Evolution of Disease Activity over a 5-Year Period in the 395 Patients with Primary SjöGren’s Syndrome of the Assess Prospective Cohort

Jacques-Eric Gottenberg¹, Raphaele Seror², Alain Saraux³, Valerie Devauchelle⁴, Emmanuelle Dernis Labous⁵, Philippe Dieudé⁶, Jean-Jacques Dubost⁷, Anne Laure Fauchais⁸, Vincent Goeb⁹, Claire Larroche¹⁰, Véronique Le-Guern¹¹, Eric Hachulla¹², Pierre Yves Hatron¹³, Jacques Morel¹⁴, Aleth Perdriger¹⁵, Stephanie Rist Bouillon¹⁶, Damien Sène¹⁷, Olivier Vittecoq¹⁸, Jean Sibilia¹⁹, Philippe Ravaud²⁰ and Xavier Mariette²¹, ¹Department of Rheumatology, Strasbourg University Hospital, Strasbourg, France, ²Department of Rheumatology, Assistance Publique–Hopitaux de Paris, Hôpitaux Universitaires Paris-Sud, Le Kremlin Bicêtre, France, ³Rheumatology, Brest University Hospital, Brest, France, ⁴Service de Rhumatologie, Department of Rheumatology, Brest University Hospital, Brest, France, Brest, France, ⁵Le Mans Hospital, Le Mans, France, ⁶Rheumatology, Hôpital Bichat, Paris, France, ⁷Rheumatology department CHU Clermont-Ferrand, Clermont-Ferrand, France, ⁸Rheumatology, Limoges, France, ⁹Rhumatologie, CHU Amiens, Amiens, France, ¹⁰Internal Medicine, Paris, France, ¹¹service de médecine interne, Department of Internal Medicine, Referral Center for Rare Autoimmune and Systemic Diseases, Hôpital Cochin, AP–HP, Université Paris Descartes, Paris, France, ¹²Internal Medicine, Lille University Hospital, Lille, France, ¹³Internal Medicine, Lille, France, ¹⁴Rheumatology, Department of Rheumatology, Montpellier University Hospital, Montpellier, France, ¹⁵C.H.R. Hôpital Sud, Rennes, France, ¹⁶Rhumatologie, Hopital La Source, La Source, France, ¹⁷Department of Internal Medicine, Pitié-Salpêtrière Hospital, Paris, France, ¹⁸Rheumatology, Rouen University Hospital &INSERM U905, Rouen, France, ¹⁹Department of Rheumatology, Strasbourg University Hospital, Strasbourg, France, ²⁰Epidemiologist, PARIS, France, ²¹Rheumatology, Rheumatology department, Bicetre Hospital, Paris-Sud University, Le Kremlin Bicetre, France

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: biomarkers and registry, Sjogren's syndrome

Session Information

Date: Tuesday, November 15, 2016

Title: Sjögren's Syndrome - Poster II: Clinical Science

Session Type: ACR Poster Session C

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

Background/Purpose: Little is known about the natural history of primary Sjögren’s syndrome due to the limited number of prospective cohorts followed up in a yearly manner. International validated disease activity scores were recently established and are now used as inclusion criteria and as primary outcome measures in many randomized controlled trials. This is therefore of critical importance to know the evolution of these scores and the proportion of patients experiencing a change in these scores.

Methods: The ASsessment of Systemic complications and Evolution in primary Sjögren’s Syndrome (ASSESS) cohort is a prospective ongoing cohort of 395 patients. All patients have a medical examination every year by a trained physician, who collects the ESSDAI (Eular Sjögren’s Syndrome Disease Activity Index), which scores systemic disease activity, clinical ESSDAI (clin ESSDAI, which scores systemic disease activity without the biological domain of the ESSDAI)and the ESSPRI (Eular Sjögren’s Syndrome Patient Index), a patient-related outcome which scores dryness, pain and fatigue.

Results: Baseline data At enrollment in the 395 patients of the cohort, median ESSDAI, clin ESSDAI and ESSPRI were 3 [2-8], 3 [0-8] and 5.7 [4-7], respectively. 28.2% and 10.6% of patients had moderate systemic disease activity (5≤ ESSDAI < 13) or high systemic disease activity (ESSDAI ≥ 14), respectively. 62.2% of patients had an ESSPRI≥ 5. Follow-up data During the 5 years of annual follow up, 23.3 and 23.4% of patients with a baseline ESSDAI or a clinESSDAI < 5, respectively, had at least at one follow up visit, an ESSDAI or clinESSDAI ≥ 5. 10.5% and 12.9% of patients with a baseline ESSDAI<14 or clinESSDAI<14, respectively, had at least at one follow up visit an ESSDAI or clin ESSDAI≥14. Regarding changes in domains of the ESSDAI over the 5 years of follow up, the most frequent changes were observed in the biological (46.2% of patients), articular (34.9%), hematological (28.9%), pulmonary (25.1%), and glandular domain (20.5%). 25% of patients with a baseline ESSPRI<5 had at least at follow up one visit an ESSPRI ≥5. 39.8% of patients with baseline ESSDAI and ESSPRI<5 had at least at one follow up visit an ESSDAI or an ESSPRI ≥5.

Conclusion: Systemic manifestations and symptoms evolve over time during the 5-year follow-up in patients with primary Sjögren’s Syndrome. Approximately one fourth of the patients with no systemic activity or an acceptable symptoms status at baseline evolved to a status of moderate disease activity or to disabling symptoms, respectively. 40% of patients without any active disease or disabling symptoms at baseline developed systemic complications or disabling symptoms within 5 years.

Disclosure: J. E. Gottenberg, Abbvie, BMS, Gsk, Jannssen, Lilly, MSD, Pfizer, Roche, UCB, 5; R. Seror, None; A. Saraux, None; V. Devauchelle, None; E. Dernis Labous, None; P. Dieudé, None; J. J. Dubost, None; A. L. Fauchais, None; V. Goeb, None; C. Larroche, None; V. Le-Guern, None; E. Hachulla, None; P. Y. Hatron, None; J. Morel, None; A. Perdriger, None; S. Rist Bouillon, None; D. Sène, None; O. Vittecoq, None; J. Sibilia, None; P. Ravaud, None; X. Mariette, None.

To cite this abstract in AMA style:

Gottenberg JE, Seror R, Saraux A, Devauchelle V, Dernis Labous E, Dieudé P, Dubost JJ, Fauchais AL, Goeb V, Larroche C, Le-Guern V, Hachulla E, Hatron PY, Morel J, Perdriger A, Rist Bouillon S, Sène D, Vittecoq O, Sibilia J, Ravaud P, Mariette X. Evolution of Disease Activity over a 5-Year Period in the 395 Patients with Primary SjöGren’s Syndrome of the Assess Prospective Cohort [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/evolution-of-disease-activity-over-a-5-year-period-in-the-395-patients-with-primary-sjogrens-syndrome-of-the-assess-prospective-cohort/. Accessed .

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