Expert Consensus Recommendations on a Biosimilars Value Framework for the Gulf Cooperation Council Countries.

Objective: This paper aims to develop a biosimilar value framework with local stakeholders in Gulf Cooperation Council (GCC) countries.

Methods: A convenience sample of ten key opinion leaders from the United Arab Emirates, Kingdom of Saudi Arabia, Kuwait, Oman and Qatar participated in an expert panel meeting in November 2022 that examined factors positively influencing biosimilar adoption in these countries. The discussion was structured around a conceptual biosimilar value framework and an overview of biosimilar policies as derived from a targeted review of the peer-reviewed and grey literature.

Exploring rheumatoid arthritis associated interstitial lung disease a retrospective study from two Saudi tertiary care centers.

Background: Interstitial lung disease (ILD) is an increasingly recognized complication of rheumatoid arthritis (RA) and is associated with significant morbidity and mortality. Many risk factors for RA-related ILD were reported. The current study aims to explore the features and risk factors of Saudi patients with RA-ILD.

Adverse Impact of Systemic Lupus Erythematosus on Pregnancy Outcomes: A Saudi Arabia Retrospective Multi-Center Study.

Objective: The current study aimed to determine the pregnancy outcomes complications in patients with SLE and its association with clinical, laboratory variables, disease activity, and medication use in the Saudi population, as well as pregnancy effect on disease activity.

Methods: A multicenter study included pregnant female patients with Systemic Lupus Erythematosus (SLE) from three tertiary centers in Saudi Arabia. The demographics, clinical, and laboratory variables, SLE disease activity index (SLEDAI), medication before, during, and after pregnancy, planned pregnancy, pregnancy-related outcomes, and complications in comparison to age-matched healthy female controls were noted.

Methodology for the adolopment of recommendations for the treatment of rheumatoid arthritis in the Kingdom of Saudi Arabia.

Background: Currently, there are no guidelines for the treatment of rheumatoid arthritis (RA) tailored to the context of the Kingdom of Saudi Arabia (KSA). Adaptation of guidelines accounts for contextual factors and becomes more efficient than de novo guideline development when relevant, good quality, and up-to-date guidelines are available. The objective of this study is to describe the methodology used for the adolopment of the 2021 American College of Rheumatology (ACR) guidelines for the treatment of RA in the KSA.

The Impact of Spondyloarthritis on Health-Related Quality of Life and Healthcare Resource Utilization in Saudi Arabia: A Narrative Review and Directions for Future Research.

Spondylarthritis (SpA) is an umbrella term that encompasses a wide range of rheumatological disorders. Several studies demonstrated that SpA is associated with increased healthcare resource utilization (HCRU) and a lower health-related quality of life (HRQoL). This review aimed to summarize the current literature regarding the multidimensional impact of SpA on HRQoL and HCRU in Saudi Arabia and explore the correlation of the extent of severity of SpA with HRQoL and HCRU.

Recommendations for the treatment of rheumatoid arthritis in Saudi Arabia: adolopment of the 2021 American College of Rheumatology guidelines.

Background: The 2021 American College of Rheumatology (ACR) rheumatoid arthritis (RA) guideline considers the specific context of the United States which differs from that of Saudi Arabia in many aspects that may impact recommendations. The objective of this project was to adapt a set of prioritized recommendations from the 2021 ACR guideline for the treatment of rheumatoid arthritis RA for the context of Saudi Arabia, by the Saudi Society for Rheumatology (SSR).

Methods: The process followed the GRADE-ADOLOPMENT methodology, and the reporting adhered to the RIGHT-Ad@pt checklist.

Perception of Biosimilar Biologics and Non-Medical Prescription Switching among Rheumatologists: A Saudi Society for Rheumatology Initiative.

Background: The aim of this study was to evaluate rheumatologists' perceptions of biosimilar biologics and Non-Medical Switching (NMS).

Methods: A cross-sectional survey was conducted among registered members of the Saudi Society for Rheumatology. The questionnaire focused on biosimilars and NMS.

