Fatigue in patients with ankylosing spondylitis: A comparison with the general population and associations with clinical and self‐reported measures

Objective

To investigate 1) levels of fatigue in patients with ankylosing spondylitis (AS) compared with the general population; 2) the relationships between fatigue and demographic, self‐reported, and clinical measures; and 3) the performance of both a generic and a disease‐specific measure of fatigue.

Methods

Patients with AS (n = 152) were compared with people from the general population (n = 2,323). Fatigue was assessed by the Short Form 36 (SF‐36) vitality scale and the fatigue item of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Other measures of self‐reported health included BASDAI for disease activity, Bath Ankylosing Spondylitis Functional Index for functional abilities, and the SF‐36 for mental health. Clinical measures comprised Bath Ankylosing Spondylitis Metrology Index for joint mobility and erythrocyte sedimentation rate and C‐reactive protein as inflammatory markers. The explanatory power of demographic, self‐reported, and clinical measures was examined in a block regression model.

Results

The mean ± SD SF‐36 vitality score was 43 ± 24 in the patients and 60 ± 21 in the general population (P < 0.001). The SF‐36 vitality and the BASDAI fatigue scores were consistently associated with measures of mental health and disease activity. Clinical measures did not show explanatory power. A cutoff at 70 mm on the BASDAI fatigue item implied specificity of 0.77 and sensitivity of 0.82.

Conclusion

Self‐reported measures of disease activity and mental health contributed significantly to explain fatigue, whereas clinical measures of inflammation and joint mobility did not. The BASDAI fatigue item reached acceptable sensitivity and specificity with a cutoff at 70 mm when using the low vitality scores of SF‐36 as an external indicator.

     

Efficacy and safety of infliximab in patients with ankylosing spondylitis: Results of a randomized,placebo‐controlled trial (ASSERT)

Objective

The signs and symptoms of ankylosing spondylitis (AS) respond inadequately to nonsteroidal antiinflammatory drugs, corticosteroids, and disease‐modifying antirheumatic drugs in quite a number of patients. Tumor necrosis factor inhibitors have demonstrated success in reducing AS disease activity in a limited number of clinical trials. The objective of this multicenter, randomized, placebo‐controlled study was to evaluate the efficacy and safety of infliximab in patients with AS.

Methods

Patients were randomly assigned to receive infusions of placebo or 5 mg/kg infliximab at weeks 0, 2, 6, 12, and 18. Efficacy was assessed using the ASsessment in Ankylosing Spondylitis (ASAS) International Working Group criteria, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), night pain, patient's global assessment, the Bath Ankylosing Spondylitis Functional Index (BASFI), the Bath Ankylosing Spondylitis Metrology Index (BASMI), chest expansion, the Mander enthesis index, the total swollen joint index, the C‐reactive protein level, and the Short Form 36 (SF‐36) health survey questionnaire. The primary end point in this study was the proportion of patients with a 20% improvement response according to the ASAS International Working Group criteria (ASAS20 responders) at week 24.

Results

Of the 357 patients screened, 201 were assigned to receive 5 mg/kg infliximab and 78 were assigned to receive placebo. After 24 weeks, 61.2% of patients in the infliximab group were ASAS20 responders compared with 19.2% of patients in the placebo group (P < 0.001). Clinical benefit was observed in patients receiving infliximab as early as week 2 and was maintained over the 24‐week study period. Patients receiving infliximab also showed significant improvements in the BASDAI, BASFI, BASMI, chest expansion, and physical component summary score of the SF‐36. Adverse events were reported by 82.2% of patients receiving infliximab and by 72.0% of patients receiving placebo; however, most adverse events in both treatment groups were mild or moderate in severity.

Conclusion

Infliximab was well tolerated and effective in a large cohort of patients with AS during a 24‐week study period.

     

Use of a numerical rating scale as an answer modality in ankylosing spondylitis–specific questionnaires

Objectives

To determine the agreement of scores on the original visual analog scale (VAS) or Likert scale of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), and Dougados Functional Index (DFI) with scores on a numerical rating scale (NRS). To assess the reproducibility and responsiveness of the instruments with the original scale and NRS.

Methods

Five hundred thirty‐six patients with ankylosing spondylitis from the Netherlands, Mexico, and Switzerland completed a questionnaire in which all questions from the BASDAI, BASFI, and DFI were presented twice in random order with an 11‐point NRS and either a 10‐cm VAS (BASDAI and BASFI) or a 5‐point Likert scale (DFI). Agreement of scores using Bland‐Altman plots and intraclass correlation coefficients (ICCs), reproducibility using ICCs, and responsiveness were assessed.

