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PubMed2006

Outcomes in ankylosing spondylitis: what makes the assessment of treatment effects in ankylosing spondylitis different?

There are four major challenges in the assessment of outcomes in patients with ankylosing spondylitis (AS) that are particularly relevant to the evaluation of new therapies. Firstly, measures of symptoms and impairment in AS are not specific for inflammatory processes, they also capture mechanical symptoms and fixed limitations. The non-specific nature of these measures may cause them to be less responsive and therefore less useful in determining treatment efficacy. Secondly, acute phase reactants have limited value as measures of AS activity and other surrogate markers have not yet been established. Thirdly, the assessment of the disease modifying potential of new therapies is hampered by the slow rate of spinal fusion. Fourthly, work disability has not be studied as an endpoint in clinical trials in AS, despite the fact that work disability is an important outcome in patients with AS. Research into ways to overcome these challenges in outcome measurement will help identify useful therapies and define the range of outcomes that they influence.

Biomarkers↗
PubMed1978

Ankylosing spondylitis and inflammatory bowel disease. I. Prevalence of inflammatory bowel disease in patients suffering from ankylosing spondylitis.

To establish the prevalence of inflammatory bowel disease in ankylosing spondylitis (AS), 79 AS patients underwent detailed medical screening, including sigmoidoscopic and roentgenological examination, 48 had gastrointestinal symptoms and the others did not. In 3 patients a diagnosis of Crohn's disease was made which was previously established. In all other patients inflammatory bowel disease could be excluded. The prevalence of inflammatory bowel disease in this series of patients with AS therefore was 3.8%.

Enteritis↗
PubMed1978

Ankylosing spondylitis and inflammatory bowel disease. III. Clinical characteristics and results of histocompatibility typing (HLA B27) in 50 patients with both ankylosing spondylitis and inflammatory bowel disease.

A study was made, in co-operation with several gastroenterology and rheumatology centres, of the clinical and genetic characteristics (HLA B27) of 50 patients suffering from both inflammatory bowel disease (38 Crohn's disease (CD), 12 ulcerated colitis (UC)) and ankylosing spondylitis (AS), the latter diagnosis being established according to the New York criteria. 20 CD (52.6%) and 8 UC (66.7%) patients were HLA B27 positive. The presence of HLA B27 was studied in relation to clinical parameters, such as first occurrence of symptoms of AS or inflammatory bowel disease (IBD), a history of peripheral arthritis, iridocyclitis, and a positive history of AS or IBD. Our patients were found to have heterogeneous clinical features: on one side of the spectrum a group of cases was distingiushed with the typical characteristics of idiopathic AS, often being HLA B27 positive. On the other side a smaller group of HLA B27 negative patients was observed, with severe intestinal inflammatory pathology, lacking most of the typical clinical features of idiopathic AS ('secondary' form of AS). Finally, between these two extremes a group of patients was found with less pronounced clinical or genetic characteristics. These different clinical and histocompatibility patterns suggest a mixed aetiopathogenesis of AS in IBD patients. Such a 'syndrome' of AS might harbour both idiopathic AS and forms of AS 'secondary' to the intestinal inflammatory pathology.

Adult↗
PubMed1985

Spinal ankylosing spondylitis: a variant form of ankylosing spondylitis or a distinct disease entity?

In a population survey of ankylosing spondylitis (AS) seven subjects, six males and one female, had x-ray changes in the lumbar spine typical of AS but without concomitant roentgenological sacroiliitis. The overall prevalence of such cases in the population studied was 0.37%. Four out of these seven subjects carried the tissue antigen HLA-B27 (57%). The clinical and roentgenological features of these subjects are described and it is suggested that the x-ray findings represent a mild and variant form of primary or definite AS.

Adult↗
PubMed1992

Ankylosing spondylitis and HLA-B27: restriction fragment length polymorphism and sequencing of an HLA-B27 allele from a patient with ankylosing spondylitis.

Two groups of patients with ankylosing spondylitis (AS) from England and Poland were examined for restriction fragment length polymorphisms (RFLPs) associated with the disease. No preferential association was found between the 9.2 kb PvuII fragment in HLA-B27 positive patients with AS compared with HLA-B27 healthy subjects as had been previously reported. In the English group, however, a 14 kb PvuII fragment was more common in HLA-B27 positive subjects with AS than in normal controls. Also 4.6 and 3.7 kb PvuII fragments were more prevalent in subjects without AS than in the group with AS, but these results were confined to the English group. Furthermore, the sequence of an HLA-B*2705 gene isolated from a patient with AS was examined, and no significant differences were found compared with the sequence isolated from a healthy subject. There do not seem to be significant genetic differences in the coding or in the regulatory region in HLA-B27 alleles, in subjects with or without AS.

