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1. Symptom-based stratification of patients with primary Sjögren's syndrome: multi-dimensional characterisation of international observational cohorts and reanalyses of randomised clinical trials

Author

Devauchelle-Pensec, Valerie, Dieude, Philippe, Dubost, Jean Jacques, Fauchais, Anne-Laure, Goeb, Vincent, Hachulla, Eric, Larroche, Claire, Le Guern, Véronique, Morel, Jacques, Perdriger, Aleth, Puéchal, Xavier, Rist, Stephanie, Sen, Damien, Sibilia, Jean, Vittecoq, Olivier, Benessiano, Joelle, Tubiana, Sarah, Inamo, Karine, Gaete, Stanie, Batouche, Djilali, Molinari, Domitille, Randrianandrasana, Mickael, Pane, Isabelle, Abbe, Adeline, Baron, Gabriel, Ravaud, Philippe, Gottenberg, Jacques-Eric, Saraux, Alain, Devauchelle-Pensec, Valérie, Hayem, Gilles, Hatron, Pierre, Sene, Damien, Zarnitsky, Charles, Furlan, Valérie, Perrodeau, Elodie, Seror, Raphaele, Mariette, Xavier, Brown, S, Navarro, N Coy, Pitzalis, C, Emery, P, Pavitt, S, Gray, J, Hulme, C, Hall, F, Busch, R, Smith, P, Dawson, L, Bombardieri, M, Ng, W-F, Pease, C, Price, E, Sutcliffe, N, Woods, C, Ruddock, S, Everett, C, Reynolds, C, Skinner, E, Poveda-Gallego, A, Rout, J, Macleod, I, Rauz, S, Bowman, S, Ng, Wan-Fai, Bowman, Simon J, Griffiths, Bridget, Hall, Frances, Bacaba, Elalaine C, Frankland, Helen, Moots, Robert, Chadravarty, Kuntal, Lamabadusuriya, Shamin, Bombardieri, Michele, Pitzalis, Constantino, Sutcliffe, Nurhan, Breston, Celia, Gendi, Nagui, Culfear, Karen, Riddell, Claire, Hamburger, John, Richards, Andrea, Rauz, Saaeh, Brailsford, Sue, Dasgin, Joanne, Logan, Joanne, Mulherin, Diarmuid, Andrews, Jacqueline, Emery, Pau, McManus, Alison, Pease, Colin, Pickles, David, Booth, Alison, Regan, Marian, Kin, Jon King, Holt, Amanda, Dimitroulas, Theodoros, Kadiki, Lucy, Kaur, Daljit, Kitas, George, Khan, Abdul, Cosier, Tracey, Panthakalam, Mintrim, Kell, Lloyd, Mark, Moore, Lisa, Gordon, Esther, Lawson, Cathy, Gupta, Monica, Hunter, John, Stirton, Lesley, Ortiz, Gill, Price, Elizabeth, Pelger, Suzannah, Gorman, Claire, Hans, Balinder, Clunie, Gavin, Lane, Suzanne, Rose, Ginny, Cuckow, Sue, Batley, Michael, Einosas, Ruby, Knight, Susan, Symmons, Deborah, Jones, Beverley, Carr, Andrew, Edgar, Suzanne, Figuereido, Francisco, Foggo, Heather, Lendrem, Dennis, Macleod, Iain, Mitchell, Sheryl, Downie, Christine, Tarn, Jessica, Locke, James, Al-Ali, Shereen, Legg, Sarah, Mirza, Kamran, Hargreaves, Ben, Hetherington, Laura, Jones, Adrian, Lanyon, Peter, Muir, Alice, White, Paula, Young-Min, Steven, Pugmire, Susan, Vadivelu, Saravanan, Cooper, Annie, Watkins, Marianne, Field, Anne, Kaye, Stephen, Mewar, Devesh, Medcalf, Patricia, Tomlinson, Pamela, Whiteside, Debbie, McHugh, Neil, Pauling, John, James, Julie, Dowden, Andrea, Akil, Mohammed, McDermott, Jayne, Godia, Olivia, Coady, David, Kidd, Elizabeth, Palmer, Lynne, Li, Charles, Bartrum, Sarah, Mead, De, Dasgupta, Bhaskar, Katsande, Victoria, Long, Pamela, Vermaak, Erin, Turner, Janet, Chandra, Usha, MacKay, Kirsten, Fedele, Stefano, Ferenkeh-Koroma, Ada, Giles, Ian, Isenberg, David, MaConnell, Helena, Ahwiren, Nyarko, Porter, Stephen, Allcoa, Paul, McLaren, John, Tarn, Jessica R, Howard-Tripp, Nadia, Lendrem, Dennis W, Skelton, Andrew J, James, Katherine, McMeekin, Peter, Hackett, Katie L, Lendrem, B Clare, Casement, John, Pease, Colin T, Emery, Paul, Pitzalis, Costantino, Saravanan, Vadivelu, Johnsen, Svein J A, Norheim, Katrine B, Omdal, Roald, Stocken, Deborah, Everett, Colin, Fernandez, Catherine, and Isaacs, John D