Results

Large variability between the scores on the original scales and the NRS was found in individual questions of all 3 questionnaires, although total scores showed ICCs of at least 0.88. Reproducibility of all answer modalities showed low ICCs in individual questions, but moderate to good ICCs in total scores (Dutch group 0.62–0.89; Mexican group 0.53–0.72). Moderate to large effects (0.48–1.04) were found in responsiveness scores in the 3 questionnaires. No major differences in reproducibility and responsiveness between the answer modalities were found.

Conclusion

Although large variability between the scores on the original answer scales and the NRS was observed, the BASDAI, BASFI, and DFI can be administered with an NRS, which does not show important differences compared with the original scales.

     

Juvenile‐onset ankylosing spondylitis is associated with worse functional outcomes than adult‐onset ankylosing spondylitis

Objective

To compare functional outcome of patients with juvenile‐onset ankylosing spondylitis (JoAS; defined as AS with symptom onset before 16 years of age) with that of patients with adult‐onset AS (AoAS) and to identify variables associated with a poor functional outcome of JoAS.

Methods

A cross‐sectional study was performed of 326 JoAS patients who participated in a postal survey conducted by the Spondylitis Association of America. This cohort was compared with 2,021 AoAS patients who participated in the same survey. Simple and multiple logistic regression analyses were performed to identify differences with respect to clinical features, demographic features, and functional outcome (defined by the Bath Ankylosing Spondylitis Functional Index [BASFI]) between the 2 groups. A validation cohort of 255 AS patients was also surveyed.

Results

The mean ± SD BASFI score (controlled for disease duration) for JoAS was 51.3 ± 1.5 compared with 46.4 ± 0.6 for AoAS (P < 0.0001). Multiple logistic regression identified only age (P < 0.0001) and income status (P < 0.0001) as factors associated with functional impairment.

Conclusion

It appears that JoAS is a progressive disease and is associated with significant delay in diagnosis and worse functional outcome compared with AoAS. Furthermore, women do worse than men with JoAS. This would argue for the importance of early diagnosis and treatment of AS, particularly in the subgroup of patients with JoAS.

     

Mental health status and leisure‐time physical activity contribute to fatigue intensity in patients with spondylarthropathy

Objective

To examine the relationship between disease‐related variables, leisure‐time physical activity (LTPA), and mental health status with fatigue severity in patients with spondylarthropathy (SpA).

Methods

Sixty‐six SpA patients completed questionnaires assessing disease activity (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]), functional ability (Bath Ankylosing Spondylitis Functional Index), and health‐related quality of life (Short Form 36). LTPA patterns, demographics, and disease‐related data were obtained by interview. A clinical examination determined tender point count. Fatigue was assessed with the BASDAI fatigue item.

Results

The mean BASDAI fatigue score was 5.5 (SD = 2.7) with 59% of the sample obtaining a score ≥5. Disease activity, functional disability, and worse mental health contributed to greater fatigue (R² = 0.56). The relationship between exercise duration and fatigue intensity was moderated by mental health status. For patients with poorer mental health scores, exercise did not influence fatigue severity. However, for patients reporting better mental health status, engaging in more LTPA decreased fatigue severity.

Conclusion

In addition to increased disease activity and functional disability, greater fatigue severity in SpA is associated with poorer mental health status. Integrating regular leisure physical activity into the comprehensive treatment of SpA may be useful for modulating fatigue.

     

Is disease severity in ankylosing spondylitis genetically determined?

Objective

To assess the role of genes and the environment in determining the severity of ankylosing spondylitis.

Methods

One hundred seventy‐three families with >1 case of ankylosing spondylitis were recruited (120 affected sibling pairs, 26 affected parent–child pairs, 20 families with both first‐ and second‐degree relatives affected, and 7 families with only second‐degree relatives affected), comprising a total of 384 affected individuals. Disease severity was assessed by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and functional impairment was determined using the Bath Ankylosing Spondylitis Functional Index (BASFI). Disease duration and age at onset were also studied. Variance‐components modeling was used to determine the genetic and environmental components contributing to familiality of the traits examined, and complex segregation analysis was performed to assess different disease models.

