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עמוד בית
Thu, 13.06.24

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March 2023
Yehudit Nahum, Iftach Sagy, Yarden Cohen, Elisheva Pokroy-Shapira, Mahmoud Abu-Shakra, Yair Molad

Background: Epidemiological studies have shown a connection between ethnic origin and the incidence and outcome of systemic lupus erythematosus (SLE).

Objective: To evaluate the SLE outcomes among Ashkenazi Jews, non-Ashkenazi Jews, and Arabs.

Methods: We conducted a retrospective study of patients who were diagnosed with SLE and followed in lupus clinics at two large tertiary medical centers. The data were obtained from patient medical records. Patients were stratified into three ethnic origins: Ashkenazi Jews, non-Ashkenazi Jews, and Arabs. The primary outcomes were all-cause mortality, development of end-stage kidney disease (ESKD), and Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2K ≤ 4 at last visit.

Results: We included 570 patients in this study. The Arab group showed the highest number of SLE classification criteria at diagnosis and last encounters compared to non-Ashkenazi and Ashkenazi Jewish groups (6.0 vs. 5.0 and 4.0, respectively at diagnosis, P < 0.001; 8.0 vs. 7.0 and 6.0 at last visit, P = 0.01). In multivariate models, Arab patients had three times higher risk of all-cause mortality than Ashkenazi Jews (hazard ratio 2.99, 95% confidence interval [95%CI] 1.32–6.76, P = 0.009). ESKD was similar among the study groups. Low disease activity (SLEDAI 2K ≤ 4) at last visit was lower in the Arab group than the Ashkenazi Jews (odds ratio 0.50, 95%CI 0.28–0.87, P = 0.016), depicting a medium-to-high disease activity among the former.

Conclusions: Physicians should consider the influence of the ethnicity of the SLE patient when deciding on their care plan.

September 2020
Pnina Langevitz MD, Merav Lidar MD, Itzhak Rosner MD, Joy Feld MD, Moshe Tishler MD, Howard Amital MD, Suhail Aamar MD, Ori Elkayam MD, Alexandra Balbir-Gurman MD, Mahmoud Abu-Shakra MD, Dror Mevorach MD, Oded Kimhi MD, Yair Molad MD, Ana Kuperman MD and Sharon Ehrlich MD

Background: Tocilizumab is an interleukin 6 (IL-6) receptor antagonist used treat moderate to severe active rheumatoid arthritis (RA). Both intravenous (IV) and subcutaneous (SC) routes are approved for the treatment of adults with RA.

Objectives: To evaluate SC tocilizumab in a real-life clinical setting.

Methods: Our study was a multi-center, open-label, single-arm study. Participants were adults with a diagnosis of active RA, previously treated with disease-modifying antirheumatic drugs (DMARDs), with or without biologic agents. Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or DMARDs for 24 weeks. Efficacy, safety, and immunogenicity were assessed.

Results: Treatment of 100 patients over 24 weeks resulted in improvement in all efficacy parameters assessed: Clinical Disease Activity Index, Disease Activity Score using 28 joint counts and erythrocyte sedimentation rate, American College of Rheumatology response scores, Simplified Disease Activity Index, tender and swollen joint counts, and patient-reported outcomes including fatigue, global assessment of disease activity, pain, and Health Assessment Quality of Life Disease Index. Improvement was achieved as early as the second week of treatment. There were 473 adverse events (AEs)/100 patient-years (PY) and 16.66 serious AEs/100 PY. The most common AEs were neutropenia (12%), leukopenia (11%), and increased hepatic enzymes (11%). Of a total of 42 PY, the rates of serious infections and AEs leading to discontinuation were 4.8, and 11.9 events/100 PY, respectively.

Conclusions: The safety, tolerability, and efficacy profile of tocilizumab SC were comparable to those reported in other studies evaluating the IV and SC routes of administration.

 

April 2016
Mahmoud Abu-Shakra MD

Physical, mental and social well-being are important outcomes in patients with chronic rheumatic diseases, including systemic lupus erythematosus (SLE). The MOS SF-36 and the WHO QoL Bref are appropriate for assessing quality of life (QoL) in patients with SLE.  The QoL of patients with SLE is impaired compared with that of controls. Fibromyalgia adversely affects the QoL of SLE patients. Women with SLE had significantly lower scores on subscales of the sense of coherence (SoC) compared with matched controls. This reduced SoC in SLE women represents impaired adaptive coping and is independently associated with reduced QoL in women with SLE. Depression and anxiety are common among SLE patients, and the frequency is similar to that in patients with rheumatoid arthritis. A reciprocal longitudinal relationship between depression and illness intrusiveness was found in patients with SLE. Disease activity and damage are not associated with depression. The subjective experience, not the illness per se, causes depression.

