Is the patient-perceived impact of psoriatic arthritis a global concept? An international study in 13 Arab countries (TACTIC study).

The Psoriatic Arthritis Impact of Disease (PsAID-12) questionnaire, a recommended measure of patient-reported impact for psoriatic arthritis (PsA), was initially developed in Europe and may lack universal validity. Recognizing the need for a culturally appropriate tool for Arab patients, this study aimed to TranslAte, CulTurally adapt, and validate the PsAID in ArabIC (TACTIC). The PsAID-12 was translated into Arabic using a rigorous process of double translation, back-translation, and cognitive debriefing. The Arabic version was then validated through a study conducted in 13 Arab countries in 2022. Participants were consecutive literate adult patients diagnosed with PsA and fulfilling the CASPAR criteria. Collected data included PsAID-12, disease activity, and legacy patient-reported outcomes. Psychometric properties, such as internal consistency, construct validity, and test-retest reliability, were examined. Factors associated with high PsAID-12 total scores (> 4) were explored using multivariable binary logistic regression. A culturally adapted Arabic PsAID-12 questionnaire was achieved with minor rephrasing. The validation study included 554 patients from 13 countries (mean age 45 years, 59% females), with a mean PsAID score of 3.86 (SD 2.33). The Arabic PsAID-12 demonstrated excellent internal consistency (Cronbach's α = 0.95), and correlations with other measures ranged from 0.63 to 0.78. Test-retest reliability (N = 138 patients) was substantial (intraclass correlation coefficient, ICC 0.90 [0.86-0.93]; Cohen's kappa 0.80). Factors associated with a high PsAID score were disability (odds ratio, OR 3.15 [2.03-4.89]), depression (OR 1.56 [1.35-1.81]), widespread pain (OR 1.31 [1.12-1.53]), and disease activity (OR 1.29 [1.13-1.47]). Pain and fatigue were identified as the most impactful PsAID-12 domains for PsA patients. The Arabic PsAID is a valid and reliable measure that reflects the priorities of patients with PsA. PsAID scores correlated with disease activity and legacy outcome measures, as expected, indicating PsAID is a consistent measure of PsA impact across cultures. These findings highlight the potential of the Arabic PsAID in improving the care provided to Arabic-speaking patients worldwide.

Mean platelet volume to lymphocyte ratio and platelet distribution width to lymphocyte ratio in Iraqi patients diagnosed with systemic lupus erythematosus.

Introduction: The mean platelet volume to lymphocyte ratio (MPVLR) and platelet distribution width to lymphocyte ratio (PDWLR) have the potential to serve as markers of inflammation which may indicate disease activity. The mean platelet volume to lymphocyte ratio and PDWLR were assessed in patients with systemic lupus erythematosus (SLE) in this study. Material and methods: Sixty-two patients with systemic lupus erythematosus and 79 controls who were age and gender matched were included. Their sociodemographic information, as well as disease activity scores based on the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), disease duration, current medications, lymphocytes, platelets, platelet distribution width (PDW), and mean platelet volume (MPV), anti-nuclear antibody (ANA), anti-double stranded deoxyribonucleic acid (anti-dsDNA), and complement components (C3, C4) were recorded. The correlations of MPVLR and PDWLR with disease activity and some laboratory parameters were analyzed. Results: Lupus patients had significantly higher median (interquartile range) values for MPVLR and PDWLR than controls (5.69 [1.16-23.67] vs. 4.40 [2.78-11.93], p = 0.009) and 10.51 (2.87-79.37) vs. 5.21 (2.88-14.66), p < 0.001] respectively. According to the ROC curve, > 7.53 was the best PDWLR cut-off value for predicting SLE with a sensitivity of 71%, a specificity of 87% and an accuracy of 82.6%, whereas the optimum MPVLR cut-off value was > 6.46 with a sensitivity of 45.2%, a specificity of 88.9% and an accuracy of 76.8%. In addition, MPVLR had a significant positive correlation with SLEDAI (r = 0.34, p = 0.008). However, there was no significant correlation between PDWLR and SLEDAI (r = 0.23, p = 0.067). Furthermore, PDWLR had a significant positive correlation with PDW (r = 0.482, p < 0.001), while MPVLR had a significant negative correlation with C3 level (r = -0.260, p = 0.042). Both PDWLR and MPVLR were positively correlated with nephritis (r = 0.388, p = 0.002; r = 0.246, p = 0.038, respectively). Conclusions: The platelet distribution width to lymphocyte ratio can be considered as an assisting biomarker in the diagnosis of SLE with the other clinical and serological parameters. The mean platelet volume to lymphocyte ratio may be used in the evaluation of disease activity in SLE patients.

