Efficacy of sulfasalazine in patients with inflammatory back pain due to undifferentiated spondyloarthritis and early ankylosing spondylitis: a multicentre randomised controlled trial.

OBJECTIVES: To assess the effect of sulfasalazine (SSZ) on inflammatory back pain (IBP) due to active undifferentiated spondyloarthritis (uSpA) or ankylosing spondylitis in patients with symptom duration <5 years. METHODS: Patients with IBP and a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >3 from 12 centres were randomly assigned to 24 weeks' treatment with SSZ 2 g/day or placebo. The primary outcome variable was the change in BASDAI over 6 months. Secondary outcomes included measures of spinal pain, physical function and inflammation. RESULTS: 230 patients (50% men, age range 18-64 years, 67% human leucocyte antigen B27 positive) were treated with either SSZ 2x1 g/day or placebo for 6 months. Enthesitis was found in 50%, and peripheral arthritis in 47% of the patients. The mean (SD) BASDAI dropped markedly in both groups: by 3.7 (2.7) and 3.8 (2.4), respectively, as did most secondary outcome measures. No noticeable difference in treatment was observed between groups. Patients with IBP and no peripheral arthritis had significantly (p = 0.03) more benefit with SSZ (BASDAI 5.1 (1.3) to 2.8 (2.3)) than with placebo (5.2 (1.6) to 3.8 (2.4)). Spinal pain (p = 0.03) and morning stiffness (p = 0.05) improved with SSZ in these patients, but other secondary outcomes were not markedly different. CONCLUSION: SSZ was no better than placebo for the treatment of the signs and symptoms of uSpA; however, SSZ was more effective than placebo in the subgroup of patients with IBP and no peripheral arthritis.

Efficacy and safety of eltenac gel in the treatment of knee osteoarthritis.

OBJECTIVE: A double-blind, placebo-controlled dose-finding study was performed in 237 patients with predominantly unilateral knee osteoarthritis (OA) evaluating efficacy and safety of a new topical NSAID. DESIGN: The patients applied 3 g tid eltenac gel 0.1%, 0.3%, 1% or placebo gel over a period of 4 weeks. The patients were supplied with paracetamol tablets as an escape analgesic. Primary efficacy end-point was mean global pain in the week preceding the examinatio ns, evaluated on a visual analog scale (VAS). Secondary criteria were Lequesne's score ISK, Jezek score, muscle strength and dolorimeter measurements, walking time, clinical examination results of the knee joint and patient's and investigator's overall efficacy estimates. RESULTS: The graphical depiction of VAS and ISK suggested a dose-related efficacy, but the pre-planned statistical analysis did not show significant differences between treatments. In the patient subgroup with a higher degree of baseline severity of knee OA the ISK showed significant and relevant advantages of eltenac gel 1% to placebo at different examination times. Two patients each of the eltenac gel 1% group and the placebo group showed local intolerance reactions which subsided spontaneously. CONCLUSION: This study did not provide confirmatory proof of an efficacy of topical eltenac in patients with knee OA. Methodological pitfalls and possible responder subgroups are described. Despite the difficulties, dose-finding studies seem to be feasible even with topical NSAIDs.

Repeated cyclosporine therapy of peripheral arthritis associated with ankylosing spondylitis.

BACKGROUND: A case history of a patient with ankylosing spondylitis and peripheral arthritis unresponsive to the conventional drug therapy, but successfully controlled by the use of cyclosporin. MATERIAL AND METHODS: In a 68 years old female patient with a 36 years history of typical ankylosing spondylitis a peripheral polyarthritis (hands, feet, wrists, and knees) developed. The patient did not suffer any other disease known to cause secondary spondylitis (psoriasis, inflammatory, bowel, disease). After the unsuccessful use of non-steroidal antiinflammatory drugs a combination therapy with cyclosporin (4 mg/kg/day) and azapropazone (300 mg t.i.d.) was introduced. RESULTS: Clinical improvement was achieved after 6 months of combined therapy, the polyarthritis completely resolved after one year. Therefore cyclosporin was discontinued. After one year the polyarthritis reappeared therefore the cyclosporin therapy was reinstituted with success. CONCLUSION: Cyclosporin has proved consistently effective in our case to control the peripheral arthritis associated with ankylosing spondylitis.

[Various clinical patterns of relapsing polychondritis in six cases]. / Polychondritis recidivans sokszínú klinikai megjelenése hat eset kapcsán.

Relapsing polychondritis is a relatively rare disease characterized by episodic inflammation and progressive destruction of cartilage involving ears, nasal and laryngotracheal cartilage, cardiovascular system and the eyes. The increasing awareness of its clinically distinct has resulted in recognition of at least 550 reported cases. Six cases are reported to demonstrate the wide variety of clinical pattern. The most common features of the disease are auricular and nasal cartilage inflammation and nondeforming arthritis. Ocular symptoms and vasculitis is relatively rare. Two cases of relapsing polychondritis with laryngotracheobronchial manifestations illustrate the severe clinical features of the disease. Relapsing polychondritis may associate with diverse forms of connective tissue disease, such as rheumatoid arthritis. It seems interesting to note the onset in childhood. Treatment has been primarily symptomatic. In situations of mild symptoms, initial treatment is with nonsteroidal antiinflammatory drugs. For cases with serious manifestation, corticosteroids and immunosuppressants are indicated.