Herpes zoster in SLE: prevalence, incidence and risk factors.

Objectives: This study aimed to evaluate the prevalence and incidence of herpes zoster (HZ) events and describe its associated factors in a study of patients with SLE.

Methods: 491 consecutive SLE participants were screened for HZ events using a patient-reported questionnaire to capture outcomes on pain and other characteristics associated with HZ events. Sociodemographic, clinical and laboratory measures were also analysed, and time-dependent Cox regression survival analyses were performed to investigate factors associated with HZ events.

Expert recommendations on early diagnosis and referral of axial spondyloarthritis in the Kingdom of Saudi Arabia.

Axial spondyloarthritis is a chronic inflammatory disorder that primarily involves the axial skeleton (sacroiliac joints and spine), causing stiffness, severe pain and fatigue. In some patients, definitive structural damage of sacroiliac joints is visible on imaging and is known as radiographic axial spondyloarthritis. Some patients do not have a clear radiographic damage of the sacroiliac joints, and this subtype is known as non-radiographic axial spondyloarthritis.

Consensus-based recommendations on the diagnosis, referral and clinical management of patients with psoriatic arthritis.

Psoriatic arthritis (PsA) is a highly heterogeneous disease with complex manifestations. Limited understanding of the disease and non-availability of local guidelines pose challenges in the management of PsA in Saudi Arabia. Therefore, this expert consensus is aimed to provide recommendations on the management of patients with PsA, including referral pathway, definition of remission and treat-to-target (T2T) approach.

Adverse Impact of Rheumatoid Arthritis on Pregnancy Outcomes: A Saudi Arabia Prospective Multicenter Study.

Background: Rheumatoid arthritis (RA) is associated with adverse pregnancy outcomes and postpartum complications, especially with severe disease activity.

Objective: The current study aimed to compare the pregnancy outcomes in patients with RA and healthy controls as well as to assess the impact of disease-related variables, medications and disease activity on pregnancy and neonatal-related outcomes in the Saudi population.

Methods: This prospective multicenter study included pregnant female patients with RA from three tertiary centers in Saudi Arabia.

Improving the understanding of originator and biosimilar biologics among healthcare providers in Saudi Arabia.

The loss of patentability of many originator biologics has led to the rapid introduction of biosimilar agents. The anticipated economic benefit of introducing such agent has been accompanied by vagueness surrounding their biotechnology, approval requirements, positioning in treatment paradigms and potential for adverse events. The Second Symposium on Biologics and Biosimilars "Beyond Clinical Practice" was held on 24th-26th January 2020 aiming at improving the understanding of these new agents in a diverse interactive conference and to guide stakeholders how to introduce biosimilars into clinical practice.

What is the prevalence of cognitive impairment in lupus and which instruments are used to measure it? A systematic review and meta-analysis.

Objectives: To systematically review the literature on the prevalence of Cognitive Dysfunction (CD) in SLE patients in studies that used a specified neuropsychological instrument.

Methods: This review was prepared with a protocol following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis-Protocols statement. Literature search in Ovid Medline, Embase, and Psyc INFO for articles on CD in adult SLE patients was conducted.

Prevalence and associated factors of resting electrocardiogram abnormalities among systemic lupus erythematosus patients without cardiovascular disease.

Background: Electrocardiogram (ECG) cardiovascular disease (CVD) abnormalities (ECG-CVD) are predictive of subsequent CVD events in the general population. Systemic lupus erythematosus (SLE) patients are vulnerable to CVD. We aimed to determine the prevalence of ECG-CVD in SLE patients and to examine the risk factors associated with ECG-CVD.

Recent advances in the biologic therapy of lupus: the 10 most important areas to look for common pitfalls in clinical trials.

Introduction: Systemic lupus erythematosus (SLE) is an autoimmune disease affecting different organs. The improved knowledge of the disease's pathogenesis has contributed to the emergence of immune targets and new biologic drugs directed at them. Although rheumatologists continue to use off-label biologics in SLE resistant to other immunosuppressants, only belimumab has been approved as a biological therapy since 2011.