Published
2019
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2. Physical activity but not sedentary activity is reduced in primary Sjögren’s syndrome

Author

Ng, Wan-Fai, Miller, Ariana, Bowman, Simon J., Price, Elizabeth J., Kitas, George D., Pease, Colin, Emery, Paul, Lanyon, Peter, Hunter, John, Gupta, Monica, Giles, Ian, Isenberg, David, McLaren, John, Regan, Marian, Cooper, Annie, Young-Min, Steven A., McHugh, Neil, Vadivelu, Saravanan, Moots, Robert J., Coady, David, MacKay, Kirsten, Dasgupta, Bhaskar, Sutcliffe, Nurhan, Bombardieri, Michele, Pitzalis, Costantino, Griffiths, Bridget, Mitchell, Sheryl, Miyamoto, Samira Tatiyama, Trenell, Michael, Hall, Frances, Bacabac, Elalaine C., Moots, Robert, Chakravarty, Kuntal, Lamabadusuriya, Shamin, Bombardieri, Michele, Pitzalis, Constantino, Sutcliffe, Nurhan, Gendi, Nagui, Adeniba, Rashidat, Hamburger, John, Richards, Andrea, Rauz, Saaeha, Brailsford, Sue, Logan, Joanne, Mulherin, Diarmuid, Andrews, Jacqueline, Emery, Paul, McManus, Alison, Pease, Colin, Booth, Alison, Regan, Marian, Dimitroulas, Theodoros, Kadiki, Lucy, Kaur, Daljit, Kitas, George, Lloyd, Mark, Moore, Lisa, Gordon, Esther, Lawson, Cathy, Gupta, Monica, Hunter, John, Stirton, Lesley, Ortiz, Gill, Price, Elizabeth, Clunie, Gavin, Rose, Ginny, Cuckow, Sue, Knight, Susan, Symmons, Deborah, Jones, Beverley, Al-Ali, Shereen, Carr, Andrew, Collins, Katherine, Corbett, Ian, Downie, Christine, Edgar, Suzanne, Carrozzo, Marco, Figuereido, Francisco, Foggo, Heather, James, Katherine, Lendrem, Dennis, Macleod, Iain, Mawson, Philip, Mitchell, Sheryl, Natasari, Andini, Stocks, Philip, Tarn, Jessica, Jones, Adrian, Lanyon, Peter, Muir, Alice, White, Paula, Young-Min, Steven, Pugmire, Susan, Vadivelu, Saravanan, Cooper, Annie, Watkins, Marianne, Field, Anne, Kaye, Stephen, Mewar, Devesh, Medcalf, Patricia, Tomlinson, Pamela, Whiteside, Debbie, McHugh, Neil, Pauling, John, James, Julie, Olaitan, Nike, Akil, Mohammed, McDermott, Jayne, Godia, Olivia, Coady, David, Kidd, Elizabeth, Palmer, Lynne, Dasgupta, Bhaskar, Katsande, Victoria, Long, Pamela, Li, Charles, Chandra, Usha, MacKay, Kirsten, Fedele, Stefano, Ferenkeh-Koroma, Ada, Giles, Ian, Isenberg, David, Maconnell, Helena, Porter, Stephen, Allcoat, Paul, McLaren, John, and on behalf of the UK Primary Sjögren’s Syndrome Registry

Published
2017
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3. Symptom-based stratification of patients with primary Sjögren's syndrome: multi-dimensional characterisation of international observational cohorts and reanalyses of randomised clinical trials