October 2015
Lone Sølling Avnon MD, Alexander Smoliakov MD, Igor Sinelko MD and Mahmoud Abu-Shakra MD
August 2015
April 2015
Lior Zeller MD, Leonid Barski MD, Elena Shleyfer MD, Uri Netz MD, Vered Stavi MD and Mahmoud Abu-Shakra MD
October 2014
Orit Barrett MD, Ella Abramovich MD, Jacob Dreiher MD MPH, Victor Novack MD PhD and Mahmoud Abu-Shakra MD
September 2014
Mahmoud Abu-Shakra MD, Amit Mayer MD, Michael Friger PhD and Marco Harari MD

Background: Low back pain (LBP) is chronic disease without a curative therapy. Alternative and complementary therapies are widely used in the management of this condition.  

Objectives: To evaluate the efficacy of home application of Dead Sea mud compresses to the back of patients with chronic low back pain (LBP).

Methods: Forty-six consecutive Patients suffering from chronic LBP were recruited. All patients were followed at the Soroka University Rheumatic Diseases Unit.  The patients were randomized into two groups: group 1 was treated with mineral-rich mud compresses, and group 2 with mineral-depleted compresses. Mud compresses were applied five times a week for 3 consecutive weeks. The primary outcome was the patient’s assessment of the overall back pain severity. The score of the Ronald & Morris questionnaire served as a secondary outcome.

Results: Forty-four patients completed the therapy and the follow-up assessments: 32 were treated with real mudpacks and 12 used the mineral-depleted packs. A significant decrease in intensity of pain, as described by the patients, was observed only in the treatment group. In this group, clinical improvement was clearly seen at completion of therapy and was sustained a month later. Significant improvement in the scores of the Roland & Morris questionnaire was observed in both groups.

Conclusions: The data suggest that pain severity was reduced in patients treated with mineral-rich mud compresses compared with those treated with mineral-depleted compresses. Whether this modest effect is the result of a “true” mud effect or other causes cannot be determined in this study. 

November 2013
I. Strauss, T. Jonas-Kimchi, Z. Lidar MD, D. Buchbut, N. Shtraus, B. W. Corn and A. A. Kanner, T. Wolak, E. Aliev, B. Rogachev, Y. Baumfeld, C. Cafri,, M. Abu-Shakra and Victor Novack.
 Background: Contrast-induced nephropathy (CIN) is one of the major causes of new-onset renal failure in hospitalized patients. Although renin-angiotensin-aldosterone system (RAAS) blocking agents are widely used among patients requiring contrast studies, data on the effect of these agents on the development of CIN are sparse and inconsistent.  

Objectives: To evaluate in a randomized control trial whether uninterrupted administration of angiotensin II (AngII) blockade medications influence estimated glomerular filtration rate (eGFR) in patients undergoing non-emergent coronary angiography.

Methods: Patients receiving treatment with angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (ACE-I/ARB) were recruited consecutively. The enrolled subjects were randomized into three groups at a 1:1:1 ratio: group A (ACE/ARB stopped 24 hours prior to the procedure and restarted immediately after the procedure), group B (ACE/ARB stopped 24 hours prior to the procedure and restarted 24 hours after the procedure), and group C (ACE/ARB continued throughout the study period). Plasma creatinine was measured and eGFR was calculated according to the Cockroft-Gault equation before and 48 hours after the coronary angiography. The primary endpoint was a change in eGFR at 48 hours.

Results: Groups A, B and C comprised 30, 31 and 33 patients respectively. The mean age of the study population was 65 ± 12 years and 67% were males. Fifty percent of the subjects had diabetes mellitus. The primary endpoint analysis showed that at 48 hours after the procedure there was no difference in ΔeGFR between groups A and C (4.25 ± 12.19 vs. 4.65 ± 11.76, P = 0.90) and groups B and C (3.72 ± 17.42 vs. 4.65 ± 11.76, P = 0.82). In post-hoc analysis the patients were clustered according to the following groups: medical alternation (group A and B) versus control (group C) and to baseline eGFR ≥ 60 ml/min vs. eGFR < 60 ml/min. In patients with baseline eGFR < 60 ml/min the ΔeGFR (baseline eGFR-eGFR 48 hours post-angiography) was significantly different between the intervention vs. control group (median 5.61 vs. median -2.19, P = 0.03 respectively). While in patients with baseline eGFR ≥ 60 ml/min there was no significant difference in ΔeGFR between the intervention and control groups.

Conclusions: ACE-I and ARB can safely be used before and after coronary angiography in patients with eGFR ≥ 60 ml/min. 

February 2009
by Lone S. Avnon, MD, Fauaz Manzur, MD, Arkadi Bolotin, PhD, Dov Heimer, MD, Daniel Flusser, MD, Dan Buskila, MD, Shaul Sukenik, MD and Mahmoud Abu-Shakra, MD.

Background: A high incidence of abnormal pulmonary function tests has been reported in cross-sectional studies among patients with rheumatoid arthritis. Few patients have been enrolled in longitudinal studies.

