Impact of telemedicine on disease activity assessment: A case-crossover study nested within a cohort of patients with systemic lupus erythematosus.

INTRODUCTION: The utilisation of telemedicine has been rapidly growing among patients with rheumatic diseases, especially following the corona virus disease 2019 pandemic. Ease and convenience appear to dominate the reasons for this growth. However, the effects of this approach in patients with systemic lupus erythematosus (SLE) are yet to be revealed. In this study, we examined the effect of telemedicine on disease activity assessment and damage scores in patients with SLE. METHODS: This case-crossover study was nested within a national prospective cohort of patients with SLE in Saudi Arabia. Patients with SLE were included if they fulfilled the Systemic Lupus International Collaborating Clinics classification criteria between March 2020 and March 2021 and were assessed at three time points with 3 months between assessments, according to the standardised protocol of this cohort. Telemedicine was conducted for the first evaluation, while in-person assessments were used at the second and third visits. The primary outcome was the difference in the SLE disease activity index 2000 (SLEDAI-2K) score. The primary analysis was conducted using the repeated measure model and adjusted for potential confounders, including demographics, medications, and changes in steroid doses. Several sensitivity analyses were conducted to mitigate selection and time-varying confounders. RESULTS: A total of 92 participants were included in this study. Most patients were females (88%), with a mean (±standard deviation [SD]) age of 36 (±13) years. The mean (±SD) disease activity scores at baseline were as follows: SLEDAI-2K, 5 (±5); SLE responder index, 3.8 (±3.5); Systemic Lupus International Collaborating Clinics/American College of Rheumatology damage index, 1 (±1). The mean difference in SLEDAI-2K score was -1.641 (95% confidence interval -2.773 to -0.510, p = 0.005*) between telemedicine and follow-up visits. The results were consistent in all sensitivity analyses. CONCLUSION: We found that telemedicine assessment was associated with a much higher disease activity score than subsequent assessments, which may suggest an overestimation of disease activity and later assessment accuracy. Cautious adoption has been suggested for SLE patients with active disease.

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. A Delphi technique of consensus development was used involving an expert panel comprised of 10 rheumatologists, one dermatologist and one family physician. Based on the review of available published evidence and the opinions of clinical experts, key recommendations were developed. A consensus was achieved in defining the following: management guideline adaptable for Saudi Arabia, most useful screening tool, laboratory investigations, imaging tests and criteria for referring suspected PsA patients to a rheumatologist. In addition, an agreement was achieved in defining the T2T strategy and remission for the clinical management of PsA. Overall, these recommendations provide an evidence-based framework for the management of PsA patients in Saudi Arabia.

Disease burden and treatment challenges of psoriatic arthritis in Africa and the Middle East.

Psoriatic arthritis (PsA) is a chronic, inflammatory arthropathy occurring in up to 30% of patients with psoriasis, and is characterized by multiple manifestations including peripheral arthritis, enthesitis, dactylitis, spondylitis, and psoriatic skin and nail disease. This complex and heterogeneous disease is poorly understood and its diagnosis and treatment are suboptimal, particularly in Africa and the Middle East, where very few studies into the impact of PsA have been carried out. This article aims to highlight the disease burden of PsA in the region as well as to identify unmet clinical needs. A non-systematic review was carried out in the PubMed database and the most relevant publications were selected. Expert rheumatologists practicing in Africa and the Middle East provide an insight into the challenges of treating PsA in daily practice, along with recommendations for improvements.

Analysis of dedicated sacroiliac views to improve reliability of conventional pelvic radiographs.