Results

Both the disease activity and functional capacity as assessed by the BASDAI and the BASFI, respectively, were found to be highly familial (BASDAI familiality 0.51 [P = 10⁻⁴], BASFI familiality 0.68 [P = 3 × 10⁻⁷]). No significant shared environmental component was demonstrated to be associated with either the BASDAI or the BASFI. Including age at disease onset and duration of disease as covariates made no difference in the heritability assessments. A strong correlation was noted between the BASDAI and the BASFI (genetic correlation 0.9), suggesting the presence of shared determinants of these 2 measures. However, there was significant residual heritability for each measure independent of the other (BASFI residual heritability 0.48, BASDAI 0.36), perhaps indicating that not all genes influencing disease activity influence chronicity. No significant heritability of age at disease onset was found (heritability 0.18; P = 0.2). Segregation studies suggested the presence of a single major gene influencing the BASDAI and the BASFI.

Conclusion

This study demonstrates a major genetic contribution to disease severity in ankylosing spondylitis. As with susceptibility to ankylosing spondylitis, shared environmental factors play little role in determining the disease severity.

     

Clinical and imaging efficacy of infliximab in HLA–B27–Positive patients with magnetic resonance imaging–determined early sacroiliitis

Objective

To evaluate the efficacy of infliximab in HLA–B27–positive patients with magnetic resonance imaging (MRI)–determined early sacroiliitis, using both clinical and MRI assessments.

Methods

Forty patients with recent‐onset inflammatory back pain, as assessed by the Calin criteria, HLA–B27 positivity, clinical disease activity as measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), pain and morning stiffness, and magnetic resonance imaging (MRI)–determined sacroiliac joint bone edema were randomized in a double‐blind manner to receive infliximab 5 mg/kg or placebo at 0, 2, 6, and 12 weeks. MRI scans were performed at baseline and 16 weeks and scored by 2 observers (blinded to both the order of the scans and to treatment group), using the Leeds scoring system. Clinical assessments included the BASDAI, the Bath Ankylosing Spondylitis Functional Index (BASFI), the Ankylosing Spondylitis Quality of Life (ASQoL) instrument, the ASsessment in Ankylosing Spondylitis International Working Group criteria (ASAS) for improvement, and markers of inflammation.

Results

The mean reduction in the total MRI score from week 0 to week 16 was significantly greater in infliximab‐treated patients compared with placebo‐treated patients (P = 0.033). On average, significantly more lesions resolved in the infliximab group (P < 0.001), while significantly more new lesions developed in the placebo group (P = 0.004). Significantly greater improvement in the infliximab group versus the placebo group was also observed for changes from week 0 to week 16 in the BASDAI (P = 0.002), BASFI (P = 0.004), and ASQoL (P = 0.007) scores. Responses according to the ASAS criteria for 40% improvement, the ASAS criteria for 20% improvement in 5 of 6 domains, and ASAS partial remission were achieved by 61%, 44%, and 56% of infliximab‐treated patients, respectively. Infliximab was well tolerated, and no serious adverse events were observed.

Conclusion

Infliximab was an effective therapy for early sacroiliitis, providing a reduction in disease activity by week 16. This study is the first to show that infliximab is effective for reducing clinical and imaging evidence of disease activity in patients with MRI‐determined early axial spondylarthritis.

     

Physical function and health-related quality of life of Spanish patients with ankylosing spondylitis

OBJECTIVE: To determine the physical function and the quality of life (QOL) of Spanish patients with ankylosing spondylitis (AS), and to study the reliability of the Spanish version of the Bath Ankylosing Spondylitis Functional Index (BASFI). METHODS: Clinimetric variables, including Spanish BASFI (test-retest), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), QOL instruments (Short Form 36 [SF-36] and European Quality of Life Questionnaire [EuroQol]), Bath Ankylosing Spondylitis Metrology Index (BASMI), and chest expansion, were assessed. RESULTS: A total of 92 patients were included: 69 males (75%), age (mean +/- SD) 40.7 +/- 9.1 years, and disease duration 11 +/- 7.8 years. The scores (mean +/- SD) were (from 0 the best to 10 the worst): BASFI 4.3 +/- 2.4; BASDAI 4.5 +/- 2.2; global SF-36 5.5 +/- 2.1; SF-36 physical function 3.8 +/- 2.5; SF-36 physical scale 4.9 +/- 2.7; SF-36 mental scale 3.7 +/- 2.7; SF-36 physical role limitations 5.6 +/- 4.4; SF-36 general health 5.5 +/- 2.1; SF-36 pain 5.4 +/-2.8; SF-36 vitality 5.1 +/- 2; EuroQoL rating scale 3.9+/-2.1; EuroQol health profile (from 0 the best to 2 the worst) 0.6 +/- 0.4; and BASMI 4.7 +/- 1.6. Significant association was found between BASFI and SF-36 physical function domain (r = 0.75, R(2) = 0.56, P < 0.0001). BASFI Cronbach's alpha was 0.92, Spearman's rho = 0.91, P < 0.0001. CONCLUSIONS: Physical function and QOL are deteriorated in AS. The physical domain is more impaired than the mental one. The SF-36 and the health profile of the EuroQol may be used as generic instruments to measure health-related QOL. Spanish BASFI index is a reliable instrument.     

