OBJECTIVE: To evaluate changes in salivary gland echostructure and vascularization after rituximab treatment in patients with primary Sjögren's syndrome (SS). METHODS:Twenty-eight patients with primary SS included in the multicenter, randomized, double-blind, placebo-controlled Tolerance and Efficacy of Rituximab in Primary Sjögren's Syndrome (TEARS) trial underwent salivary gland ultrasonography before the first placebo or rituximab infusion and then 6 months later. Trial inclusion criteria were scores of ≥50 mm on at least 2 of 4 visual analog scales (VAS) evaluating dryness, pain, fatigue, and global disease; and recent-onset (<10 years) biologically active primary SS and/or systemic primary SS. Patients were randomly assigned (1:1) to rituximab (1 gm at weeks 0 and 2) or placebo. Ultrasonography of both parotid and submandibular glands was performed to assess echostructure (using a semiquantitative score of 0-4, with improvement defined as a ≥1-point decrease), size of each gland, and vascularization based on the resistive index of the transverse facial artery of the parotid gland before and after lemon juice stimulation. RESULTS: Of the 28 patients, 5 (18%; 3 in the placebo group and 2 in the rituximab group) had clinically detectable bilateral parotid gland enlargement at baseline. Parotid parenchyma echostructure improved in 50% of the rituximab-treated patients versus 7% of the placebo-treated patients (P = 0.03). In the submandibular glands, echostructure also improved in a larger proportion of rituximab-treated patients, although the difference was not significant (36% versus 7% of placebo-treated patients; P = 0.16). Gland sizes and resistive index remained unchanged. CONCLUSION:Ultrasonography showed improved salivary gland echostructure in patients with primary SS receivingrituximab, with no changes in salivary gland size or vascularization, 6 months after the first infusion.
RCT Entities:
OBJECTIVE: To evaluate changes in salivary gland echostructure and vascularization after rituximab treatment in patients with primary Sjögren's syndrome (SS). METHODS: Twenty-eight patients with primary SS included in the multicenter, randomized, double-blind, placebo-controlled Tolerance and Efficacy of Rituximab in Primary Sjögren's Syndrome (TEARS) trial underwent salivary gland ultrasonography before the first placebo or rituximab infusion and then 6 months later. Trial inclusion criteria were scores of ≥50 mm on at least 2 of 4 visual analog scales (VAS) evaluating dryness, pain, fatigue, and global disease; and recent-onset (<10 years) biologically active primary SS and/or systemic primary SS. Patients were randomly assigned (1:1) to rituximab (1 gm at weeks 0 and 2) or placebo. Ultrasonography of both parotid and submandibular glands was performed to assess echostructure (using a semiquantitative score of 0-4, with improvement defined as a ≥1-point decrease), size of each gland, and vascularization based on the resistive index of the transverse facial artery of the parotid gland before and after lemon juice stimulation. RESULTS: Of the 28 patients, 5 (18%; 3 in the placebo group and 2 in the rituximab group) had clinically detectable bilateral parotid gland enlargement at baseline. Parotid parenchyma echostructure improved in 50% of the rituximab-treated patients versus 7% of the placebo-treated patients (P = 0.03). In the submandibular glands, echostructure also improved in a larger proportion of rituximab-treated patients, although the difference was not significant (36% versus 7% of placebo-treated patients; P = 0.16). Gland sizes and resistive index remained unchanged. CONCLUSION: Ultrasonography showed improved salivary gland echostructure in patients with primary SS receiving rituximab, with no changes in salivary gland size or vascularization, 6 months after the first infusion.
Authors: Luiz A Gueiros; Katherine France; Rachael Posey; Jacqueline W Mays; Barbara Carey; Thomas P Sollecito; Jane Setterfield; Sook Bin Woo; Donna Culton; Aimee S Payne; Giovanni Lodi; Martin S Greenberg; Scott De Rossi Journal: Oral Dis Date: 2019-06 Impact factor: 3.511
Authors: Sandrine Jousse-Joulin; Emmanuel Nowak; Divi Cornec; Jackie Brown; Andrew Carr; Marina Carotti; Benjamin Fisher; Joel Fradin; Alojzija Hocevar; Malin V Jonsson; Nicoletta Luciano; Vera Milic; John Rout; Elke Theander; Aaltje Stel; Hendrika Bootsma; Arjan Vissink; Chiara Baldini; Alan Baer; Wan Fai Ng; Simon Bowman; Zarrin Alavi; Alain Saraux; Valérie Devauchelle-Pensec Journal: RMD Open Date: 2017-06-09
Authors: Benjamin A Fisher; Colin C Everett; John Rout; John L O'Dwyer; Paul Emery; Costantino Pitzalis; Wan-Fai Ng; Andrew Carr; Colin T Pease; Elizabeth J Price; Nurhan Sutcliffe; Jimmy Makdissi; Anwar R Tappuni; Nagui S T Gendi; Frances C Hall; Sharon P Ruddock; Catherine Fernandez; Claire T Hulme; Kevin A Davies; Christopher John Edwards; Peter C Lanyon; Robert J Moots; Euthalia Roussou; Andrea Richards; Linda D Sharples; Michele Bombardieri; Simon J Bowman Journal: Ann Rheum Dis Date: 2017-12-23 Impact factor: 19.103
Authors: Valérie Devauchelle-Pensec; Jacques-Eric Gottenberg; Sandrine Jousse-Joulin; Jean-Marie Berthelot; Aleth Perdriger; Eric Hachulla; Pierre Yves Hatron; Xavier Puechal; Véronique Le Guern; Jean Sibilia; Laurent Chiche; Vincent Goeb; Olivier Vittecoq; Claire Larroche; Anne Laure Fauchais; Gilles Hayem; Jacques Morel; Charles Zarnitsky; Jean Jacques Dubost; Philippe Dieudé; Jacques Olivier Pers; Divi Cornec; Raphaele Seror; Xavier Mariette; Emmanuel Nowak; Alain Saraux Journal: PLoS One Date: 2015-09-14 Impact factor: 3.240