Summing Up: Quality of Life in Chronic Immune-Mediated Inflammatory Diseases

Objectives: Myasthenia gravis (MG) is an immune-mediated neuromuscular disorder responsive to immunomodulatory treatments. 10–20% of MGs are not responsive to conventional first-line therapies. Here, we sought to investigate the efficacy and safety of rituximab therapy in the treatment of patients with refractory MG.Methods: In a 48-week, multicenter, open-labeled, prospective cohort setting, 34 participants with refractory MG were assigned to receive infusions of Zytux, which is a rituximab biosimilar, according to a validated protocol. Clinical, functional, and quality of life (QoL) measurements were recorded at baseline, and seven further visits using the Myasthenia Gravis Foundation of America (MGFA), Myasthenia Gravis Composite (MGC), Myasthenia Gravis Activities of Daily Living profile (MG-ADL), and Myasthenia Gravis Quality of Life (MGQoL-15) scales. Besides, the post-infusion side effects were systematically assessed throughout the study.Results: The correlation analysis performed by generalized estimating equations analysis represented a significant reduction of MGC, MG-ADL, and MGQoL-15 scores across the trial period. The subgroup analysis based on the patients' clinical status indicated a significant effect for the interaction between time and MGFA subtypes on MG-ADL score, MGC score, and pyridostigmine prednisolone dose, reflecting that the worse clinical condition was associated with a better response to rituximab. Finally, no serious adverse event was documented.Conclusions: Rituximab therapy could improve clinical, functional, and QoL in patients with refractory MG in a safe setting. Further investigations with larger sample size and a more extended follow-up period are warranted to confirm this finding.Clinical Trial Registration: The study was registered by the Iranian Registry of Clinical Trials (IRCT) (Code No: IRCT20150303021315N18).

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Immune Activation and Anemia Are Associated with Decreased Quality of Life in Patients with Solid Tumors

Journal of Clinical Medicine ◽

10.3390/jcm9103248 ◽

2020 ◽

Vol 9 (10) ◽

pp. 3248

Author(s):

Patricia Kink ◽

Eva Maria Egger ◽

Lukas Lanser ◽

Michaela Klaunzner ◽

Bernhard Holzner ◽

...

Keyword(s):

Quality Of Life ◽

Cancer Patients ◽

Solid Tumors ◽

Immune Activation ◽

Inflammatory Markers ◽

Mild Depression ◽

Tryptophan Degradation ◽

Immune Mediated ◽

Phenylalanine Metabolism

Anemia often coincides with depression and impaired quality of life (QoL) in cancer patients. Sustained immune activation can lead to the development of anemia. Furthermore, it also may go along with changes in tryptophan and phenylalanine metabolism. The aim of our pilot study was to study the relationship between anemia, immune-mediated changes in amino acid metabolism, and the QoL and mood of cancer patients. Questionnaires to measure QoL and depression were completed by 152 patients with solid tumors. Hemoglobin, parameters of immune activation as well as tryptophan and phenylalanine metabolism were determined in the patients’ sera. Anemic patients (51.7%) presented with higher inflammatory markers, and a higher tryptophan breakdown with lower tryptophan concentrations. They reported an impaired QoL and had higher depression scores. Patients with an impaired QoL (65.8%) also suffered from more fatigue and impaired physical, emotional, and social functioning. They, furthermore, presented with higher concentrations of inflammatory markers (C-reactive protein (CRP) and neopterin) as well as higher tryptophan degradation (in men) and higher phenylalanine concentrations (in women). Sixty-one patients (40.1%) had (mostly mild) depression. In these patients, a higher degree of Th1 immune activation was found. The results of our study suggest that cancer-related anemia goes along with an impaired QoL, which is also associated with immune-mediated disturbances of tryptophan and phenylalanine metabolism.

