Maha El Gaafary

The Gastrointestinal Safety and Effect on Disease Activity of Etoricoxib, a Selective Cox-2 Inhibitor in Inflammatory Bowel Diseases

BACKGROUND:While traditional nonsteroidal antiinflammatory drugs (t-NSAIDs) are relatively contraindicated in patients with inflammatory bowel disease (IBD) for fear of disease aggravation, controlled clinical trials showed that cyclo-oxygenase-2 inhibitors have fewer gastrointestinal side effects than the t-NSAIDs. Etoricoxib is a new antiinflammatory inhibitor that has high Cox-2 selectivity.OBJECTIVES:To assess the safety of etoricoxib and effect on disease activity in patients with IBD in a multicenter, double-blind, placebo-control study.METHODS:Study group included 76 patients suffering from IBD (ulcerative colitis (UC) (38), and Crohns disease (CD) (38)). The control group included 70 patients known to have UC (35) and Crohns disease (CD) (35).Patients of both groups were referred to the rheumatology clinic for rheumatic manifestations that require antiinflammatory therapy and were intolerable to the t-NSAIDs. The level of the IBD activity at the baseline visit, when drug/placebo therapy was initiated, was scored for all subjects included in the study. In the study group the dose of etoricoxib ranged from 60 to 120 mg tablet once a day according to their rheumatic condition. The control group received a placebo tablet once a day. Adverse events related to the use of the study medication in 1 and 3 months time were documented. Etoricoxib/placebo therapy was stopped once the patient experience flare up of their IBD.RESULTS:There was no significant difference between the patients and the control groups. After 3 months of etoricoxib therapy, 8 of 76 (10.53%) of the study group had aggravation of their underlying IBD and stopped the drug therapy, while 68 of 76 (89.5%) completed the study. The mean disease activity index before etoricoxib therapy was 1.15 + 0.794, whereas it was 1.19 + 0.683 after therapy. In the control group 8 of 70 (11.43%) experienced exacerbation of their symptoms while 62 of 70 (88.6%) completed the study.In the control group the mean disease activity before treatment was 1.16 + 0.253, whereas after placebo therapy was 1.20 + 0.481. 67 of 76 (88.2%) of the study group and 62 of 70 (88.6%) of the control group gave history of using t-NSAID therapy in addition to PPI that caused flare up of their IBD. For the patients who had to stop their drug therapy, all the adverse events occurred in the first month of drug/placebo challenge and all symptoms were reversible.CONCLUSION:Etoricoxib therapy is safe and beneficial in most patients with IBD treatment with etoricoxib was not associated with exacerbation of the underlying IBD- and GI-related complications.

Montreal Cognitive Assessment Arabic version: Reliability and validity prevalence of mild cognitive impairment among elderly attending geriatric clubs in Cairo

Aim:  Mild cognitive impairment (MCI) is a clinical label which includes elderly subjects with memory impairment and with no significant daily functional disability. MCI is an important target for Alzheimers dementia prevention studies. Data on the prevalence and incidence of MCI varies greatly according to cultural difference. The first aim of this study was to assess the reliability and validity of Montreal Cognitive Assessment (MoCA) Arabic version in MCI detection. The second was to determine the prevalence of MCI among apparently healthy elderly people attending geriatric clubs in Cairo.

Cross-cultural adaptation and validation of an Arabic Health Assessment Questionnaire for use in rheumatoid arthritis patients

OBJECTIVE To test the reliability and validity of a modified and translated version of the original Health Assessment Questionnaire (HAQ) on patients with rheumatoid arthritis (RA). METHOD A cohort of 184 RA patients from different Arabic countries (Egypt, Saudi Arabia, Sudan, Syria, Bahrain, Kuwait and Morocco) were recruited and asked to participate in the study. Two questions had been changed to suit the Arabic culture and to tackle some aspects that are commoner to be performed in the Arabic culture. After modification, translation and retranslation of the questionnaire, it was administered to the selected patients and tested for internal consistency, reliability and construct validity by correlating the yield of the questionnaire with other disease activity parameters. The questionnaire was administered again after a 1-week interval for evaluation of the reliability of this test. The modified questions were tested for their loyalty to the principal component and comparing their correlation with that of the other unchanged items. RESULTS Test-retest showed strong reliability with a high percentage of agreement and high values for Kappa. Internal consistency showed a high value for standardized alpha (Cronbachs): 0.979 that did not show any significant change if any of the 20 items had been eliminated. The modified questionnaire had shown a strong validity when correlating its results with other disease activity parameters. This correlation was the strongest with tender joint count (TJC), Ritchie articular index (RAI), morning stiffness (MS) and visual analogue scale (VAS) and the least (but still significant) with rheumatoid factor (RF). CONCLUSION The Arabic HAQ is a reliable and valid instrument that can be self-administered to Arabic RA patients to evaluate their functional disability. Its measurement properties were comparable to versions in other languages.