Objective: To compare the antero-posterior (AP) pelvis view with the Ferguson view of the SI joint in order to resolve whether one modality has a clear advantage for grading of sacroiliitis. Methods: One hundred and nine patients fulfilling Assessment of SpondyloArthritis international Society (ASAS) criteria for axial spondyloarthritis who had AP pelvis and Ferguson views on the same day were identified from an axial spondyloarthritis clinic registry. Two rheumatologists independently scored the AP pelvis and Ferguson views according to modified New York (NY) criteria. Intra- and inter-reader agreements were obtained for both evaluations by using the kappa statistic and intraclass correlation coefficient (ICC). Any change in diagnostic category dictated by the Ferguson vs the AP pelvis views was also evaluated. Results: A total of 266 radiographs were read from 109 patients. Intra-observer reliability of the observers showed similar ICC scores; this was also reflected in the kappa for diagnosis of AS fulfilling modified NY criteria between the observers. The inter-rater agreement showed similar kappa values between the two modalities. When separately evaluating SI joints with score grading of 0-2, grade 2 showed the lowest kappa, reaching a low of 0.1 and 0.19 for the right SI joint for Ferguson and AP pelvis views, respectively. Both modalities were concordant diagnostically; reclassification from AS to non-AS and vice versa was in the range 5-11%. Conclusion: There was general agreement between the Ferguson and AP pelvis X-ray ICC and kappa scores. Either modality can be employed to evaluate the SI joint for sacroiliitis with the Ferguson view showing no clear superiority over the standard AP pelvis view.

Microbiome and probiotics: link to arthritis.

PURPOSE OF REVIEW: The gut microbiome plays an integral role in the development and maintenance of the host immune system. Expanding knowledge about this microbial microenvironment has raised the possibility of new treatments based on this knowledge. In this review, we describe the recent evidence of the impact of the gut microbiome on arthritis and possible novel therapeutic approaches to alter the gut flora. RECENT FINDINGS: Recent studies support the growing evidence of microbiome as a causative agent underlying certain rheumatic diseases like ankylosing spondylitis and rheumatoid arthritis. There is intriguing yet still inconclusive evidence to support the use of probiotics as a treatment for these diseases. SUMMARY: There is recently a new level of understanding how the microbiome interacts with the immune system. Gene-environment interaction is another important element that sets the stage for initiation of autoimmune disease, which calls for further investigation. Probiotics could be an appealing therapeutic strategy, but further interventional studies exploring the dynamic interaction of microbiome and probiotics are still needed.

Experiences of Dermatologists and Patients Regarding Psoriasis and Its Connection to Psoriatic Arthritis in Saudi Arabia.

Purpose: Psoriasis is a chronic, inflammatory, immune-mediated skin disease that has significant impact on a patient's quality of life, yet it remains challenging for dermatologists to successfully identify and manage. Without effective screening, diagnosis and treatments, psoriasis can potentially progress to psoriatic arthritis. A descriptive, observational cross-sectional study of Saudi Arabian dermatologists and patients with psoriasis was conducted to explore dermatologist and patient perspectives of psoriasis, including diagnosis, management, disease course and unmet needs. Patients and Methods: This study involved a quantitative questionnaire administered to 31 dermatologists and 90 patients with psoriasis at eight medical centers and was analyzed using descriptive statistics. Results: Dermatologists and patients perceived that psoriasis treatment was initiated promptly and that follow-up visits were sufficient. Their perspectives differed in the time to diagnosis and patient reaction, symptom severity, input into treatment goals and educational needs. The dermatologists' concerns about underdiagnosed psoriasis (13%) were primarily related to patient awareness (87%), physician awareness (58%), and the absence of a regular screening program (52%). Only 31% of patients with psoriasis were highly satisfied with their psoriasis treatment, with 78% experiencing unpleasant symptoms of pain or swelling in joints indicative of psoriatic arthritis. However, only 56% of these patients reported these symptoms to their physicians. When dermatologists were made aware of this difference, referrals to a rheumatologist increased. Conclusion: The study highlights the importance of strengthening psoriasis management by enhancing dermatologist referral and screening practices, adopting a multidisciplinary approach to care, and improving education and resources for physicians and patients. These results can help to inform the improvement of psoriasis screening, diagnosis and treatment strategies and ensure that expectations meet treatment outcomes. Further research exploring the dermatologist and patient perspectives of the disease pathway from psoriasis to psoriatic arthritis and tailor-made treatment approaches is recommended.