Alleles↗
PubMed2002

Building consensus on nomenclature and disease classification for ankylosing spondylitis: results and discussion of a questionnaire prepared for the International Workshop on New Treatment Strategies in Ankylosing Spondylitis, Berlin, Germany, 18-19 January 2002.

BACKGROUND: There is currently no universal consensus on nomenclature for spondyloarthropathy (SpA), or on activity and severity criteria for ankylosing spondylitis (AS). METHOD: Points of agreement and majority opinions among 28 international experts in the field were identified by questionnaire. Agreement was defined as >80% concurrence, clear majority as >60% concurrence, and a majority or trend as >50% concurrence. RESULTS: Respondents agreed on the need for one term that reflects the inflammatory nature of the disease, but no agreement was reached on a specific term. Agreement included subdivision of patients with SpA into AS, psoriatic arthritis, inflammatory bowel disease associated arthritis, and undifferentiated spondyloarthritis/spondyloarthropathy. A majority of experts defined active disease as fulfilling classification criteria for AS and/or a SpA, and disease activity measured by a Bath AS Disease Activity Index (BASDAI) score >4 determined by two patient visits during a two month period, but no maximum radiographic score. The majority of participants considered failure of treatment response to non-steroidal anti-inflammatory drugs (NSAIDs) alone to be a prerequisite for active/severe AS, and 15/28 (54%) thought that NSAID treatment failure should be defined as lack of response to two or more NSAIDs. CONCLUSIONS: Respondents agreed that a two to five year study is the ethical method to demonstrate effects of anti-tumour necrosis factor alpha (TNFalpha) therapy on radiographic progression of AS, and that inclusion criteria should include a certain level of disease activity (measured by BASDAI) and failure of certain treatments. After the efficacy of anti-TNFalpha therapy in AS and psoriatic arthritis is proved, respondents agreed that more studies will be needed to show efficacy for other SpA subsets.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed2002

Birth order and ankylosing spondylitis: no increased risk of developing ankylosing spondylitis among first-born children.

OBJECTIVE: In the HLA-B27 transgenic mouse model the first litters have been shown to have a higher percentage of diseased offspring than later litters. First-born children (n = 162) have also been shown to have a higher risk of ankylosing spondylitis (AS) than later-born children. We examined this effect of birth order using similar methods but larger numbers. METHODS: Patients from the Bath AS database (n = 4517; M:F = 2.5:1) were examined according to position of birth within the family. Chi-squared analysis was used to examine if AS was more prevalent among first-born than later-born children. RESULTS: The first-born child was not significantly more likely to have AS than later-born children (p = 0.295). [Observed compared to expected: 1607 (36%) compared to 1641.13 (36%) for first-born children and 2910 (64%) compared to 2876.3 (64%) for later-born children, respectively.] There was no biological gradient (i.e., inverse correlation between birth order and disease risk). CONCLUSION: There was no statistically significant effect of birth order based on our data. Findings suggesting a birth order effect may be skewed, as it is possible that those parents who do have AS will be less likely to have a large family and yet it is their offspring who will be at greatest risk of developing disease. This will affect the data, as those children born into a large family (i.e., high birth order children) will be at a lower risk of AS than any child born into a small but family-history-positive unit.

Adult↗
PubMed1980

The role of Klebsiella in the pathogenesis of ankylosing spondylitis. II Evidence for a specific B27-associated marker on the lymphocytes of patients with ankylosing spondylitis.

Although the strong association of HLA-B27 with ankylosing spondylitis (AS) is well documented, the significance of this association is largely unknown. It has recently been reported that Klebsiella pneumoniae was present in the faeces of patients with AS more frequently than in healthy individuals, and that there appeared to be some cross-reactivity between HLA-B27 and Klebsiella. We have therefore attempted to gain an insight into the possible role of Klebsiella in the pathogenesis of AS. The results presented here indicate that HLA-B27 positive individuals with AS have a significantly lower in vitro lymphocyte responsiveness to Klebsiella antigens, as compared with B27 positive and B27 negative healthy controls. By contrast, B27 positive patients with AS as well as B27 positive and negative controls respond equally well to phytohaemagglutinin, Staphylococcus, Streptococcus, Yersinia and Shigella. To investigate a possible cross-reactivity between Klebsiella and HLA-B27, antisera were raised in rabbits against various isolates of Klebsiella. An antiserum to one isolate (427) of Klebsiella lysed the lymphocytes of B27 positive AS patients but not of B27 positive or B27 negative controls. These observations strongly suggest that some Klebsiella antigens cross-react with a gene product closely associated with HLA-B27 or possibly with a modified B27 antigen in patients with AS.