Safety of etoricoxib, a specific cyclooxygenase-2 inhibitor, in asthmatic patients with aspirin-exacerbated respiratory disease

BACKGROUND Treatment of rheumatic conditions is limited in patients with asthma owing to concerns of nonsteroidal anti-inflammatory drugs potentially provoking asthma. Cross-sensitivity to all anti-inflammatory drugs that inhibit cyclooxygenase enzymes occurs in these individuals. OBJECTIVES To study the safety of etoricoxib, a specific cyclooxygenase-2 inhibitor, and to determine whether it cross-reacts with asthma in patients with aspirin-exacerbated respiratory disease (AERD). METHODS This study included 77 patients who had experienced asthma induced by aspirin and at least 1 other nonsteroidal anti-inflammatory drug. Baseline evaluation included blood pressure measurement, nasal examination, spirometry, and peak expiratory flow rate measurement. Patients were given placebo the first day and then were challenged with once-daily etoricoxib in 3 different doses: 60 mg on day 2, 90 mg on day 3, and 120 mg on day 4. If no evidence of intolerance was seen, each patient was rechallenged with 60 or 90 mg of etoricoxib once daily (according to the rheumatic condition) 7 days later. Reassessment of the baseline measurements was performed daily from day 1 to day 4 after the initial challenge, on day 7 after rechallenge, and after 1 month of drug intake. If the patient developed any mucosal or skin reaction, hypotension, upper or lower airway obstruction, conjunctival reaction, or laryngeal edema during the challenge test, it was considered a positive response. RESULTS Etoricoxib was well tolerated, without any signs of immediate or delayed hypersensitivity in aspirin- and nonsteroidal anti-inflammatory drug-induced asthmatic patients. None of 77 study patients experienced any symptoms or developed dyspnea, change in nasal examination, significant variation in peak expiratory flow rate greater than 20%, or decline in forced expiratory volume in 1 second greater than 15% during etoricoxib challenge. The exact 1-sided confidence interval for the probability of etoricoxib inducing cross-reactions in patients with AERD was 0% to 2%. CONCLUSIONS These results confirm the lack of cross-reactivity between specific cyclooxygenase-2 inhibitors and aspirin in AERD. Etoricoxib was safe for treating inflammation in patients with AERD.

Defining disease status in ankylosing spondylitis: validation and cross-cultural adaptation of the Arabic Bath Ankylosing Spondylitis Functional Index (BASFI), the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and the Bath Ankylosing Spondylitis Global score (BASG)

The Bath Ankylosing Spondylitis Functional Index (BASFI), disease activity index (BASDAI), and Global assessment (BASG) are the most commonly used instruments to assess patients suffering from ankylosing spondylitis (AS). The aim of this study was to translate, adapt, and validate these instruments into the Arabic language. Seventy-three AS patients were included in this study. One question in the BASFI questionnaire was changed to suit the Arabic culture. Also, the VAS in the questionnaires was transformed to numerical rating scales from 0 to 10. After modification, translation, and retranslation of the questionnaires, it was administered and tested for internal consistency, reliability, and construct validity. Magnetic resonance imaging (MRI) of the spine and sacroiliac joints was carried out for 69 patients; scores for disease activity and chronicity were also assessed. The adapted and translated questionnaires demonstrated acceptable comprehensibility scores with a mean of 9.3. Intraclass correlation coefficients for reliability and internal consistency was 0.973 for BASG, whereas standardized alpha ranged between 0.807 and 0.976. The modified item 9 in the BASFI demonstrated a good correlate to the principal component (0.883). When validated, all three questionnaires showed a significant correlation with enthesitis, BAS-radiology index, MRI imaging scores for activity and chronicity, C-reactive protein (CRP), and morning stiffness duration. The Arabic version of the BASFI, BASDAI, and BASG, showed adequate reliability and validity in patients with AS. The measurement properties were comparable to versions in other languages indicating that the questionnaires can be used for evaluation of AS Arabic-speaking patients.

Elder mistreatment in a rural area in Egypt

Aim:  Mistreatment of the elderly is a hidden problem frequently cloaked under the shroud of family secrecy. The aim of the present study was to determine the extent of mistreatment of older people living at their homes in the rural area of Mansoura city, Dakahlia governorate, Egypt.