Author

Tarn, Jessica R, Howard-Tripp, Nadia, Lendrem, Dennis W, Mariette, Xavier, Saraux, Alain, Devauchelle-Pensec, Valerie, Seror, Raphaele, Skelton, Andrew J, James, Katherine, McMeekin, Peter, Al-Ali, Shereen, Hackett, Kate, Lendrem, B Clare, Hargreaves, Ben, Casement, John, Mitchell, Sheryl, Bowman, Simon J, Price, Elizabeth, Pease, Colin T, Emery, Paul, Lanyon, Peter, Hunter, John, Gupta, Monica, Bombardieri, Michele, Sutcliffe, Nurhan, Pitzalis, Costantino, McLaren, John, Cooper, Annie, Regan, Marian, Giles, Ian, Isenberg, David, Saravanan, Vadivelu, Coady, David, Dasgupta, Bhaskar, McHugh, Neil, Young-Min, Steven, Moots, Robert, Gendi, Nagui, Akil, Mohammed, Griffiths, Bridget, Johnsen, Svein J A, Norheim, Katrine B, Omdal, Roald, Stocken, Deborah, Everett, Colin, Fernandez, Catherine, Isaacs, John D, Gottenberg, Jacques-Eric, Ng, Wan-Fai, Dieude, Philippe, Dubost, Jean Jacques, Fauchais, Anne-Laure, Goeb, Vincent, Hachulla, Eric, Larroche, Claire, Le Guern, Véronique, Morel, Jacques, Perdriger, Aleth, Puéchal, Xavier, Rist, Stephanie, Sen, Damien, Sibilia, Jean, Vittecoq, Olivier, Benessiano, Joelle, Tubiana, Sarah, Inamo, Karine, Gaete, Stanie, Batouche, Djilali, Molinari, Domitille, Randrianandrasana, Mickael, Pane, Isabelle, Abbe, Adeline, Baron, Gabriel, Ravaud, Philippe, Dubost, Jean-Jacques, Rist, Stéphanie, Devauchelle-Pensec, Valérie, Hayem, Gilles, Hatron, Pierre, Sene, Damien, Zarnitsky, Charles, Furlan, Valérie, Perrodeau, Elodie, Brown, S, Navarro, N Coy, Pitzalis, C, Emery, P, Pavitt, S, Gray, J, Hulme, C, Hall, F, Busch, R, Smith, P, Dawson, L, Bombardieri, M, Ng, W-F, Pease, C, Price, E, Sutcliffe, N, Woods, C, Ruddock, S, Everett, C, Reynolds, C, Skinner, E, Poveda-Gallego, A, Rout, J, Macleod, I, Rauz, S, Bowman, S, Hall, Frances, Bacaba, Elalaine C, Frankland, Helen, Chadravarty, Kuntal, Lamabadusuriya, Shamin, Pitzalis, Constantino, Breston, Celia, Culfear, Karen, Riddell, Claire, Hamburger, John, Richards, Andrea, Rauz, Saaeh, Brailsford, Sue, Dasgin, Joanne, Logan, Joanne, Mulherin, Diarmuid, Andrews, Jacqueline, Emery, Pau, McManus, Alison, Pease, Colin, Pickles, David, Booth, Alison, Kin, Jon King, Holt, Amanda, Dimitroulas, Theodoros, Kadiki, Lucy, Kaur, Daljit, Kitas, George, Khan, Abdul, Cosier, Tracey, Panthakalam, Mintrim, Kell, Lloyd, Mark, Moore, Lisa, Gordon, Esther, Lawson, Cathy, Stirton, Lesley, Ortiz, Gill, Pelger, Suzannah, Gorman, Claire, Hans, Balinder, Clunie, Gavin, Lane, Suzanne, Rose, Ginny, Cuckow, Sue, Batley, Michael, Einosas, Ruby, Knight, Susan, Symmons, Deborah, Jones, Beverley, Carr, Andrew, Edgar, Suzanne, Figuereido, Francisco, Foggo, Heather, Lendrem, Dennis, Macleod, Iain, Downie, Christine, Tarn, Jessica, Locke, James, Legg, Sarah, Mirza, Kamran, Hetherington, Laura, Jones, Adrian, Muir, Alice, White, Paula, Pugmire, Susan, Vadivelu, Saravanan, Watkins, Marianne, Field, Anne, Kaye, Stephen, Mewar, Devesh, Medcalf, Patricia, Tomlinson, Pamela, Whiteside, Debbie, Pauling, John, James, Julie, Dowden, Andrea, McDermott, Jayne, Godia, Olivia, Kidd, Elizabeth, Palmer, Lynne, Li, Charles, Bartrum, Sarah, Mead, De, Katsande, Victoria, Long, Pamela, Vermaak, Erin, Turner, Janet, Chandra, Usha, MacKay, Kirsten, Fedele, Stefano, Ferenkeh-Koroma, Ada, MaConnell, Helena, Ahwiren, Nyarko, Porter, Stephen, and Allcoa, Paul

Subjects
medicine.medical_specialty, business.industry, Immunology, Hydroxychloroquine, Placebo, Article, Rheumatology, B700, Clinical trial, B900, Internal medicine, Cohort, Immunology and Allergy, Medicine, Observational study, Rituximab, business, Depression (differential diagnoses), medicine.drug
Abstract

