Troels Mørk Hansen

Mortality and Causes of Death of 513 Danish Patients with Systemic Lupus Erythematosus

A multicentre cohort of 513 clinic attenders with systemic lupus erythematosus (SLE) was retrospectively identified, representing 4185 patient-years of follow-up. Expected numbers of death were calculated by means of age- and sex-specific mortality rates of the general Danish population. The observed number of deaths was 122. The survival rates were 97%, 91%, 76%, 64% and 53% after 1, 5, 10, 15, and 20 years respectively. The overall mortality rate was 2.9% per year (95% CI 2.4-3.5), and the standardized mortality rate (SMR) was 4.6 (95% CI 3.8-5.5). The causes of death included active SLE (n = 19), end stage organ failure due to SLE (n = 16), infections (n = 25), malignancy (n = 9), cardiovascular disease (n = 32), and other causes (n = 21). SLE was directly related to one third of the excess mortality. In conclusion, SLE patients in the present cohort had a 4.6-fold increased mortality compared with the general population and half of the deaths were caused by SLE manifestations or infections, especially in young patients during the early period of the disease.

Longterm Physical Training in Rheumatoid Arthritis. A Randomized Trial with Different Training Programs and Blinded Observers

The objective was to study the long-term effect (2 years) of different training programs in patients with rheumatoid arthritis. The method was a randomized trial with 75 patients participating. The measured variables included morning stiffness, a pain score, number of swollen joints, a health assessment score, a functional score, ESR, Hb, the cost of medicine, and progression using X-rays of hands and feet. The results showed no effect of training on the disease activity or on the progression of the disease. The conclusion is that although most patients are in favour of training, the present study does not support that training lessons per se affect the disease activity or the progression of the disease.

A randomised trial of differentiated prednisolone treatment in active rheumatoid arthritis. Clinical benefits and skeletal side effects.

OBJECTIVES To study benefits and skeletal side effects of carefully monitored prednisolone treatment in patients with active rheumatoid arthritis. METHODS One hundred and two patients with active rheumatoid arthritis were randomly allocated to treatment with disease modifying anti-inflammatory drug (DMARD) alone or DMARD and prednisolone in a one year follow up study. Prednisolone was given in a dose regimen adapted to the disease activity of the individual patient. The mean dose was 6 mg and the mean cumulated dose was 2160 mg. Patients were followed up with disease activity parameters, radiograph of the hands (Larsen score), and bone mineral density (BMD) of the lumbar spine, distal forearm and hand. At one year 26 patients had withdrawn from the investigation leaving 76 patients for evaluation. RESULTS The results showed that disease activity in the prednisolone treated group was reduced within two weeks. In the DMARD alone group disease activity was gradually reduced over months. At six months there was no difference between the groups as evaluated by an improvement score using a number of ACR criteria. Prednisolone in the present set up was not able to protect significantly against radiological disease progression, although there was a trend towards less progression in Larsen score in the prednisolone group, a matter that was further underlined in an intention to treat analysis. BMD data revealed a significant reduction in spinal BMD in the prednisolone group, whereas prednisolone seemed to have a protective effect against bone loss in the hand and distal forearm. CONCLUSIONS This study does not allow any firm conclusions for or against the treatment of rheumatoid arthritis with prednisolone. The data suggest that the beneficial effects of prednisolone are not as clear cut in established rheumatoid arthritis as in early disease. Furthermore the data indicate that treatment in the chosen relatively low dose does not provide sufficient control of disease. On the other hand the spinal bone loss observed in the prednisolone group does invite considerations about using higher doses.

Serum ferritin and the assessment of iron deficiency in rheumatoid arthritis

In order to evaluate the diagnostic and pathogenetic importance of s-ferritin and p-lactoferrin in the anemia of rheumatoid arthritis (RA), 38 patients were examined. Twenty-one out of 38 randomly selected anemic patients with classical or definite RA had iron deficiency, as estimated from the iron content in stained bone marrow aspiration. S-ferritin concentrations below 60 micrograms per litre had sensitivity and a specificity for iron deficiency of 86% and 88%, respectively, which was much better than such commonly used variables as s-iron, p-transferrin, MCV, and MCHC. Although this cut-off level is higher than in patients without inflammatory disease, s-ferritin was not correlated to disease activity. In 7 out of 8 patients, the s-ferritin level rose during iron therapy. P-lactoferrin values were within the normal range and did not vary with the anemia or with disease activity. Thus p-lactoferrin appears to be of no pathogenetic importance in the anemia of RA.

Adaptation into Danish of the Stanford Health Assessment Questionnaire (HAQ) and the Rheumatoid Arthritis Quality of Life Scale (RAQoL).

OBJECTIVES The study was designed to adapt the Stanford Health Assessment Questionnaire (HAQ) and the Rheumatoid Arthritis Quality of Life Questionnaire (RAQoL) for use in Denmark. METHOD The instruments were translated into Danish and then field-tested with 10 RA patients for relevance, and face and content validity. Reliability and validity were assessed by administering the new measures and a comparator instrument (the Danish Nottingham Health Profile) to 80 RA patients on two occasions. RESULTS Patients found both measures acceptable and easy to complete. They had good test-retest reliability (>0.90) and internal consistency and were both able to discriminate between groups with different levels of functional status and self-perceived severity. When compared with the NHP sections, both measures showed expected convergence and divergence. CONCLUSION Given the excellent psychometric properties of the Danish versions of the RAQoL and HAQ, both are recommended for inclusion in clinical trials and studies.Objectives: The study was designed to adapt the Stanford Health Assessment Questionnaire (HAQ) and the Rheumatoid Arthritis Quality of Life Questionnaire (RAQoL) for use in Denmark. Method: The instruments were translated into Danish and then field-tested with 10 RA patients for relevance, and face and content validity. Reliability and validity were assessed by administering the new measures and a comparator instrument (the Danish Nottingham Health Profile) to 80 RA patients on two occasions. Results: Patients found both measures acceptable and easy to complete. They had good test-retest reliability (>0.90) and internal consistency and were both able to discriminate between groups with different levels of functional status and self-perceived severity. When compared with the NHP sections, both measures showed expected convergence and divergence. Conclusion: Given the excellent psychometric properties of the Danish versions of the RAQoL and HAQ, both are recommended for inclusion in clinical trials and studies.