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. Although the prevalence of SpA varies across different populations and is correlated with HLA-B27 prevalence, the magnitude of SpA in the Saudi population has not been extensively evaluated. Few studies have investigated the impact of SpA on HRQoL and HCRU in Saudi Arabia and the Middle East. There is a need to study the cost-effectiveness of various SpA treatment strategies, including biologic disease-modifying anti-rheumatic drugs (bDMARDs), to prioritize healthcare spending in the Saudi healthcare system. Data on SpA in Saudi Arabia and the Middle East region are mainly based on expert views, with few population-based studies compared to other regions. Therefore, there is an imperative need to develop high-quality, national-level epidemiological studies that assess the following: (1) more accurate estimates of the current prevalence of SpA in Saudi Arabia, including the prevalence of axial SpA and psoriatic arthritis; (2) the phenotypes/clinical characteristics of SpA, including disease severity and extra-articular involvement; (3) the impact of SpA on the HRQoL of the patients and the factors that can predict the extent of impaired HRQoL in such population, which can represent the first step in developing psychological interventions that should be personalized to this patient population; (4) the impact of implementing formal assessment of disease activity on the management of the patients and, subsequently, their HRQoL; and (5) the HCRU and costs for patients with SpA, and how treatment patterns can affect this cost.

The Psoriatic Arthritis Experience in Saudi Arabia from the Rheumatologist and Patient Perspectives.

BACKGROUND: Psoriatic arthritis (PsA) is a musculoskeletal disease that adversely affects physical mobility and quality of life. It is challenging to manage because of the heterogeneous nature of the symptoms and the current treatment options. PURPOSE: To explore the patient and rheumatologist perspectives of PsA to help improve understanding of the disease experience and improve disease management. METHODS: A descriptive, observational cross-sectional study of Saudi Arabian dermatologists and rheumatologists and patients with psoriasis or PsA was conducted. Questionnaire data were collected from 31 dermatologists, 34 rheumatologists, 90 patients with psoriasis, and 98 patients with PsA and analysed using descriptive statistics. Here, data from rheumatologists and patients with PsA are presented. RESULTS: The results revealed similarities and differences in the rheumatologist and patient perspectives of PsA. Rheumatologists and patients agreed on the impact that PsA had on patients' quality of life and that more education was needed. However, they differed on several aspects of disease management. Rheumatologists estimated the time to diagnosis as four times shorter than what patients experienced. Patients accepted their diagnosis more than rheumatologists perceived them to; rheumatologists perceived patients to be worried or fearful. Patients perceived joint pain as their most severe symptom, in contrast to rheumatologists, who presumed skin appearance was the most severe symptom. Reported input into PsA treatment goals differed significantly. More than half of the rheumatologists reported equal patient-physician input into goal development as opposed to <10% of patients reporting the same. Almost half of patients reported no input into the development of their treatment goals. CONCLUSION: The management of PsA could benefit from enhanced screening and re-evaluation of what PsA outcomes have the most value to patients and rheumatologists. A multidisciplinary approach is recommended with increased patient involvement in disease management and individualized treatment options.

Efficacy of tofacitinib on enthesitis in patients with active psoriatic arthritis: analysis of pooled data from two phase 3 studies.

BACKGROUND: Tofacitinib is an oral Janus kinase inhibitor for the treatment of psoriatic arthritis (PsA). This post hoc analysis assessed tofacitinib efficacy on enthesitis by baseline location and severity, and impact on disease activity and patient-reported outcomes (PROs), in patients with PsA. METHODS: Data were pooled from two phase 3 studies (NCT01877668/NCT01882439) in patients with PsA receiving tofacitinib 5 or 10 mg twice daily to month (M)6 or placebo to M3. Endpoints were: change from baseline in Leeds Enthesitis Index (LEI) or Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC); proportions of patients with enthesitis, relapsed enthesitis after resolution, de novo enthesitis, low disease activity (LDA) or remission (minimal disease activity/very low disease activity; Psoriatic Arthritis Disease Activity Score; Disease Activity Index for Psoriatic Arthritis, and Composite Psoriatic Disease Activity in Psoriatic Arthritis); and PROs (Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F] total and arthritis pain Visual Analog Scale scores). Descriptive statistics were generated by visit and treatment. Change from baseline in PROs was evaluated by multivariate linear regression. RESULTS: Seven hundred ten patients from two studies were included: 479 had LEI > 0; 545 had SPARCC > 0; and 136 had LEI = 0 and SPARCC = 0 at baseline. At baseline, among patients with LEI > 0 or SPARCC > 0, mean LEI and SPARCC across treatments and enthesitis locations/severities ranged from 1.0-4.4 and 1.3-9.4, respectively. Across several baseline enthesitis locations/severities, changes from baseline in LEI and SPARCC up to M3 were greater with tofacitinib (-2.0-0.4 and -3.5-0.2) vs placebo (-|0.9-|0.4 and -1.5-1.1). Enthesitis at M6 was more common in patients with greater baseline enthesitis severity. At M6, ≤ 40% of patients with baseline LEI > 0 or SPARCC > 0 whose enthesitis had resolved by M1/M3 experienced a relapse, and < 14% of patients with baseline LEI = 0 and SPARCC = 0 had de novo enthesitis. LDA/remission rates generally increased with tofacitinib over time. Baseline LEI location was significantly associated with change from baseline in arthritis pain score, while baseline SPARCC severity was significantly associated with change from baseline in FACIT-F total and arthritis pain scores. CONCLUSION: Tofacitinib treatment resulted in improvements in enthesitis in patients with PsA, regardless of baseline location or severity. TRIAL REGISTRATION: NCT01877668;NCT01882439.