Risk factors for functional limitations in patients with long‐standing ankylosing spondylitis

Objective

To identify risk factors for functional limitations in patients with ankylosing spondylitis (AS) of at least 20 years' duration.

Methods

Patients with AS for ≥20 years were enrolled in the cross‐sectional component of the Prospective Study of Outcomes in AS. All patients had clinical evaluations and completed questionnaires on functional limitations and potential risk factors. Functional limitations were assessed using the Bath Ankylosing Spondylitis Functional Index (BASFI; score range 0–100, higher scores indicate more limitations) and the Health Assessment Questionnaire for the Spondylarthropathies (HAQS). Risk factors included demographic characteristics, duration of AS, smoking status, number of comorbid medical conditions, recalled level of recreational activity in teens and twenties, occupational physical activity throughout life (rated 1 = little, 2 = moderate, 3 = heavy, and weighted by the number of years in each job), and history of AS in a first‐degree relative.

Results

The 326 patients (74% men) had a mean ± SD age of 55.0 ± 10.7 years, a mean duration of AS symptoms of 31.7 ± 10.2 years, and a mean BASFI score of 40.7 ± 25.6. BASFI scores increased with higher lifetime occupational physical activity (r = 0.31; P < 0.0001), the number of comorbid conditions (r = 0.25; P < 0.0001), and the duration of AS (r = 0.12; P = 0.04). BASFI scores were higher among current smokers compared with former/nonsmokers (55.5 versus 38.9; P = 0.0002), and among nonwhites compared with whites (49.9 versus 39.3; P = 0.02). In multivariable analyses, lifetime occupational physical activity, current smoking, education level, number of comorbid conditions, and family history were significantly associated with BASFI scores. The same risk factors were associated with the HAQS.

Conclusion

Functional limitations in patients with AS for ≥20 years are greater among those with a history of more physically demanding jobs, more comorbid conditions, and among smokers, and are less severe among those with higher levels of education and a family history of AS.

     

Improvement in hemoglobin levels in patients with ankylosing spondylitis treated with infliximab

Objective

Anemia is a common complication in patients with inflammatory diseases such as ankylosing spondylitis (AS). This post hoc analysis of a large, randomized, placebo‐controlled trial examined the effect of infliximab on hemoglobin levels, physical function, and fatigue in patients with AS.

Methods

Patients received infliximab 5 mg/kg (n = 188) or placebo (n = 68) at weeks 0, 2, 6, 12, and 18. Hemoglobin, interleukin‐6 (IL‐6), and C‐reactive protein (CRP) levels, fatigue (visual analog scale [VAS]), physical function (Bath Ankylosing Spondylitis Functional Index [BASFI]), and disease activity were evaluated at baseline and week 24. Anemia was defined as a hemoglobin level <12 gm/dl for women and <13 gm/dl for men.

Results

At baseline, 11 placebo group patients (16.2%) and 37 infliximab group patients (19.7%) had anemia. Of these, more infliximab‐treated patients achieved normal hemoglobin levels at week 24 compared with patients receiving placebo (70.3% versus 27.3%; P = 0.0155). Infliximab‐treated patients had significant improvements in mean hemoglobin concentration (0.7 gm/dl versus ?0.3 gm/dl), BASFI score (?2.1 versus ?0.2), and fatigue VAS score (?2.4 versus ?0.4) compared with placebo patients (P < 0.001). Multiple regression analyses showed that improvements in hemoglobin level were significantly and independently associated with improvements in physical function and fatigue. Infliximab‐treated patients with elevated CRP or IL‐6 levels at baseline were more likely than those with low levels to have improvement in hemoglobin levels.

Conclusion

Infliximab treatment significantly decreased the proportion of AS patients with anemia and improved hemoglobin levels compared with placebo. Improvement in hemoglobin level was independently associated with improvements in physical function and fatigue.

     

Serum levels of matrix metalloproteinase 3 and macrophage colony‐stimulating factor 1 correlate with disease activity in ankylosing spondylitis

Objective

To assess the usefulness of measuring serum matrix metalloproteinase 3 (MMP‐3) and macrophage colony‐stimulating factor (M‐CSF) in patients with ankylosing spondylitis (AS).