A comparison of the efficacy and safety of leflunomide and methotrexate for the treatment of rheumatoid arthritis.

OBJECTIVE: To compare the clinical efficacy and safety of leflunomide and methotrexate for the treatment of rheumatoid arthritis (RA). METHODS: In this multicentre, double-blind trial, 999 subjects with active RA were randomized to leflunomide (n = 501; loading dose 100 mg/day for 3 days, maintenance dose 20 mg/day) or methotrexate (n = 498; 10-15 mg/week) for 52 weeks. After 1 yr the subjects could choose to stay for a second year of double-blind treatment. The primary end-points were tender and swollen joint counts and overall physician and patient assessments. Analyses were of the intent-to-treat group. RESULTS: After 1 yr, the mean changes in the leflunomide and methotrexate groups, respectively, were -8.3 and -9.7 for tender joint count; -6.8 and -9.0 for swollen joint count; -0.9 and -1.2 for physician global assessment; -0.9 and -1.2 for patient global assessment; -14.4 and -28.2 for erythrocyte sedimentation rate. Improvements seen with methotrexate were significantly greater than those with leflunomide. No further improvement occurred after the second year of treatment and the distinction between the two treatments in terms of tender joint count and patient global assessment was lost. During the first year of treatment, a small and equivalent degree of radiographically assessed disease progression was seen with both drugs. After 2 yr, disease progression was significantly less with methotrexate. The most common treatment-related adverse events in both groups were diarrhoea, nausea, alopecia, rash, headache, and elevated plasma liver enzyme levels. Over 2 yr, 21 subjects receiving methotrexate were withdrawn due to elevated plasma liver enzymes vs eight subjects taking leflunomide. Two drug-related deaths from pulmonary causes were recorded with methotrexate vs no drug-related deaths among the subjects receiving leflunomide. CONCLUSIONS: Both leflunomide and methotrexate are efficacious for prolonged treatment of RA. At the doses used, some clinical benefit of methotrexate over leflunomide was observed in the first year of treatment. This benefit must be weighed against the potential toxicity of this drug when used without folate supplementation.

Nabumetone induces less gastrointestinal mucosal changes than diclofenac retard.

The aim of the study was to compare the efficacy and the effects on the mucosa of the gastrointestinal tract (GIT) of nabumetone and diclofenac retard in patients with osteoarthritis (OA). An open, multicentre, randomised, comparative, endoscopy-blind parallel group study included 201 patients with nabumetone and 193 patients with diclofenac retard suffering from moderate to severe OA of the knee or hip joint. Twelve clinical efficacy variables were assessed and a portion of the population underwent gastroduodenoscopy. All patients exhibited significant improvement in pain severity and pain relief (p < 0.001 and p < 0.0001, respectively) but there were no differences between the groups for all the efficacy variables. Eleven per cent of patients on nabumetone and 19% on diclofenac experienced GIT side-effects. Sixty-nine patients with nabumetone and 61 with diclofenac underwent gastroduodenoscopy. The differences in the mucosal grade for the oesophagus, stomach and duodenum at baseline were not significant. In the oesophagus there were significantly less changes after treatment with nabumetone (p = 0.007) than with diclofenac; there were similar findings in the stomach (p < 0.001) but the difference in the duodenum was not significant. This study indicates that nabumetone and diclofenac retard have similar efficacy in the treatment of OA, but nabumetone has significantly fewer GIT side-effects.

[Selective inhibition of cyclooxygense (COX-2)]. / A szelektív ciklooxigenáz (COX-2)-gátlás.

The author gives a brood outline of the circumstances of the inhibition of cyclooxygenase (COX) giving special emphasis to the different role of the two isoforms COX-1 and COX-2. More selective COX-2 inhibition can be have required practical effect in reducing of inflammation with less side effects. To set a correct determination of COX-2/COX-1 quotiens is difficult because of numerous methodical problems. We have to rely on the clinical experiences gained through long usage of some drugs.

[Routine examinations in the densitometry department]. / Studien aus dem Alltag der densitometrischen Abteilung.

The authors describe observations on the basis of the high number of patients at their osteodensitometry clinic. They found that in ankylosing spondylitis vertebral osteodensity would not be practical to be taken into account for estimating osteopenia. They suggest the "slicing" method of the 4th lumbar vertebra, taking into consideration the middle slice only. The second part of their study proved that daughters of their patients, suffering from osteoporosis with fractured vertebra, had significantly lower osteodensity as compared with the age and menstrual cycle-matched controls.