Prevalence of fatigue functional and social impairment among patients with rheumatic diseases compared to patients without: A cross-sectional comparison.

Rheumatic diseases (RD) are chronic diseases that significantly affect the lives of patients. Assessing health outcomes through a patient-reported outcome measurement information system (PROMIS) is essential for RD management. Moreover, these tend to be less favorable among individuals than among the rest of the population. This study aimed to compare PROMIS between RD patients and other patients. This cross sectional study was conducted in the year 2021. Information about patients with RD was obtained from the RD registry at King Saud University Medical City. Patients without RD were recruited from family medicine clinics. Patients were contacted electronically through WhatsApp© to complete the PROMIS surveys. We compared the individual PROMIS scores between the 2 groups using linear regression, adjusting for sex, nationality, marital status, education level, employment, family history of RD, income, and chronic comorbidities. There were 1024 individuals (512 with RD and 512 without RD). The most common RD was systemic lupus erythematosus (51.6%), followed by rheumatoid arthritis (44.3%). Individuals with RD reported significantly higher PROMIS T-scores for pain [ß = 6.2; 95% confidence interval (CI) = 4.76, 7.71] and fatigue (ß = 2.9; 95% CI = 1.37, 4.38) compared to those without RD. Moreover, RD individuals reported lower physical functioning (ß = -5.4; 95% CI = -6.50, -4.24) and social interaction (ß = -4.5; 95% CI = -5.73, -3.20). Patients with RD in Saudi Arabia, particularly those with systemic lupus erythematosus and rheumatoid arthritis, have significantly greater impairment in physical functioning and social interaction and report higher levels of fatigue and pain. Addressing and ameliorating these negative outcomes is necessary to improve quality of life.

The Journey to Diagnose Spondyloarthritis in Patients From Riyadh: A Cross-Sectional Study.

Introduction  Ankylosing spondylitis, now frequently referred to as spondyloarthritis (SpA), is a chronic inflammatory disease causing axial arthritis and inflammatory lower back pain resulting in the eventual impairment of spinal mobility. Moreover, its systemic complications include stiffness and inflexibility, restriction of lung capacity and function, eye inflammation, compression spinal fractures, and heart problems. Hence, early diagnosis and intervention play a key role in preventing acute complications and improving the quality of life. Objective  We aimed to estimate the average duration of diagnosis, the average number of doctors visited, and the association between the specialty of the first physician and the length of SpA diagnosis delay. Methods A cross-sectional retrospective study was conducted from November 2019 to April 2020 with patients from King Khalid University Hospital, Riyadh, Saudi Arabia. The patients were 18 years and older and diagnosed with SpA. Call interviews were conducted and patients' medical charts were reviewed. The data were analyzed using the Statistical Package for Social Sciences statistical software, version 23 (IBM Corp., Armonk, NY). Result  The total sample was 101 patients: 59 (58.4%) males and 42 (41.6%) females. The average duration from the onset of symptoms until seeking medical advice (lag 1) and from seeking medical advice until the definite diagnosis (lag 2) was 24.74 ± 48.13 and 16.16 ± 34.62 months, respectively. The average number of doctors visited between the first medical encounter and the final diagnosis was 3.56 ± 5.3. Patients who consulted rheumatologists as the first medical encounter showed less delay in diagnosis compared to patients who sought non-rheumatologists, such as orthopedists, emergency physicians, and general physicians (11.81 ± 33.35 months vs. 26.63 ± 44.28, 26.96 ± 44.88, and 44.33 ± 65.75 months, respectively). Conclusion  Patients with SpA who were not seen by rheumatologists took a longer period till the final diagnosis than those who visited rheumatologists earlier in the course of the disease. Therefore, more studies are required to define the exact factors leading to the delay.