Challenges of diagnosis and management of axial spondyloarthritis in North Africa and the Middle East: An expert consensus.

Axial spondyloarthritis (SpA) is a spectrum of inflammatory disease with stages characterized by both nonradiographic and radiographic sacroiliitis. Nonradiographic axial SpA is associated with health-related quality-of-life impairment and may progress to ankylosing spondylitis. Axial SpA has a low prevalence in some countries in North Africa and the Middle East, and pooling of data and resources is needed to increase understanding of the regional picture.

Clinical Assessment and Management of Spondyloarthritides in the Middle East: A Multinational Investigation.

Data on spondyloarthritis (SpA) from the Middle East are sparse and the management of these diseases in this area of the world faces a number of challenges, including the relevant resources to enable early diagnosis and referral and sufficient funds to aid the most appropriate treatment strategy. The objective was to report on the characteristics, disease burden, and treatment of SpA in the Middle East region and to highlight where management strategies could be improved, with the overall aim of achieving better patient outcomes. This multicenter, observational, cross-sectional study collected demographic, clinical, laboratory, and treatment data on 169 consecutive SpA patients at four centers (Egypt, Kuwait, Qatar, and Saudi Arabia).

2015 Guidelines for Osteoporosis in Saudi Arabia: Recommendations from the Saudi Osteoporosis Society.

Background And Objectives: To provide guidelines for medical professionals in Saudi Arabia regarding osteoporosis.

Design And Settings: A panel of 14 local experts in osteoporosis assembled to provide consensus based on the strength of evidence and expert opinions on osteoporosis treatment.

Patients And Methods: The Saudi Osteoporosis Society (SOS) formed a panel of experts who performed an extensive published studies search to formulate recommendations regarding prevention, diagnosis, and treatment of osteoporosis in Saudi Arabia.

Profile of epratuzumab and its potential in the treatment of systemic lupus erythematosus.

Management of systemic lupus erythematosus (SLE) represents a fascinating, emerging field. Research has recently provided us with a better understanding of the immunologic alterations of SLE, leading to the creation of immunomodulatory agents designed to disrupt specific cell targets and pro-inflammatory pathways. Despite the improvement in the prognosis of SLE in the last 50 years with the use of immunosuppressive therapy such as cyclophosphamide and mycophenolate mofetil, cytotoxicity remains a major complication of these medications and the need for more specific targeted immunotherapy is increasing.

Loss-of-function variant in DNASE1L3 causes a familial form of systemic lupus erythematosus.

Systemic lupus erythematosus (SLE) is a complex autoimmune disease that causes substantial morbidity. As is typical for many other multifactorial disorders, much of the heritability of SLE remains unknown. We identified a rare autosomal recessive form of SLE, in which autozygome analysis revealed a null mutation in the DNASE1L3 gene.

Mixed connective tissue disease: the King Faisal Specialist Hospital experience.

Background: The aim of this study was to assess the clinical presentation, complications and serological analysis of mixed connective tissue disease (MCTD) at King Faisal Specialist Hospital & Research Centre (KFSH&RC), and to determine the long-term clinical and immunologic outcomes.

Patients And Methods: This was a retrospective study with prospective follow-up of 18 patients with MCTD who were followed at KFSH&RC between 1982 and 1999.

Results: The age at onset of the disease ranged from 6 to 44 years, with a mean age of 17.

Thalidomide for treatment of severe generalized discoid lupus lesions in two patients with systemic lupus erythematosus.

We describe 2 patients with systemic lupus erythematous whose widespread discoid lupus erythematosus was unresponsive to systemic steroids and antimalarial agents. They showed dramatic improvement to thalidomide at a dose of 300 mg/d, with maximum benefit achieved within 15 weeks of therapy. Dosages of 50 to 100 mg/d were effective in maintaining remission for 1 year.