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Patient Satisfaction with Psoriasis Therapies: An Update and Introduction to Biologic Therapy

Journal of Cutaneous Medicine and Surgery ◽

10.1177/120347540400800502 ◽

2004 ◽

Vol 8 (5) ◽

pp. 310-320 ◽

Cited By ~ 2

Author(s):

Andrew Y. Finlay ◽

Jean-Paul Ortonne

Keyword(s):

Quality Of Life ◽

Patient Satisfaction ◽

Biologic Therapy ◽

Skin Condition ◽

Biologic Agents ◽

Immune Mediated ◽

Related Quality ◽

Health Related ◽

The Impact

Background: Psoriasis is a chronic, immune-mediated skin condition that often requires lifelong treatment. Many patients report dissatisfaction with traditional nonbiologic therapies because they are ineffective for their psoriasis, are associated with side effects, or impact negatively on quality of life. Objectives: The aim of this article is to review the effect on patient quality of life of traditional nonbiologic psoriasis therapies and to discuss the impact of biologic psoriasis therapies on patient satisfaction. Methods: A review of the literature is presented. Results: Traditional nonbiologic psoriasis therapies can negatively impact quality of life due to a variety of factors including inconvenience and toxicity. Biologic agents have been developed that target the immunopathogenesis of psoriasis. Based on favorable efficacy and safety results in clinical trials, some of these agents are now approved for clinical use. Evidence suggests that patients receiving biologic therapies experience significant improvements in health-related quality of life. Conclusion: Biologic agents offer new hope for patients with psoriasis that their chronic condition can be controlled in a manner that improves their quality of life and may lead to high levels of satisfaction with their treatment.

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Outcome selection for tissue-agnostic drug trials for immune-mediated inflammatory diseases: a systematic review of core outcome sets and regulatory guidance

Trials ◽

10.1186/s13063-022-06000-w ◽

2022 ◽

Vol 23 (1) ◽

Author(s):

Olalekan Lee Aiyegbusi ◽

Lavinia Ferrante di Ruffano ◽

Ameeta Retzer ◽

Philip N. Newsome ◽

Christopher D. Buckley ◽

...

Keyword(s):

Systematic Review ◽

Inflammatory Diseases ◽

Core Outcome ◽

Core Outcome Sets ◽

Regulatory Guidance ◽

Immune Mediated ◽

Outcome Selection ◽

Similarities And Differences ◽

Selection For

Abstract Background Tissue-agnostic drug development provides a paradigm shift in precision medicine and requires innovative trial designs. However, outcome selection for such trials can prove challenging. The objectives of this review were to: Identify and map core outcome sets (COS), across 11 immune-mediated inflammatory diseases (IMIDs) in order to facilitate the selection of relevant outcomes across the conditions for innovative trials of tissue-agnostic drug therapies. Compare outcomes or endpoints recommended by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) to identify and highlight similarities and differences. Methods The Core Outcome Measures in Effectiveness Trials (COMET), International Consortium for Health Outcomes Measurement (ICHOM), FDA and EMA databases were searched from inception to 28th December 2019. Two reviewers independently screened titles and abstracts of retrieved entries and conducted the subsequent full text screening. Hand searching of the reference lists and citation searching of the selected publications was conducted. The methodological quality of the included peer-reviewed articles was independently assessed by the reviewers based on the items of the COS–Standards for Development recommendations (COS–STAD) checklist. Core outcomes from the included publications were extracted and mapped across studies and conditions. Regulatory guidance from FDA and EMA, where available for clinical trials for the IMIDs, were obtained from their databases and recommendations on outcomes to measure directly compared. Results Forty-four COS publications were included in the final analysis. Outcomes such as disease activity, pain, fatigue, quality of life, physical function, work limitation/productivity, steroid use and biomarkers were recommended across majority of the conditions. There were significant similarities and differences in FDA and EMA recommendations. The only instance where either regulatory body directly referenced a COS was for jSLE—both referenced the Paediatric Rheumatology International Trials Organization (PRINTO) COS. Conclusions The findings from this systematic review provide valuable information to inform outcome selection in tissue-agnostic trials for IMIDs. There is a need for increased collaboration between regulators and COS developers and inclusion of regulators as key stakeholders in COS development to enhance the quality of COS. Trial registration Not registered.