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. Early diagnosis is important for reducing the risk of irreversible structural damage and disability. Management of axial spondyloarthritis is challenging in Saudi Arabia because of inadequate disease knowledge and the unavailability of local guidelines. Therefore, this expert consensus is intended to provide recommendations, including the referral pathway, the definition of remission and the treat-to-target approach, to all healthcare professionals for the management of patients with axial spondyloarthritis. A Delphi technique of consensus was developed by involving an expert panel of 10 rheumatologists, 1 dermatologist and 1 general physician. The experts offered consensus-based recommendations based on a review of available scientific evidence and clinical experience for the referral, screening and management of patients with axial spondyloarthritis.

The Delay of Diagnosis in Spondyloarthropathy Patients in a Tertiary Hospital in Saudi Arabia.

Objective Seronegative spondyloarthropathies (SpA) are a group of rheumatological disorders that share the common feature of being rheumatoid factor negative. Inflammation of the sacroiliac joint is considered the hallmark of ankylosing spondylitis (AS). On the other hand, psoriatic arthritis (PsA) affects patients with psoriasis. It is characterized by asymmetrical oligoarticular arthritis. Involvement of the distal interphalangeal joint is a unique feature of PsA. Enteropathic arthritis (EnA) involves the presence of inflammatory arthropathy in patients with inflammatory bowel disease (IBD). These diseases are strongly associated with the HLA-B27 gene. Although they are significantly disabling, their diagnosis has been frequently delayed. Early diagnosis is associated with early treatment, and thus better disease outcomes. The aim of this study was to evaluate the diagnostic delay (DD), that is, the duration between onset of symptoms and diagnosis, of SpA patients and its relation to the demographic characteristics, disease activity, measured by ankylosing spondylitis disease activity score (ASDAS) and bath ankylosing spondylitis disease activity index (BASDAI) scores, and the HLA-B27 status of Saudi SpA patients. Methods The data of 94 patients who were diagnosed with SpA were collected from medical records and from them personally. The data included patient demographics, age at diagnosis, delay of diagnosis, in years, disease activity (BASDAI and ASDAS scores), HLA-B27 status and C-reactive protein levels (CRP). The data were analyzed using Statistical Package for the Social Sciences for Windows version 21.0 (SPSS Inc., Chicago, IL, USA). Results 50% of patients were females. The mean DD was (mean ± SD) 4.98 ± 6.00 (range: 0-35). The average age of symptoms onset was 30.70 ± 11.30 (range: 8-59) and the average age at diagnosis was 35.65 ± 10.80 (range: 16-60). The mean BASDAI and ASDAS scores were 3.05 ± 2.21 and 2.29 ± 1.01, respectively. The majority of the patients had high disease activity (35.1 %). 25.0% were HLA-B27 positive. 83.7 % had normal CRP. There was no statistically significant difference between DD and gender, HLA-B27 status, ASDAS and BASDAI scores, and CRP. The DD was significantly higher in AS patients when compared to PsA (p-value= 0.048) and EnA patients (p-value < 0.0001). There was a statistically significant weak anticorrelation between DD and the age at symptoms onset in PsA patients (r-value= -0.39, p-value= 0.003). Age at diagnosis was statistically significantly higher in patients with PsA when compared to EnA. There was no correlation between DD and the disease activity in SpA patients. Conclusion The means of DD in AS, PsA, and EnA patients were 6.69 ± 5.83, 3.67 ± 6.42 and 2.00 ± 1.60, respectively. DD was greater in AS patients when compared to PsA and EnA patients. Early detection and referral to rheumatologists should be addressed, as early intervention is associated with favorable disease outcomes.

The treatment journey for patients with axial spondyloarthritis in North Africa and the Middle East: From diagnosis to management.