Niclosamide as an adjuvant to etanercept in treatment patients with active rheumatoid arthritis: an 8-week randomized controlled pilot study.

This study designed to identify the therapeutic efficacy of niclosamide (NCL) in Iraqi patients suffering from active rheumatoid arthritis (RA) who were using etanercept (ETN) for more than 3 months and still had high or moderate active RA. One hundred ten patients suffering from active rheumatoid arthritis (RA) who were using etanercept (ETN) for more than 3 months and still had high or moderate active RA were allocated randomly into two equal groups: one of them treated with 1000 mg/day NCL and the other treated with 1000 mg/day lactose in capsule dosage form. The study duration was 8 weeks. Clinical efficacy of the NCL was measured depending on scoring of the 28-joint Disease Activity Score (DAS28), simple disease activity index (SDAI), clinical disease activity index (CDAI), and Health Assessment Questionnaire Disability Index (HAQ-DI) at the baseline and at the end of the 8-week treatment period. Moreover, blood sample were taken from the patients at baseline and at after 8 weeks of treatment for measurement of the erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), interleukin 1ß (IL-1 ß), interleukin-6, tumor necrosis factor (TNF-α), intercellular adhesion molecule-1 (ICAM-1), vascular cell adhesion molecule-1 (VCAM-1), and E-selectin. At the end of the clinical study, patients had good response to NCL when added to the ETN with a high significant improvement in the SJC, TJC, DAS-28, CDAI, SDAI, and HAQ-DI compared to patients who were received placebo drug. In addition to that, 33% of patients achieved an ACR 20% response (ACR20) on NCL and ETN. Of these, 4% achieved ACR50 and another 4% achieved ACR70 response. While those group treated by placebo + ETN, 5% achieved ACR20 response and no one reached to ACR50 or ACR70 response. Twenty-seven percent of RA patients who have taken the NCL achieved moderate EULAR score while only 17% from the group that taken placebo with ETN achieved moderate response. On the other hand, no significant reduction was found in CRP, ESR, TNF-α, and IL-6, while IL-1 ß reduced significantly after treatment with NCL. Treatment with NCL also exerts a significant lowering in the serum level of the E-selectin, ICAM1, and VCAM1 when compared to their value in baseline level. In RA disease, the use of NCL as adjuvant with ETN has resulted in a marked reduction in clinical assessment scoring indices and significantly decreased the E-selectin, ICAM-1, and VCAM-1 with marked improvement in the quality of life of patients.

The adjuvant use of calcium fructoborate and borax with etanercept in patients with rheumatoid arthritis: Pilot study.

OBJECTIVE: This study was designed to evaluate the effects calcium fructoborate (CFB) and sodium tetraborate (NTB) as supplements in Iraqi patients with active rheumatoid arthritis (RA) maintained on etanercept. MATERIALS AND METHODS: A double-blind randomized placebo-controlled clinical trial with 60 days treatment period was carried out at Baghdad Teaching Hospital, Medical city, Baghdad, Iraq. Eighty RA patients were randomized into three groups to receive either 220 mg/day CFB, 55 mg/day NTB in capsule dosage form (equivalent to 6 mg elemental Boron), or placebo formula once daily. Only 72 patients completed the study. All patients were clinically evaluated utilizing DAS28-erythrocyte sedimentation rate (ESR), simple disease activity index-C-reactive protein (CRP), and clinical disease activity index scores at baseline, and at the end of the study. Venous blood was obtained at baseline and after 60 days, and utilized for the measurement of ESR, hemoglobin, in addition to evaluation of high-sensitivity CRP (hsCRP), tumor necrosis factor-α (TNF-α), interleukin-1α (IL-1α) and IL-6. RESULTS: After 60 days, both types of boron significantly improve the clinical scores, in association with significant decrease in the serum levels of ESR, hsCRP, IL-1α, IL-6, and TNF-α with remarkable superiority for calcium fructoborate (CFB) over sodium tetraborate (NTB), compared to baseline and placebo-treated group. CONCLUSION: The use of boron, as adjuvant with etanercept, has potentiated therapeutic outcomes in RA patients, and may be a new strategy to improve treatment, and avoid the problems associated with biologics utilized in RA treatment.

Pan Arab Osteoporosis Society Guidelines for Osteoporosis Management.