Epileptogenic activity of folic acid after drug induces SLE (folic acid and epilepsy)

OBJECTIVE: To study the effect of folic acid-containing multivitamin supplementation in epileptic women before and during pregnancy in order to determine the rate of structural birth defects and epilepsy-related side effects. STUDY DESIGN: First a randomised trial, later periconception care including in total 12225 females. RESULTS: Of 60 epileptic women with periconceptional folic acid (0.8 mg)-containing multivitamin supplementation, no one developed epilepsy-related side effects during the periconception period. One epileptic woman delivered a newborn with cleft lip and palate. Another patient exhibited with a cluster of seizures after the periconception period using another multivitamin. This 22-year-old epileptic woman was treated continuously by carbamazepine and a folic acid (1 mg)-containing multivitamin from the 20th week of gestation. She developed status epilepticus and later symptoms of systemic lupus erythematodes. Her pregnancy ended with stillbirth. CONCLUSIONS: The epileptic pregnant patient's autoimmune disease (probably drug-induced lupus) could damage the blood-brain barrier, therefore the therapeutic dose (> or =1 mg) of folic acid triggered a cluster of seizures. Physiological dose (<1 mg) of folic acid both in healthy and 60 epileptic women, all without any autoimmune disease, did not increase the risk for epileptic seizures.

[Determination of diminished bone mineral density in ankylosing spondylitis]. / Csökkent csont ásványianyag-tartalom igazolása spondylitis ankylopoeticában.

Bone mineral density was determined by DEXA method on the lumbal spine and on the femoral neck, on 44 patients suffering from ankylosing spondylitis. It was established that the osteopenie (low bone mineral density) was covered by the syndesmophytes. The comparative measurement showed a lower bone mineral density for patients, who don't have syndesmophytes on the L II-IV. vertebraes.

Dermatoglyphics and ankylosing spondylitis.

Dermatoglyphics "the epidermal ridge configurations of the fingers, toes, palms and soles", not only help identify individuals, but have been proved to give important information about some genetic disorders. This study was aimed at finding a possible correlation between the dermatoglyphic differences in patients with ankylosing spondylitis (AS) and the HLA B27 antigen. The dermatoglyphic patterns of AS patients were compared with the data of control subjects. Significant dermatoglyphic abnormalities were found, but there proved to be no connection between the HLA B27 antigens. We therefore conclude that HLA B27 does not contribute to the development of dermatoglyphic abnormalities. It seems, however, that our findings provide some new nosographic information to the natural picture of AS.

[Effect of spinal exercises on spinal parameters in Scheuermann disease]. / Gerinctorna hatása Scheuermann-betegek gerinc-paramétereire.

Changes in the parameters of the spine (grade of kyphosis, total mobility of dorsolumbal spine, lumbal Schober's sign, finger-ground distance) within one year were studied in 103 Scheuermann-patients. In patients doing regular exercises the kyphosis did not increase and their finger-ground distance improved significantly; whilst in patients not doing regular exercises the kyphosis increased slightly though significantly, and their finger-ground distance did not improve. These result prove the beneficial effect of regular exercises.

[Yersinia-induced arthritis in patients with spondylitis ankylopoietica of 20-year duration]. / Yersinia reaktív arthritis elöfordulása 20 éve spondylitis ankylopoeticában szenvedö betegen.

The case of a 46 years old woman with spondylitis ankylopoetica is reported. Following diarrhoea a severe, asymmetric oligoarthritis developed with positive Yersinia enterocolitica serology. The acute oligoarthritis repressed after 2 month.

Juvenile psoriatic arthritis.

Among 664 juvenile chronic arthritis patients cared for in the Outpatient Clinic of the Pediatric Rheumatology Unit of the National Institute of Rheumatology and Physiotherapy 11 were found with juvenile psoriatic arthritis, and their data regarding skin, joint, ophthalmological, laboratory and radiological manifestations were analysed. These patients were categorised according to the four subgroups suggested by Truckenbrodt et al. Considering that the occurrence of the disease is rare, the small number of patients investigated in this study can provide additional data to the study of Truckenbrodt. The higher number of patients with JPA thus studied can give more information for a multicentric evaluation.

A simple method for measuring lateral flexion of the dorsolumbar spine.

A simple method for measurement of spinal dorsolumbar lateral flexion is described. Measurements performed on 200 healthy 19-year-old men showed that normal lateral flexion was about 10% of body height. The method which requires only a measuring tape correlates well with that recorded by the more sophisticated inclinometer.

Milurit's place in therapy.

After a brief review of the history of allopurinol therapy the mechanism of action, interactions with other drugs, side-effects, indications and contra-indications of Milurit (100 mg allopurinol per tab, EGIS Pharmaceuticals, Budapest) in adults and children, and the dosage of the drug have been discussed. It has been emphasized that allopurinol is an effective but not the sole means in the treatment of clinical processes accompanied by hyperuricaemia. The adequate choice of a drug in a given indication field not only improves the therapeutic results but prevents the development of one part of the side-effects such as among others the severe allopurinol hypersensitivity syndrome which often has a lethal outcome.