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Effect of Omega-3 on Recurrent Aphthous Stomatitis and Improvement Quality of Life

International Journal of Dentistry ◽

10.1155/2021/6617575 ◽

2021 ◽

Vol 2021 ◽

pp. 1-9

Author(s):

Zahra Hadian ◽

Ali Akbar Moghadamnia ◽

Sohrab Kazemi ◽

Atena Shirzad

Keyword(s):

Quality Of Life ◽

Inflammatory Diseases ◽

Recurrent Aphthous Stomatitis ◽

Aphthous Stomatitis ◽

Omega 3 ◽

Mucosal Disease ◽

Related Quality ◽

Health Related ◽

Disease Questionnaire

Objective. Recurrent aphthous stomatitis is one of the most common chronic inflammatory diseases in oral mucosa. Beneficial effects of omega-3 supplements on some inflammatory diseases have been proved. The aim of present study was to evaluate the effect of omega-3 supplements in recurrent aphthous stomatitis management and improve oral health-related quality of life. Methods. In this double-blind clinical trial, 40 patients with minor recurrent aphthous stomatitis were randomly divided into case and control groups. The case group received 1000 mg capsules of omega-3, while the control group received placebo capsules for 6 months. The questionnaires of the ulcer severity score and the chronic oral mucosal disease questionnaire were filled by the patients in three steps, at the baseline session, after 3 months, and after 6 months. The data were analyzed by SPSS 22 software through ANOVA, Mann–Whitney, and chi-square tests. P < 0.05 was considered as significant. Results. In the omega-3 group, the ulcer severity score showed significant reduction by three-month and six-month follow-ups ( P < 0.0001 , P < 0.0001 , respectively). The mean score of the chronic oral mucosal disease questionnaire significantly improved by three-month and six-month follow-ups in the omega-3-receiving group. Conclusion. Use of omega-3 oral supplements decreased the severity of aphthous ulcer and improved oral health-related quality of life.

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Quality of Life in Painful Peripheral Neuropathies: A Systematic Review

Pain Research and Management ◽

10.1155/2019/2091960 ◽

2019 ◽

Vol 2019 ◽

pp. 1-9 ◽

Cited By ~ 13

Author(s):

Ayesha Girach ◽

Thomas Henry Julian ◽

Giustino Varrassi ◽

Antonella Paladini ◽

Athina Vadalouka ◽

...

Keyword(s):

Quality Of Life ◽

Literature Search ◽

Response To Treatment ◽

Independent Effect ◽

Peripheral Neuropathies ◽

Axonal Polyneuropathy ◽

Immune Mediated ◽

Pubmed Database ◽

Computer Based

Objective. Neuropathic pain is a common presenting complaint of patients with peripheral neuropathy (PN) and is considered one of the most disabling neuropathic symptoms, with detrimental effects on patients’ quality of life (QoL). The aim of this review was to overview the current literature that focuses on QoL in painful PN of various aetiologies. We sought to clarify the direct effect of pain and its treatment on patients’ QoL. Methodology. A systematic computer-based literature search was conducted using the PubMed database to search for papers on QoL in painful PN. Information was extracted regarding prevalence, demographics, and response to treatment where relevant. Results. We identified 66 articles eligible for inclusion. The vast majority of studies (n=47) focused on patients with diabetic PN. Other aetiologies of painful PN where QoL has been studied to date include gluten, immune-mediated, HIV, chemotherapy-induced, and chronic idiopathic axonal polyneuropathy. Pharmacological treatment is the mainstay in managing pain and has a direct positive and independent effect on the overall QoL. Other nonpharmacological approaches can also be of benefit, either alone or as adjuvant treatments, and are discussed. Conclusion. The findings demonstrate that QoL is impaired in painful PN and should not be neglected in clinical practice. Patients’ pain management and subsequent impact on QoL should routinely be assessed and monitored.