Osteoporosis is the most common bone disease in humans. With its related fragility fracture, it represents a major public health problem in our region, with a significant medical and socio-economic burden. The high prevalence rate of vitamin D deficiency, the increase in life expectancy, the low socioeconomic level and the significant restriction to access to health care in some countries represent the major causes for the increasing prevalence of osteoporosis and incidence of fragility fractures in the Arabic countries. Bone mineral density (BMD) assessment is the gold standard to diagnose osteoporosis. However, a clinical diagnosis of osteoporosis may be made in the presence of a fragility fracture, without BMD measurement. Dual energy x-ray absorptiometry (DXA) is the preferred method for screening bone mineral density. For screening site of measurement, DXA of hip and spine is suggested. BMD assessment is recommended in all women 65 years of age and older and men 70 and older regardless of risk factors. Younger subjects with clinical risk factors and persons with clinical evidence of osteoporosis or diseases leading to osteoporosis should also be screened. These guidelines are aimed to provide to health care professionals in the region of an updated process for the diagnosis and treatment of osteoporosis. It includes risk factors for osteoporosis and the indications for screening, diagnosis of osteoporosis, treatment of osteoporosis in postmenopausal and premenopausal women, and men; in addition to prevention and treatment of glucocorticoid-induced osteoporosis.

Silibinin Improves the Effects of Methotrexate in Patients with Active Rheumatoid Arthritis: Pilot Clinical Study.

OBJECTIVES: Our study sought to evaluate the effects of silibinin in patients with active rheumatoid arthritis (RA) treated with methotrexate (MTX). METHODS: We conducted a randomized multi-center, double-blind, placebo-controlled clinical trial over a 16-week treatment period at the Al-Sader and Baghdad Teaching Hospitals in Najaf and Baghdad, respectively. A total of 60 patients (30 of each sex) with active RA, already maintained on 12 mg MTX weekly for at least three consecutive months, were included in the study. Patients were randomly allocated to receive either 120 mg silibinin twice daily or a placebo, combined with their regular MTX regimen. The patients were evaluated by measuring disease activity score using the 28-joint Disease Activity Score, Simple Disease Activity Index, and Health Assessment Questionnaire-Disability Index scores at the start and end of the study. Blood samples were evaluated for the erythrocyte sedimentation rate (ESR), hemoglobin (Hb), high-sensitivity C-reactive protein (hs-CRP), creatine kinase (CK), anti-cyclic citrullinated peptide (CCP), and the serum cytokine levels of tumor necrosis factor (TNF)-α, interleukin (IL)-6, IL-8, IL-10, and IL-2. RESULTS: Silibinin significantly decreases the already elevated clinical scores compared to placebo treatment. ESR, IL-8, IL-6, TNF-α, anti-CCP, hs-CRP levels were significantly reduced. Additionally, the use of silibinin significantly increases Hb, IL-10, and IL-2 levels. CONCLUSION: Silibinin may improve the effects of MTX on certain biochemical and clinical markers of patients with active RA.

Adjuvant use of melatonin for treatment of fibromyalgia.

Fibromyalgia syndrome (FMS) is a chronic musculoskeletal disorder characterized by generalized muscular pain accompanied by fatigue and tenderness at specific anatomic sites called tender points. Although preliminary evidence indicates that melatonin may be effective in treating the pain associated with FMS, no definitive evidence supports this claim. This study was designed to evaluate the significance of using different doses of melatonin, alone or in combination with fluoxetine for the management of FMS. A double-blind, placebo-controlled clinical study was performed on 101 patients (95 women and 6 men) who fulfilled the criteria of the American College of Rheumatology (ACR) of FMS. The patients were randomized into four groups: group A (24 patients) treated with 20 mg/day fluoxetine alone; group B (27 patients) treated with melatonin 5 mg alone; group C (27 patients) treated with 20 mg fluoxetine plus 3 mg melatonin; group D (23 patients) treated with 20 mg fluoxetine plus 5 mg melatonin. Both drugs were given once daily in the morning and night time, respectively, for 8 wk. Each patient was clinically evaluated through direct interview with the patients using the Fibromyalgia Impact Questionnaire (FIQ) at zero time and after 8 wk. Using melatonin (3 mg or 5 mg/day) in combination with 20 mg/day fluoxetine resulted in significant reduction in both total and different components of FIQ score compared to the pretreatment values. In conclusion, administration of melatonin, alone or in a combination with fluoxetine, was effective in the treatment of patients with FMS.