Ultrasound assessment of the median nerve: a biomarker that can help in setting a treat to target approach tailored for carpal tunnel syndrome patients

Ultrasonography (US) is a valuable tool for confirming the diagnosis of carpal tunnel syndrome (CTS) as it enables the detection of changes in the median nerve shape and rule out anatomic variants as well as space-occupying lesions such as ganglion cysts or tenosynovitis. This work was carried out aiming at: 1. Ultrasonography assessment of the median nerve and its neurovascular blood-flow in CTS patients before and after management. 2. Verify the possibility of using baseline US parameters as a biomarker to predict likely outcomes and frame a treatment plan for CTS patients.233 CTS subjects diagnosed based on clinical and electrophysiological (NCS) testing were included in this work. US measures at the tunnel inlet included: cross sectional area, flattening ratio and neural Power Doppler (PD) signals. Patients who had severe NCS outcomes or neurological deficit were referred for open surgical decompression; the remaining patients were given the choice of either conservative or surgical management. The main outcome variable was improvement >70% in CTS symptoms. Assessments were carried out at baseline, 1-week, 1-month and 6-months post treatment. Results revealed an inverse relation between the neural vasculature and CTS severity defined by NCS (r = − 0.648). In CTS cases treated conservatively, the US measures started to improve within 1-week, whereas in the surgically treated cohort there was an initial phase of post-operative nerve measures increase, before settling at 1-month time of follow-up. The risk of poor outcomes was significantly higher (RR 3.3) in patients with high median nerve flattening ratio. This risk was most marked in the cohort with nerve flattening associated with longer duration of illness (RR 4.3) and low PD signal (RR 4.1). The results revealed that in addition to the diagnostic value of US in CTS, the detection of increased median nerve neuro-vasculature has a good prognostic value as an indicator of early median nerve affection.

Towards a multidimensional patient reported outcome measures assessment: development and validation of a questionnaire for patients with ankylosing spondylitis/spondyloarthritis.

OBJECTIVE To assess the validity, reliability and responsiveness to change of a patient self-reported questionnaire that can assess construct outcome measures of patients with ankylosing spondylitis (AS)/spondyloarthritis. METHODS The questionnaire was developed by integrating information obtained from patients suffering from AS/spondyloarthritis based on the Rasch model. The questionnaire includes assessment of functional disability, quality of life, VAS for spinal pain, joint pain, global status, fatigue, duration of morning stiffness, review of the systems, falls and cardiovascular risks, self-helplessness as well as self-reported joint and soft tissue pain. The questionnaire was completed by 267 consecutive patients with AS (124) and spondyloarthritis (143). RESULTS The PROMs questionnaire was reliable as demonstrated by a high-standardized alpha. The questionnaire items correlated significantly (p<0.01) with clinical parameters of disease activity. Patient reported tender joints and enthesitis scores correlated significantly with the physicians scores (correlation coefficient 0.848 and 0.821 respectively). Changes in functional disability, quality of life as well as self-helplessness scores showed significant (p<0.01) variation with diseases activity status. The PROMs questionnaire showed also a high degree of comprehensibility (9.3). CONCLUSION The developed PROMs questionnaire is a reliable and valid instrument for assessment of patients suffering from AS and spondyloarthritis. Being short, rapid and comprehensive, this adds more to its applicability. The data support the value of completion of the simple two pages patient questionnaire, which provides a quantitative written documented record by the patient, at each visit to the rheumatologist.

Evaluating changes in health status: sensitivity to change of the modified Arabic Health Assessment Questionnaire in patients with rheumatoid arthritis.

OBJECTIVE To test the correlation between clinical improvements in patients with rheumatoid arthritis (RA) as defined by the American College of Rheumatology (ACR) response criteria and functional improvements as assessed by functional measures in the modified Arabic version of the Health Assessment Questionnaire (Arabic-HAQ) and to estimate the sensitivity to change of the Arabic-HAQ, in a prospective study. METHODS Eighty-two patients with active RA were given methotrexate and followed up prospectively for 12 months. ACR response rates and score improvements on the modified Arabic-HAQ were compared. RESULTS The Arabic-HAQ scores showed significant sensitivity to change after 6 and 12 months and were significantly correlated with the ACR response. Percentages of agreement with ACR response levels were high after 6 months and higher still after 12 months. Standardized effect sizes were 2.34 and 2.84 after 6 and 12 months, respectively. Relative efficiency of the total Arabic-HAQ score in relation to the tender joint count was greater than 1. CONCLUSION The Arabic-HAQ is valid and sensitive to functional status changes in patients with RA. The results are comparable to those of the original HAQ. Thus, the Arabic-HAQ can be used to evaluate treatments and to identify changes that are important to RA patients.

Validity of the Developed Arabic Multidimensional Health Assessment Questionnaire for use in standard clinical care of patients with rheumatic diseases

Objective:  To assess the validity, reliability and comprehensibility of the Developed Arabic Multidimensional Health Assessment Questionnaire (Arabic‐MDHAQ) for use in standard clinical care of patients with rheumatic diseases.