Objectives: To perform PFT[1] in rheumatoid arthritic patients without pulmonary involvement and to identify variables related to changes in PFT over 5 years of follow-up.

Methods: Consecutive RA[2] patients underwent PFT according to American Thoracic Society recommendations. All surviving patients were advised to repeat the examination 5 years later.

Results: PFT was performed in 82 patients (21 men, 61 women). Their mean age was 55.7 (15.9) years and the mean RA duration was 11.1 (10) years. Five years later 15 patients (18.3%) had died. Among the 67 surviving patients, 38 (56.7%) agreed to participate in a follow-up study. The initial PFT revealed normal PFT in only 30 patients (36.6%); an obstructive ventilatory defect in 2 (2.4%), a small airway defect in 12 (17%), a restrictive ventilatory defect in 21 (25.6%), and reduced DLco in 17 (20.7%). Among the 38 patients participating in the 5 year follow-up study, 8 developed respiratory symptoms, one patient had a new obstructive ventilatory defect, one patient developed a restrictive ventilatory defect, and 5 patients had a newly developed small airway defect. The DLco had improved in 7 of the 8 patients who initially had reduced DLco, reaching normal values in 5 patients. Over the study period a new reduction in DLco was observed in 7 patients. Linear regression analyses failed to identify any patient or disease-specific characteristics that could predict a worsening in PFT. The absolute yearly decline in forced expiratory volume in 1 sec among our RA patients was 47 ml/year, a decline similar to that seen among current smokers.

Conclusions: Serial PFT among patients with RA is indicated and allows for earlier identification of various ventilatory defects. Small airways disturbance was a common finding among our RA patients.






[1] PFT = pulmonary function testing



[2] RA = rheumatoid arthritis


February 2001
Shaul Sukenik, MD, Ron Baradin, MD, Shlomi Codish, MD, Lily Neumann, PhD, Daniel Flusser, MD, Mahmoud Abu-Shakra, MD and Dan Buskila, MD

Background: Balneotherapy has been successfully used to treat various rheumatic diseases, but has only recently been evaluated for the treatment of fibromyalgia. Since no effective treatment exists for this common rheumatic disease, comple­mentary methods of treatment have been attempted.

Objectives:To assess the effectiveness of batneotherapy at the Dead Sea area in the treatment of patients suffering from both fibromyalgia and psoriatic arthritis.

Methods: Twenty-eight patients with psoriatic arthritis and fibromyalgia were treated with various modalities of bat­neotherapy at the Dead Sea area. Clinical indices assessed were duration of morning stiffness, number of active joints, a point count of 18 fibrositic tender points, and determination of the threshold of tenderness in nine fibrositic and in four control points using a dolorimeter.

Results: The number of active joints was reduced from 18.4+10.9 to 9+8.2 (P< 0.001). The number of tender points was reduced from 12.6+2 to 7.1±5 in men (P<0.003) and from 13.1+2 to 7.5+3.7 in women (P<0.001). A significant improvement was found in dolorimetric threshold readings after the treatment period in women (P< 0.001). No correlation was observed between the reduction in the number of active joints and the reduction in the number of tender points in the same patients (r= 0.2).

Conclusions: Balneotherapy at the Dead Sea area appears to produce a statistically significant substantial improvement in the number of active joints and tender points in both male and female patients with fibromyalgia and psoriatic arthritis. Further research is needed to elucidate the distinction between the benefits of staying at the Dead Sea area without balneotherapy and the effects of balneotherapy in the study population.

August 2000
Shlomi Codish, MD, Mahmoud Abu-Shakra, MD, Roman Depsames, MD, Neta Sion-Vardy, MD, Dan Benharroch, MD and Shaul Sukenik, MD
October 1999
Shaul Sukenik MD, Daniel Flusser MD, Shlomi Codish MD and Mahmoud Abu-Shakra MD
 Background: Balneotherapy at the Dead Sea area has been applied in various inflammatory rheumatic diseases such as rheumatoid arthritis and psoriatic arthritis. The efficacy of balneotherapy at the Dead Sea area for the treatment of degenerative rheumatic diseases has not yet been formally evaluated.

Objective: To evaluate the efficacy of balneotherapy at the Dead Sea area in patients suffering from osteoarthritis of the knees.

Methods: Forty patients were randomly allocated into four groups of 10 patients. Group I was treated by bathing in a sulphur pool, group 2 by bathing in the Dead Sea, group 3 by a combination of sulphur pool and bathing in the Dead Sea, and group 4 served as the control group receiving no balneotherapy. The duration of balneotherapy was 2 weeks.

Results: Significant improvement as measured by the Lequesne index of severity of osteoarthritis was observed in all three treatment groups, but not in the control group. This improvement lasted up to 3 months of follow-up in patients in all three treatment groups.

Conclusion: Balneotherapy at the Dead Sea area has a beneficial effect on patients with osteoarthritis of the knees, an effect that lasts at least 3 months.

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