The management of axial spondyloarthritis (axSpA) is challenging worldwide, and the particular challenges shared by North Africa and the Middle East are mainly related to early diagnosis and standardized management. We believe there are several reasons for these challenges, including: (a) limited awareness of the disease manifestations and prevalence in the region among physicians; (b) the concept of nonradiographic axSpA, while accepted with some difficulty by the rheumatology community, may not be well understood by the referring primary care physicians; (c) access to, and training in magnetic resonance imaging varies greatly between countries in the North Africa and Middle East region, and this may have a large impact on early diagnosis; (d) country-specific treatment guidelines are unavailable; and (e) economic and cultural factors influence patients' attempts to seek and continue treatment. In this review, we will discuss the prevalence of axSpA in North Africa and the Middle East, as well as the challenges to diagnose and treat patients in this region. As rheumatologists practicing in North Africa and the Middle East, we also provide suggestions to assist physicians, other healthcare professionals, and researchers in facilitating early, accurate diagnosis and treatment of axSpA.

Risk Factors Associated with Methotrexate Intolerance in Rheumatoid Arthritis Patients.

BACKGROUND: Methotrexate (MTX) Intolerance Severity Score (MISS) has been previously validated in the Arabic language and has helped to detect high levels of intolerance in rheumatoid arthritis (RA) patients. The aim of the current study was to evaluate patient and disease characteristics associated with a high risk of MTX intolerance. MATERIALS AND METHODS: A cross-sectional interview-based survey was conducted using adult RA patients as a study group, who were visiting a specialized rheumatology clinic at King Saud University Medical City. The Arabic MISS was used in this survey. Statistical analyses were performed to understand associations between MTX-intolerant and MTX-tolerant patients. RESULTS: A total of 117 patients were involved in this study. Of those, 101 (86.3%) were females with a mean (SD) disease duration of 6.6 (5.7) years. The median (interquartile range (IQR)) Disease Activity Score-28 (DAS28) was 3.6 (3.6-4.1). MTX intolerance was observed in 55 (47%) patients. The most predominant component in patients with a positive test was the behavioral component. Intolerant patients had a higher median of pain (47.3 vs. 50.0; P = 0.010) and patient global assessment (50.0 vs. 60.0; P = 0.004) scales compared to those in tolerant patients. Additionally, MTX intolerance was associated with the female gender (adjusted odds ratio (AOR) 6.724; 95% CI 1.420, 31.843, P = 0.016), marital status (AOR 2.549; 95% CI 1.037, 6.270, P = 0.042) and DAS28 (AOR 1.612; 95% CI 1.032, 2.517, P = 0.036). There was no significant difference between the two groups in the remaining disease activity parameters, background therapies, seropositivity, and smoking status (P > 0.05). CONCLUSION: Patient characteristics, rather than disease activity, significantly impact MTX intolerance. Behavioral component is the main driver of intolerance. Intolerant patients have higher patient-reported outcomes. Qualitative studies are needed to explore causes and potential solutions to MTX intolerance.

Prevalence of methotrexate intolerance among patients with rheumatoid arthritis using the Arabic version of the methotrexate intolerance severity score.

AIM: Methotrexate (MTX) is the anchor drug for the treatment of rheumatoid arthritis (RA). MTX is associated with adverse events that limit its use. The MTX intolerance severity score (MISS) was developed to identify symptoms related to MTX use in juvenile idiopathic arthritis and RA patients. The aim of this study is to translate and validate the MISS in the Arabic language. METHODS: Forward and backward translation of the MISS were performed by two fluent Arabic translators and reviewed by three rheumatologists. Consecutive patients with RA who used MTX for ≥3 months were recruited from two tertiary care centers in Riyadh, Saudi Arabia. A test was considered positive if the patient scored ≥6 points. The internal consistency and stability of the items were evaluated using Cronbach's alpha and the test-retest method. RESULTS: A total of 185 patients were recruited. Of those patients, 158 (85.4%) were female. The mean (±SD) age and disease duration were 49.7 (±12.67) and 8.67 (±7.1) years, respectively. The mean Disease Activity Score of 28 joints was 3.2 (±1.3). Fifty-five (30%) patients were illiterate. Seventy-three (39.5%) patients had a positive MISS. Of those patients, 55 (75.3%) and 18 (24.7%) were using the oral and subcutaneous forms of MTX, respectively. The Arabic MISS had good internal consistency (Cronbach's alpha = 0.792) and a factorable study size for test-retest and factor analysis (Kaiser-Meyer-Olkin = 0.745). CONCLUSION: The Arabic MISS showed validity and good reliability in detecting MTX intolerance in RA patients. MTX intolerance is prevalent among RA patients. Larger studies are needed to confirm these findings.

