Randomized Controlled Trial of Rituximab and Cost‐Effectiveness Analysis in Treating Fatigue and Oral Dryness in Primary Sjögren's Syndrome

Bowman, Simon; Everett, Colin; O’Dwyer, John; Emery, Paul; Pitzalis, Costantino; Ng, Wan‐Fai; Pease, Colin; Price, Elizabeth; Sutcliffe, Nurhan; Gendi, Nagui; Hall, Frances; Ruddock, Sharon; Fernandez, Catherine; Reynolds, Catherine; Hulme, Claire; Davies, John; Edwards, Christopher J; Lanyon, Peter; Moots, Robert J.; Roussou, Euthalia; Giles, Ian; Sharples, Linda D.; Bombardieri, Michèle

doi:10.1002/art.40093

Cited by 200 publications

(144 citation statements)

References 26 publications

Supporting

Mentioning

131

Contrasting

Unclassified

Order By: Relevance

“…Positive results on total dryness scores or subscores for oral and ocular dryness were seen in most studies (Table 3). Although no decrease in dryness VAS was seen in de TRACTISS study, improvement was seen in the TEARS study [8,9]. VAS dryness scores improved significantly among patients in the rituximab group, although b 30 mm, which was set as minimum to achieve the primary end-point.…”

Section: Effects On Exocrine Gland Function and Sicca Symptomsmentioning

confidence: 84%

“…Plasma cells are not directly depleted by rituximab, because expression of CD20 is downregulated when B cells differentiate towards plasma cells, but formation of new plasma cells may be impaired by B cell depletion therapy. Although initial studies in pSS showed improvement of both subjective and objective parameters [4][5][6][7], two large placebo-controlled trials [8,9] did not confirm all promising results of the earlier studies. Possible explanations for this discrepancy are heterogeneity in patient characteristics, primary end points and background medication use, which will all be discussed in this review.…”

Section: Introductionmentioning

confidence: 80%

“…Therefore, these specified clinical settings for rituximab treatment were recently included in the clinical practice guidelines of the Sjögren's Syndrome Foundation [52]. In contrast with earlier findings, no significant effect on ESSDAI score was seen in the TEARS and TRACTISS trials [8,9]. Whereas a lack of effect in the TRACTISS study can be explained by relatively low baseline ESSDAI scores (mean 5.3 ± 4.7 for the rituximab group), the mean baseline score in the TEARS study was 10 ± 7.…”

Section: Effects On Extraglandular Manifestationsmentioning

confidence: 99%

“…Several open-label and randomized controlled trials have been performed to date, including two larger RCTs: the TEARS and TRACTISS trials [8,9]. In Tables 2 and 3, population characteristics and clinical outcomes of all prospective clinical trials reported in literature are summarized.…”

Section: Clinical Efficacy Of Rituximab In Primary Sjögren's Syndromementioning

confidence: 99%

“…St. Clair et al did not find an effect on UWS, but included patients with low to absent UWS at baseline, who therefore may have had irreversible destruction of glandular parenchyma [16]. Recently, Bowman et al showed that UWS of patients in the rituximab group of the TRACTISS trial remained stable, while the placebo group deteriorated [9].…”

Section: Effects On Exocrine Gland Function and Sicca Symptomsmentioning

confidence: 99%

See 4 more Smart Citations

The value of rituximab treatment in primary Sjögren's syndrome

Verstappen

Nimwegen

Vissink

et al. 2017

Clinical Immunology

View full text Add to dashboard Cite

Section: Effects On Exocrine Gland Function and Sicca Symptomsmentioning

confidence: 84%

Section: Introductionmentioning

confidence: 80%

Section: Effects On Extraglandular Manifestationsmentioning

confidence: 99%

Section: Clinical Efficacy Of Rituximab In Primary Sjögren's Syndromementioning

confidence: 99%

Section: Effects On Exocrine Gland Function and Sicca Symptomsmentioning

confidence: 99%

See 3 more Smart Citations

The value of rituximab treatment in primary Sjögren's syndrome

Verstappen

Nimwegen

Vissink

et al. 2017

Clinical Immunology

View full text Add to dashboard Cite

References

2021

Randomised Clinical Trials

View full text Add to dashboard Cite

Evaluating the role of alternative therapy in burn wound management: randomized trial comparing Moist Exposed Burn Ointment with conventional methods in the management of patients with second-degree burns. Medscape General Medicine, 3, 3. [2, 14] Ang ES-W, Lee S-T, Gan CS-G, Chan Y-H, Cheung Y-B and Machin D (2003). Pain control in a randomized controlled trial comparing Moist Exposed Burn Ointment (MEBO) and Randomised Clinical Trials: Design, Practice and Reporting, Second Edition. David Machin, Peter M. Fayers, and Bee Choo Tai.

show abstract

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

Hackett

Deane

Newton

et al. 2018

Arthritis Care & Research

Self Cite

View full text Add to dashboard Cite

ObjectiveFunctional 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.MethodsGroup concept mapping, a semiquantitative, mixed‐methods approach was used to identify and structure ideas from UK primary SS patients, adult household members living with a primary SS patient, 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.ResultsA 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.ConclusionOur data highlighted the fact that in addition to managing primary SS symptoms, 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.

show abstract

Randomized Controlled Trial of Rituximab and Cost‐Effectiveness Analysis in Treating Fatigue and Oral Dryness in Primary Sjögren's Syndrome

Abstract: The results of this study indicate that rituximab is neither clinically effective nor cost-effective in this patient population.

Cited by 200 publications

References 26 publications

The value of rituximab treatment in primary Sjögren's syndrome

The value of rituximab treatment in primary Sjögren's syndrome

References

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

Contact Info

Product

Resources

About