Animals↗
PubMed1996

Aceclofenac is as safe and effective as tenoxicam in the treatment of ankylosing spondylitis: a 3 month multicenter comparative trial. Spanish Study Group on Aceclofenac in Ankylosing Spondylitis.

OBJECTIVE: To compare in a 3 month, multicenter, double blind, parallel study the efficacy and safety of a nonsteroidal antiinflammatory drug, aceclofenac, 100 mg bid orally, with that of tenoxicam, 20 mg orally at bedtime, in the treatment of adult patients with active ankylosing spondylitis (AS). METHODS: A total of 273 patients (135 in the aceclofenac group and 138 in the tenoxicam group) entered the study. Eight efficacy variables were assessed: morning stiffness, visual analog pain scale, control of additional paracetamol, modified Schöber's test, C7 line-iliac crest distance, lateral flexion of the spine, thoracic expansion, and occiput-wall distance. RESULTS: Seven of the 8 variables improved significantly in both groups, with no differences between the 2 groups in any variable at the end of the study. Six percent of patients taking aceclofenac and 5% of patients taking tenoxicam withdrew because of unsatisfactory therapeutic action. Forty-two adverse events possibly or probably related to treatment were observed in the aceclofenac group and 37 in the tenoxicam group. However, only 2.2% of patients in the aceclofenac group and 1.4% in the tenoxicam group withdrew for this reason. CONCLUSION: Aceclofenac and tenoxicam are similar in terms of safety and effectiveness; and aceclofenac, 100 mg orally twice daily, is a safe, effective, and convenient treatment for active AS.

Administration, Oral↗
PubMedDate not supplied

[Ankylosing spondylitis (Bechterew) and tissue antigen HLA-B 27. II. HLA-B 27 negativity in classical clinical ankylosing spondylitis: no independent nosological entity].

The question, whether HLA-B27-negative patients with classical ankylosing spondylitis (AS) belong to a separate nosological entity, was studied by a standardized analysis of 12 clinical, 8 radiological and 6 laboratory criteria in 95 cases, including 7 with HLA-B27-negativity, who reinforced international criteria for classical AS. The results showed neither definite clinical nor radiological, or laboratory differences between the HLA-B27 negative and positive group. We conclude, that existence or absence of the tissue antigen HLA-B27 has no influence on inflammatory activity of skeletal or soft tissue manifestations of the disease. The group of HLA-B27-negative patients who fulfill the criteria of classical AS does therefore not seem to form a separate nosological entity.

HLA Antigens↗
PubMedDate not supplied

[Ankylosing spondylitis (Bechterew) and tissue antigen HLA-B27. III, Heredity of ankylosing spondylitis (Bechterew)].

A family with known accumulation of ankylosing spondylitis (AS) was examined clinically, radiologically and by HLA tissue typing. Among 17 individuals of three generations there were four carriers of classical AS, all HLA-B27-positive. Five carriers of HLA-B27 were clinically and radiologically healthy, but three of them were below the age of 30, thus still being at risk of developing AS. The numerical relation between first degree relatives with and without HLA-B27 was 10:7. Genotype reconstruction of the great grandparents lead to the conclusion, that they were carriers of two different haplotype combinations, HLA-1/HLA-B27 and HLA-2/HLA-B27. Both haplotype combinations proved to be associated with AS. Among the offsprings of these great grandparents the combination of HLA-2 with HLA-B27 occurred in 3 of the 4 ankylosing spondylitics and in four of the six healthy HLA-B27-carriers. The question whether a haplotype combination of HLA-2 and HLA-B27 leads to an increased risk for AS cannot be decided without further systematic genotype determinations.

HLA Antigens↗
PubMed1997

Preliminary core sets for endpoints in ankylosing spondylitis. Assessments in Ankylosing Spondylitis Working Group.

An international working group was formed to select core sets to be used as endpoints in clinical trials in ankylosing spondylitis (AS). The results of the first steps of the selection of these core sets are described. The definition of the settings for which the core set will be intended are defined. The methods used to select the core sets were a combination of literature search, nominal group discussions, and plenary discussions. The following settings were defined: disease controlling antirheumatic therapy (DC-ART), symptom modifying antirheumatic drugs (SMARD)/physical therapy, and clinical record keeping. Over 110 variables used as endpoints in AS were found in the literature. The preliminary core set for DC-ART consists of physical function, pain, spinal mobility, patient global assessment, peripheral joints/entheses, x-ray spine. The selected core set for SMARD/physical therapy includes physical function, pain, spinal mobility, spinal stiffness, and patient global assessment. The core set for clinical record keeping includes all measures of the SMARD/physical therapy core set completed by peripheral joints/entheses, and acute phase reactants. Three preliminary core sets for AS have been defined. Further research will be performed to select specific measures for all domains.

Antirheumatic Agents↗