Clinical Efficacy of Celecoxib Compared to Acetaminophen in Chronic Nonspecific Low Back Pain: Results of a Randomized Controlled Trial.

OBJECTIVE: In this randomized controlled trial, we compared the effect of celecoxib and acetaminophen on pain and magnetic resonance imaging (MRI) scores in patients with chronic nonspecific low back pain. METHODS: A total of 50 patients with chronic nonspecific low back pain were blindly randomized into 2 groups treated with celecoxib (200 mg twice daily) or acetaminophen (500 mg twice daily). Outcome measures included total back pain, nocturnal back pain, Oswestry Disability Index (ODI) scores, the Short Form 36 health survey to assess physical and mental status, and patient global assessment. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index, and Bath Ankylosing Spondylitis Metrology Index scores were also assessed before and after the therapy. The Spondyloarthritis Research Consortium of Canada scoring method was used to evaluate spinal MRI changes. RESULTS: Celecoxib showed a superior effect on total back pain, ODI, BASDAI, nocturnal back pain, and patient global assessment, compared to acetaminophen (P < 0.05). The number of patients with a significant change in back pain scales was higher in the celecoxib arm (ODI 34.8% versus 4.5%, nocturnal back pain 41.7% versus 9.1%, total back pain 33.3% versus 9.1%, and BASDAI 30.4% versus 9.1%; P < 0.01 for all). The responsiveness to celecoxib, calculated by Guyatt's Responsiveness Index, was 1.62, 1.28, 1.27, and 0.58 for the ODI, total back pain, BASDAI, and nocturnal back pain, respectively. The MRI scores for sacroiliac joints and spine showed no significant change with either treatment when compared with baseline values (P > 0.05). CONCLUSION: There was superior efficacy of celecoxib compared with acetaminophen in chronic nonspecific low back pain. Inflammatory lesions of sacroiliac joints and spine are commonly seen in nonspecific low back pain, but these lesions did not change with either celecoxib or acetaminophen treatments and were not associated with clinical response to either agent.

Fatigue in Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis: Analysis from a Longitudinal Observation Cohort.

OBJECTIVE: In this study, we aimed to address the prevalence of fatigue, its associated factors, and the effect of tumor necrosis factor inhibitors (TNFi) on this subgroup of patients in a large axial spondyloarthritis (axSpA) cohort. METHODS: The study included 681 patients [ankylosing spondylitis (AS) and nonradiographic axSpA (nr-axSpA)]. The Fatigue Severity Scale (FSS) and the Bath AS Disease Activity Index question 1 (BASDAI Q1) indices were used for fatigue assessment. Severe fatigue was defined as an FSS ≥ 4 or a BASDAI Q1 ≥ 5. Disease activity, function, and quality of life (QoL) measures were recorded. Patients who had been treated with TNFi were identified, and baseline and followup data were analyzed. RESULTS: Of the cohort, 67.3% had severe fatigue, and the prevalence was similar between AS (67.2%) and nr-axSpA (68.2%). Severely fatigued patients tended to have higher disease activity scores, increased acute-phase proteins, and decreased QoL measures. TNFi therapy was associated with improvement in disease activity, and although this treatment led to significantly decreased fatigue scores, this reduction was not optimal in the majority of patients with 80% continuing to have severe fatigue according to their posttreatment scores. Health Assessment Questionnaire, mean scores of BASDAI Q5 and Q6, and BASDAI enthesitis were independent predictors of fatigue severity. CONCLUSION: Fatigue is a common symptom in axSpA, and the burden of fatigue among patients with nr-axSpA is similar to that seen in AS. While biologics are effective in improving disease activity, their effect on fatigue is more limited. In axSpA, fatigue remains unresponsive to TNFi in nearly 80% of patients.