Ihab Ahmed

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.

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.

Hyperprolactinemia in Sjogren's syndrome: a patient subset or a disease manifestation?

OBJECTIVE To investigate the prevalence of hyperprolactinemia in patients with primary Sjogrens syndrome (SS), its clinical significance and its implication to our understanding of the disease pathogenesis. MATERIALS AND METHODS Forty-nine patients with primary SS (44 females and five males) age range 37-66 years were included in this study. All patients underwent clinical assessment for disease manifestations in addition to laboratory assessment for serum prolactin, sex hormones and immunological profile. Fifty healthy subjects (44 females and six males) of matched age were studied as control group. RESULTS The mean prolactin serum level was significantly higher in SS patients compared to the control group (P < 0.01). This significant difference was persistent after subgrouping the patients and the controls based on their menstrual history. Hyperprolactinemia (>20 ng/ml) was prevalent in 16.3% of SS patients. There was no correlation between serum prolactin levels and hormonal status, autoantibodies as well as systemic manifestations of the disease. CONCLUSION Patients with primary SS have moderately increased levels of prolactin. Hyperprolactinemia reflects disease pathology rather than being present in a subset of patients. The presence of elevated prolactin levels was not associated with hormonal status, clinical or immunological manifestations of primary SS.

Implementing Shared Decision Making In Clinical Practice: Outcomes ofa New Shared Decision Making Aid for Chronic Inflammatory ArthritisPatients

Abstract Objective: To develop and evaluate an evidence-based shared decision making (SDM) aid for patients with chronic arthritic conditions to inform them about the pros and cons of their treatment options and to help them make an informed shared decision. Methods: A multidisciplinary team defined criteria for the SDM as to design, medical content and functionality, particularly for elderly users. Development was according to the international standard (IPDAS). 174 patients with rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis, who were either treated or not yet treated, evaluated the tool, in a randomized controlled study, in comparison to control group composed of 171 patients treated according to standard methods. Results: The SDM aid was developed to offer information about the disease, the risks and benefits of treatment. 98% of the patients included reported comprehensibility of >85/100. There was no significant difference between the online and paper format SDM aids. The patients’ adherence to anti-rheumatic therapy was significantly (p<0.1) higher in the SDM group, whereas stopping DMARDs for intolerability was significantly (p<0.01) higher in the control group at 12 months of treatment. Conclusion: This evidence-based SDM aid for inflammatory arthritis patients, developed according to IPDAS criteria, was found to be a simple, user-friendly tool which can be implemented in standard clinical practice. It offered the chronic arthritis patients evidence-based information about the pros and cons of treatment options, improved patients’ understanding of the disease, communication with their treating clinician as well as ability to make an informed decision.

Towards Tailored Patient’s Management Approach: Integrating the Modified 2010 ACR Criteria for Fibromyalgia in Multidimensional Patient Reported Outcome Measures Questionnaire

Objectives. To assess the validity, reliability, and responsiveness to change of a patient self-reported questionnaire combining the Widespread Pain Index and the Symptom Severity Score as well as construct outcome measures and comorbidities assessment in fibromyalgia patients. Methods. The PROMs-FM was conceptualized based on frameworks used by the WHO Quality of Life tool and the PROMIS. Initially, cognitive interviews were conducted to identify item pool of questions. Item selection and reduction were achieved based on patients as well as an interdisciplinary group of specialists. Rasch and internal consistency reliability analyses were implemented. The questionnaire included the modified ACR criteria main items (Symptom Severity Score and Widespread Pain Index), in addition to assessment of functional disability, quality of life (QoL), review of the systems, and comorbidities. Every patient completed HAQ and EQ-5D questionnaires. Results. A total of 146 fibromyalgia patients completed the questionnaire. The PROMs-FM questionnaire was reliable as demonstrated by a high standardized alpha (0.886–0.982). Content construct assessment of the functional disability and QoL revealed significant correlation (p < 0.01) with both HAQ and EQ-5D. Changes in functional disability and QoL showed significant (p < 0.01) variation with diseases activity status in response to therapy. There was higher prevalence of autonomic symptoms, CVS risk, sexual dysfunction, and falling. Conclusions. The developed PROMs-FM questionnaire is a reliable and valid instrument for assessment of fibromyalgia patients. A phased treatment regimen depending on the severity of FMS as well as preferences and comorbidities of the patient is the best approach to tailored patient management.

Adaptation et validation d’une version arabe du questionnaire HAQ pour les patients atteints de polyarthrite rhumatoïde

Resume Objectif . – Tester la fiabilite et la validite d’une version traduite et modifiee de la version originale du questionnaire HAQ pour les patients atteints de polyarthrite rhumatoide. Methode. – Une cohorte de 184 patients atteints de polyarthrite rhumatoide et issus de differents pays arabes (Egypte, Arabie Saoudite, Soudan, Syrie, Bahrein, Koweit et Maroc) a ete constituee et ces patients ont ete inclus dans l’etude. Deux questions ont ete modifiees pour convenir a la culture arabe et pour adapter certains aspects qui se retrouvent plus souvent dans la culture arabe. Apres modification, traduction et retraduction du questionnaire, il a ete teste sur les patients selectionnes par rapport a sa coherence interne, sa fiabilite et sa validite en correlant le rendement du questionnaire aux autres marqueurs de l’activite de la maladie. Le questionnaire a ensuite ete a nouveau teste a 1 semaine d’intervalle pour evaluer sa reproductibilite. Les questions modifiees ont ete testees concernant leur loyaute par rapport au texte initial en comparant leurs correlations avec celles des items inchanges du questionnaire. Resultats. – Les 2 tests successifs ont mis en evidence une reproductibilite tres elevee avec un pourcentage de correspondance tres eleve et de forte valeur de kappa. La coherence interne a ete demontree par la forte valeur du alpha standardise (test de Cronbach) : 0,979, ce qui n’a mis en evidence aucune modification significative pour aucun des 20 items qui ont ete testes. Le questionnaire modifie a montre une validite tres elevee lorsque ces resultats ont ete correles avec d’autres parametres d’activite de la maladie. Cette correlation etait la plus importante avec le nombre d’articulations douloureuses, l’index articulaire de Ritchie, la raideur matinale, et l’echelle visuelle analogique et en dernier (mais toujours de facon significative) avec le facteur rhumatoide. Conclusion. – Le questionnaire HAQ Arabe est un outil fiable, valide qui peut etre utilise pour les patients arabes atteints de polyarthrite rhumatoide pour evaluer leurs troubles fonctionnels. Ses capacites de mesure sont comparables a des versions dans d’autres langues.