Treatment of Rheumatoid Arthritis with Prostaglandin E1, Precursors CIS-Linoleic Acid and γ-Linolenic Acid

20 patients with active rheumatoid arthritis were treated for 12 weeks with the prostaglandin E, precursors cis-linoleic acid and γ-linolenic acid in the form of primrose evening oil (Efamol®) and the co-factors zinc, ascorbic acid, niacin, and pyridoxin (Efavit®). There was a slight fall in skin reactivity to UV light during the treatment, but no effect on plasma or urine concentrations of PGE1, cAMP or cGMP. There was no effect of the treatment on ESR, P-fibrinogen, number of tender joints, number of swollen joints, the duration of morning stiffness, or on the patients estimation of pain.

Prognostic value of renal biopsy and clinical variables in patients with lupus nephritis and normal serum creatinine.

OBJECTIVE To evaluate factors with possible influence on the renal outcome in patients with lupus nephritis but without chronic renal insufficiency (CRI). METHODS Renal biopsies from 94 patients were re-assessed with regard to WHO class, activity, chronicity and tubulointerstitial indices without knowledge of clinical features. The outcome parameters were CRI defined as irreversibly increased serum creatinine and renal end stage disease. RESULTS The risk ratios (RR) of developing CRI were 2.6 for active urinary sediment, 3.1 for hyaline thrombi and 7.3 for glomerular leukocyte exudation. The RR of renal end stage disease was 5.0 when the duration of renal disease exceeded one year at the time of biopsy and 4.3 when biopsy disclosed a class IV lesion. Glomerular sclerosis was also associated to renal end stage disease. CONCLUSION Early renal biopsy and the abovementioned signs of active renal disease carry prognostic information that may have significant therapeutic implications.

Clinical Examination of Pelvic Insufficiency during Pregnancy: An evaluation of the interobserver variation, the relation between clinical signs and pain and the relation between clinical signs and physical disability

The purpose of this study was to answer the following questions: Do clinical signs in pregnant women with pelvic pain differ from signs in those without pelvic pain? Is there variation between the test signs found by four observers? Are the clinical signs correlated to pain and physical disability? Twenty pregnant women with pelvic pain and 20 pregnant women without pelvic pain were participating. Each woman reported her own pain sensation and physical disability and each woman was examined by 4 physiotherapists independently. Sixty-one clinical tests were applied. Only 8 tests showed predominantly positive signs in the pain group. These tests showed agreement between different observers judged by a kappa coefficient > 0.40. The number of positive clinical signs was well correlated to the reported pain and physical disability. The value of an extensive examination of posture, muscles and joints on pregnant women with pelvic pain is dubious.

A Double-blind Comparative Study of Hydroxychloroquine and Dapsone, Alone and in Combination, in Rheumatoid Arthritis

Eighty patients with active rheumatoid arthritis (RA) entered a double-blind randomized study of 24 weeks duration, to compare the efficacy and toxicity of hydroxychloroquine, dapsone, and a combination of both drugs in treatment of RA. Evaluation of changes in clinical, laboratory and radiologic variables was based on 63 patients completing the trial. There was no clear difference between the three therapy groups in most inflammatory variables after 24 weeks. However, only patients receiving the combination therapy improved significantly in all clinical and laboratory variables. Nine patients in the combination group and four in each single drug group discontinued during the trial, mainly because of toxicity. Four patients taking the combination therapy withdrew because of hemolytic anemia, and none in the dapsone group. These findings suggest that hydroxychloroquine in combination with dapsone is somewhat more effective and less tolerated than single drug treatments.

Clinical Synovitis and Radiological Lesions in Rheumatoid Arthritis: A Prospective Study of 25 Patients during Treatment with Remission-inducing Drugs

The joints of hands and feet of 25 patients (1150 joints) with rheumatoid arthritis were compared, joint by joint, clinically and radiologically, over 2 years of treatment with remission-inducing drugs. Joints with clinical signs of synovitis decreased from 47% to 17% (p less than 0.001), while the number of joints with radiological lesions increased from 23% to 27% (p less than 0.01). Definite radiological progression of bone lesions was seen in 7% of the joints. Joints with clinical synovitis had a higher risk of progressive bone damage than joints without clinical synovitis (p less than 0.001) and joints in which the clinical signs of synovitis persisted during the study had a higher risk of progressing bone lesions than joints in which the clinical synovitis subsided (p less than 0.001). Progressive bone damage was seen more often in swollen joints than in tender joints without swelling or joints without clinical signs of synovitis (p less than 0.001), the difference in radiological progression between the latter two groups being non-significant. Twenty-one per cent of the joints with progressive bone lesions had no clinical signs of synovitis during the period.