Summary Background Heterogeneity is a major obstacle to developing effective treatments for patients with primary Sjogren's syndrome. We aimed to develop a robust method for stratification, exploiting heterogeneity in patient-reported symptoms, and to relate these differences to pathobiology and therapeutic response. Methods We did hierarchical cluster analysis using five common symptoms associated with primary Sjogren's syndrome (pain, fatigue, dryness, anxiety, and depression), followed by multinomial logistic regression to identify subgroups in the UK Primary Sjogren's Syndrome Registry (UKPSSR). We assessed clinical and biological differences between these subgroups, including transcriptional differences in peripheral blood. Patients from two independent validation cohorts in Norway and France were used to confirm patient stratification. Data from two phase 3 clinical trials were similarly stratified to assess the differences between subgroups in treatment response to hydroxychloroquine and rituximab. Findings In the UKPSSR cohort (n=608), we identified four subgroups: Low symptom burden (LSB), high symptom burden (HSB), dryness dominant with fatigue (DDF), and pain dominant with fatigue (PDF). Significant differences in peripheral blood lymphocyte counts, anti-SSA and anti-SSB antibody positivity, as well as serum IgG, κ-free light chain, β2-microglobulin, and CXCL13 concentrations were observed between these subgroups, along with differentially expressed transcriptomic modules in peripheral blood. Similar findings were observed in the independent validation cohorts (n=396). Reanalysis of trial data stratifying patients into these subgroups suggested a treatment effect with hydroxychloroquine in the HSB subgroup and with rituximab in the DDF subgroup compared with placebo. Interpretation Stratification on the basis of patient-reported symptoms of patients with primary Sjogren's syndrome revealed distinct pathobiological endotypes with distinct responses to immunomodulatory treatments. Our data have important implications for clinical management, trial design, and therapeutic development. Similar stratification approaches might be useful for patients with other chronic immune-mediated diseases. Funding UK Medical Research Council, British Sjogren's Syndrome Association, French Ministry of Health, Arthritis Research UK, Foundation for Research in Rheumatology. Video Abstract Download : Download video (77MB) Symptom-based stratification of patients with Sjogren's syndrome

Published
2019

4. Mixed‐Methods Study Identifying Key Intervention Targets to Improve Participation in Daily Living Activities in Primary Sjögren's Syndrome Patients

Author

Hackett, Katie L., Deane, Katherine H. O., Newton, Julia L., Deary, Vincent, Bowman, Simon J., Rapley, Tim, Ng, Wan‐Fai, Brailsford, Sue, Dasgin, Joanne, Dimitroulas, Theodoros, Kadiki, Lucy, Kaur, Daljit, Kitas, George, Gordon, Esther, Lawson, Cathy, Ortiz, Gill, Price, Elizabeth, Pegler, Suzannah, Clunie, Gavin, Lane, Suzanne, Rose, Ginny, Cuckow, Sue, Griffiths, Bridget, Mitchell, Sheryl, Downie, Christine, Legg, Sarah, Pugmire, Susan, Vadivelu, Saravanan, Field, Anne, Kaye, Stephen, Mewar, Devesh, Medcalf, Patricia, Tomlinson, Pamela, Whiteside, Debbie, McHugh, Neil, Pauling, John, James, Julie, Dowden, Andrea, Coady, David, Kidd, Elizabeth, Palmer, Lynne, Dasgupta, Bhaskar, Katsande, Victoria, Long, Pamela, Godia, Olivia, Chandra, Usha, and MacKay, Kirsten

Abstract

Functional ability and participation in life situations are compromised in many primary Sjögren's syndrome (SS) patients. This study aimed to identify the key barriers and priorities to participation in daily living activities, in order to develop potential future interventions. Group concept mapping, a semiquantitative, mixed‐methods approach was used to identify and structure ideas from UKprimary SSpatients, adult household members living with a primary SSpatient, and health care professionals. Brainstorming generated ideas, which were summarized into a final set of statements. Participants individually arranged these statements into themes and rated each statement for importance. Multidimensional scaling and hierarchical cluster analysis were applied to sorted and rated data to produce visual representations of the ideas (concept maps), enabling identification of agreed priority areas for interventions. A total of 121 patients, 43 adult household members, and 67 health care professionals took part. In sum, 463 ideas were distilled down to 94 statements. These statements were grouped into 7 clusters: Patient Empowerment, Symptoms, Wellbeing, Access and Coordination of Health Care, Knowledge and Support, Public Awareness and Support, and Friends and Family. Patient Empowerment and Symptoms were rated as priority conceptual themes. Important statements within priority clusters indicate patients should be taken seriously and supported to self‐manage symptoms of oral and ocular dryness, fatigue, pain, and poor sleep. Our data highlighted the fact that in addition to managing primary SSsymptoms, interventions aiming to improve patient empowerment, general wellbeing, access to health care, patient education, and social support are important to facilitate improved participation in daily living activities.