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Impact of red and processed meat and fibre intake on treatment outcomes among patients with chronic inflammatory diseases: protocol for a prospective cohort study of prognostic factors and personalised medicine

BMJ Open ◽

10.1136/bmjopen-2017-018166 ◽

2018 ◽

Vol 8 (2) ◽

pp. e018166 ◽

Cited By ~ 7

Author(s):

Robin Christensen ◽

Berit L Heitmann ◽

Karina Winther Andersen ◽

Ole Haagen Nielsen ◽

Signe Bek Sørensen ◽

...

Keyword(s):

Quality Of Life ◽

Cohort Study ◽

Treatment Outcomes ◽

Prospective Cohort Study ◽

Prospective Cohort ◽

Inflammatory Diseases ◽

Personalised Medicine ◽

Lifestyle Factors ◽

Chronic Inflammatory Diseases

IntroductionChronic inflammatory diseases (CIDs) are frequently treated with biological medications, specifically tumour necrosis factor inhibitors (TNFi)). These medications inhibit the pro-inflammatory molecule TNF alpha, which has been strongly implicated in the aetiology of these diseases. Up to one-third of patients do not, however, respond to biologics, and lifestyle factors are assumed to affect treatment outcomes. Little is known about the effects of dietary lifestyle as a prognostic factor that may enable personalised medicine. The primary outcome of this multidisciplinary collaborative study will be to identify dietary lifestyle factors that support optimal treatment outcomes.Methods and analysisThis prospective cohort study will enrol 320 patients with CID who are prescribed a TNFi between June 2017 and March 2019. Included among the patients with CID will be patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis), rheumatic disorders (rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis), inflammatory skin diseases (psoriasis, hidradenitis suppurativa) and non-infectious uveitis. At baseline (pretreatment), patient characteristics will be assessed using patient-reported outcome measures, clinical assessments of disease activity, quality of life and lifestyle, in addition to registry data on comorbidity and concomitant medication(s). In accordance with current Danish standards, follow-up will be conducted 14–16 weeks after treatment initiation. For each disease, evaluation of successful treatment response will be based on established primary and secondary endpoints, including disease-specific core outcome sets. The major outcome of the analyses will be to detect variability in treatment effectiveness between patients with different lifestyle characteristics.Ethics and disseminationThe principle goal of this project is to improve the quality of life of patients suffering from CID by providing evidence to support dietary and other lifestyle recommendations that may improve clinical outcomes. The study is approved by the Ethics Committee (S-20160124) and the Danish Data Protecting Agency (2008-58-035). Study findings will be disseminated through peer-reviewed journals, patient associations and presentations at international conferences.Trial registration numberNCT03173144; Pre-results.

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Information and resources important to the quality of life of people living with multiple sclerosis

Australian Journal of Rehabilitation Counselling ◽

10.1017/jrc.2020.17 ◽

2020 ◽

Vol 26 (2) ◽

pp. 92-104

Author(s):

Malachy Bishop ◽

Stuart Rumrill ◽

Bradley McDaniels ◽

Jian Li ◽

Robert Fraser ◽

...

Keyword(s):

Quality Of Life ◽

Multiple Sclerosis ◽

Psychosocial Health ◽

Physical And Mental Health ◽

Psychosocial Effects ◽

Immune Mediated ◽

Wide Range ◽

The Central Nervous System ◽

Types Of Information

AbstractMultiple sclerosis (MS) is a chronic, typically progressive immune-mediated disease characterized by inflammation and demyelination in the central nervous system (CNS), and is associated with a wide range of neurological, physical, and psychosocial effects. For people living with MS, access to relevant, timely, and accessible health information and resources may contribute to effective illness management, psychosocial health, and quality of life (QOL). In this study, we sought to increase understanding of the specific types of information most wanted by people with MS, as well as the sources and effects of this information. Specifically, we surveyed 748 adults with MS about (a) the sources from which they obtain information about MS, (b) the type of information that is most important in terms of improving their QOL, and (c) specific topics about which they would like to have more information, services, or resources. Content analysis of the qualitative results demonstrated the diversity of information sources accessed by people with MS and the importance of providing information through different formats and media. The participants prioritized information related to new MS medications and treatments, physical and mental health and wellness, and local opportunities for support. Implications for practicing rehabilitation counselors are discussed.

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