 patients). VAS pain, fatigue and dryness were analyzed at each visit for each patient, according to the day of the year, the month of the year, and the season. Linear mixed models were fitted with a fixed time effect (month, with or without cosinus transformation, or season effect, in distinct models) with a random subject effect used to take into account the repeated structure of the data and analyze a potential cyclic effect. Statistical analyses were performed using R3.3.1 with the LME4 and HGLM libraries.

Results:

744, 584, 848 and 682 pain, fatigue and dryness VAS were collected on 632 subjects in spring, summer, fall and winter, respectively. Mean (SD) pain VAS was 52.2 (27.9), 55.1 (28.1), 51.0 (28.7) and 51.7 (28.4) in spring, summer, fall and winter, respectively. Mean (SD) fatigue was 61.9 (23.2), 62.2 (25.2), 60.0 (25.5), 61.9 (24.2), respectively. Mean (SD) dryness was 58.9 (21.8), 61.2 (22.9), 56.9 (22.8), and 57.9 (23.8), respectively (Figure 1). No significant difference was observed in pain, fatigue and dryness, according to the day of the year, the month or the season (all p-values >0.05). Variations from month to month or season to season of mean pain, fatigue and dryness were mild (maximum between-months variation for pain was 7.22 on a 100-unit scale). All observed fluctuations were well lower than MCIIs for fatigue, dryness and pain (20, 10 and 10 point on a 100-point scale, respectively, ref 1).

Conclusion:

Intensity of perceived dryness, pain and fatigue do not seem to have meaningful fluctuations according to seasons or months. Therefore, the impact on the main symptoms of the disease in randomized trial is not biased by a seasonal effect.

Ref 1 : Gottenberg JE, et al. JAMA 2014

Disclosure: P. M. DURET, None; N. MEYER, None; A. Saraux, None; V. Devauchelle-Pensec, Roche-Chugai provided me tocilizumab for the SEMAPHORER study, 2; J. Sibilia, None; R. Seror, None; V. Le-Guern, None; C. Larroche, None; A. Perdriger, None; X. Mariette, None; J. E. Gottenberg, BMS, Gilead, Medimune,Pfzer SanofiAventis, Roche, Ucb, 2.

To cite this abstract in AMA style:

DURET PM, MEYER N, Saraux A, Devauchelle-Pensec V, Sibilia J, Seror R, Le-Guern V, Larroche C, Perdriger A, Mariette X, Gottenberg JE. Is There a Seasonal Effect on Fatigue, Pain, and Dryness in Primary Sjögren’s Syndrome? Data from the Prospective Assess Cohort and from 3 Randomized Controlled Trials [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/is-there-a-seasonal-effect-on-fatigue-pain-and-dryness-in-primary-sjogrens-syndrome-data-from-the-prospective-assess-cohort-and-from-3-randomized-controlled-trials/. Accessed .

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