Published
2018
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5. Subjective and Objective Measures of Dryness Symptoms in Primary Sjögren's Syndrome: Capturing the Discrepancy

Author

Bezzina, Oriana M., Gallagher, Peter, Mitchell, Sheryl, Bowman, Simon J., Griffiths, Bridget, Hindmarsh, Victoria, Hargreaves, Ben, Price, Elizabeth J., Pease, Colin T., Emery, Paul, Lanyon, Peter, Bombardieri, Michele, Sutcliffe, Nurhan, Pitzalis, Costantino, Hunter, John, Gupta, Monica, McLaren, John, Cooper, Anne M., Regan, Marian, Giles, Ian P., Isenberg, David A., Saravanan, Vadivelu, Coady, David, Dasgupta, Bhaskar, McHugh, Neil J., Young‐Min, Steven A., Moots, Robert J., Gendi, Nagui, Akil, Mohammed, MacKay, Kirsten, Ng, W. Fai, Robinson, Lucy J., Bacabac, Elalaine C, Moots, Robert, Chakravarty, Kuntal, Lamabadusuriya, Shamin, Pitzalis, Constantino, Adeniba, Rashidat, Hamburger, John, Richards, Andrea, Rauz, Saaeha, Brailsford, Sue, Logan, Joanne, Mulherin, Diarmuid, Andrews, Jacqueline, McManus, Alison, Pease, Colin, Booth, Alison, Dimitroulas, Theodoros, Kadiki, Lucy, Kaur, Daljit, Kitas, George, Lloyd, Mark, Moore, Lisa, Gordon, Esther, Lawson, Cathy, Stirton, Lesley, Ortiz, Gill, Price, Elizabeth, Clunie, Gavin, Rose, Ginny, Cuckow, Sue, Knight, Susan, Symmons, Deborah, Jones, Beverley, Al‐Ali, Shereen, Carr, Andrew, Collins, Katherine, Corbett, Ian, Downie, Christine, Edgar, Suzanne, Carrozzo, Marco, Figuereido, Francisco, Foggo, Heather, Humphreys, Claire, James, Katherine, Lendrem, Dennis, Locke, James, Macleod, Iain, Mawson, Philip, Stocks, Philip, Tarn, Jessica, Jones, Adrian, Muir, Alice, White, Paula, Young‐Min, Steven, Pugmire, Susan, Vadivelu, Saravanan, Cooper, Annie, Watkins, Marianne, Field, Anne, Kaye, Stephen, Mewar, Devesh, Medcalf, Patricia, Tomlinson, Pamela, Whiteside, Debbie, McHugh, Neil, Pauling, John, James, Julie, Olaitan, Nike, McDermott, Jayne, Godia, Olivia, Kidd, Elizabeth, Palmer, Lynne, Katsande, Victoria, Long, Pamela, Li, Charles, Chandra, Usha, Fedele, Stefano, Ferenkeh‐Koroma, Ada, Giles, Ian, Isenberg, David, Maconnell, Helena, Porter, Stephen, and Allcoat, Paul

Abstract

To develop a novel method for capturing the discrepancy between objective tests and subjective dryness symptoms (a sensitivity scale) and to explore predictors of dryness sensitivity. Archive data from the UKPrimary Sjögren's Syndrome Registry (n = 688) were used. Patients were classified on a scale from −5 (stoical) to +5 (sensitive) depending on the degree of discrepancy between their objective and subjective symptoms classes. Sensitivity scores were correlated with demographic variables, disease‐related factors, and symptoms of pain, fatigue, anxiety, and depression. Patients were on average relatively stoical for both types of dryness symptoms (mean ± SDocular dryness −0.42 ± 2.2 and −1.24 ± 1.6 oral dryness). Twenty‐seven percent of patients were classified as sensitive to ocular dryness and 9% to oral dryness. Hierarchical regression analyses identified the strongest predictor of ocular dryness sensitivity to be self‐reported pain and that of oral dryness sensitivity to be self‐reported fatigue. Ocular and oral dryness sensitivity can be classified on a continuous scale. The 2 symptom types are predicted by different variables. A large number of factors remain to be explored that may impact symptom sensitivity in primary Sjögrenʼs syndrome, and the proposed method could be used to identify relatively sensitive and stoical patients for future studies.

Published
2017
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