Methods

Serum levels of MMP‐3 and M‐CSF were measured in AS patients who did and did not receive infliximab treatment. These were compared with those of 28 healthy subjects.

Results

In the group of AS patients not treated with biologics, both M‐CSF and MMP‐3 correlated with the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) values, but not with each other. Logistic regression analysis showed that MMP‐3 values were high in those with severely active disease. Infusions of infliximab in AS patients led to a significant decrease in the values of the BASDAI as well as the serum MMP‐3, but no change in the serum M‐CSF values.

Conclusion

MMP‐3 and M‐CSF are potentially useful markers of AS disease activity.

     

Yoga lifestyle intervention reduces blood pressure in HIV‐infected adults with cardiovascular disease risk factors*

Objective

People living with HIV infection are at increased risk for developing cardiovascular disease (CVD). Safe and effective interventions for lowering CVD risk in HIV infection are high priorities. We conducted a prospective, randomized, controlled study to evaluate whether a yoga lifestyle intervention improves CVD risk factors, virological or immunological status, or quality of life (QOL) in HIV‐infected adults relative to standard of care treatment in a matched control group.

Methods

Sixty HIV‐infected adults with mild–moderate CVD risk were assigned to 20 weeks of supervised yoga practice or standard of care treatment. Baseline and week 20 measures were: 2‐h oral glucose tolerance test with insulin monitoring, body composition, fasting serum lipid/lipoprotein profile, resting blood pressures, CD4 T‐cell count and plasma HIV RNA, and the Medical Outcomes Study Short Form (SF)‐36 health‐related QOL inventory.

Results

Resting systolic and diastolic blood pressures improved more (P=0.04) in the yoga group (−5 ± 2 and −3 ± 1 mmHg, respectively) than in the standard of care group (+1 ± 2 and+2 ± 2 mmHg, respectively). However, there was no greater reduction in body weight, fat mass or proatherogenic lipids, or improvements in glucose tolerance or overall QOL after yoga. Immune and virological status was not adversely affected.

Conclusion

Among traditional lifestyle modifications, yoga is a low‐cost, simple to administer, nonpharmacological, popular behavioural intervention that can lower blood pressure in pre‐hypertensive HIV‐infected adults with mild–moderate CVD risk factors.

     

Health‐related quality of life of patients with psoriatic arthritis: A comparison with patients with rheumatoid arthritis

Objective

To compare health‐related quality of life (QOL) between patients with psoriatic arthritis (PsA) and patients with rheumatoid arthritis (RA), using the Medical Outcomes Study Short Form health survey (SF‐36) and the Health Assessment Questionnaire (HAQ).

Methods

Both the SF‐36 and the HAQ were administered to 107 PsA patients attending the University of Toronto Psoriatic Arthritis Clinic between January 1 and December 31, 1994, and to 43 RA patients attending a University of Toronto–affiliated RA clinic during the same period. Standardized assessments of disease activity and severity were also performed at each clinic visit. Logistic regression analysis was used to compare health‐related QOL between PsA and RA.

Results

Both patient populations experienced lower physical health compared with that of a general population sample. The RA patients demonstrated more active inflammatory disease at the time of assessment than the PsA patients. The PsA patients were younger, and more were men. Logistic regression analyses showed that patients with PsA reported higher levels of vitality than patients with RA, even after adjusting for the observed differences in clinical and demographic characteristics. PsA patients, however, reported more role limitations due to emotional problems and more bodily pain after adjusting for the difference in vitality and other covariates.

Conclusions

Although both patient populations experienced reduced QOL, there were some meaningful differences in how the 2 conditions affect health‐related QOL. Further, it appeared that there may be unique disabilities associated with the psoriasis dimension of PsA.

     

Validation of a rheumatoid arthritis health‐related quality of life instrument,the CSHQ‐RA

Objective

To test the validity and reliability of a newly developed disease‐specific multidimensional quality of life instrument: the Cedars‐Sinai Health‐Related Quality of Life Instrument (CSHQ‐RA).

Methods

A total of 350 rheumatoid arthritis (RA) patients were asked to complete the CSHQ‐RA at 2 time points (4 weeks apart). Patients also completed the Medical Outcomes Study Short Form 36 (SF‐36) and the Stanford Health Assessment Questionnaire (HAQ) Disability Index (DI) at the second time point. Construct validity was tested, using Pearson's correlations, by comparing subscale scores on the CSHQ‐RA to those obtained from the mental component summary (MCS) and physical component summary (PCS) of the SF‐36. HAQ DI scores were used to assess the discriminant validity of the CSHQ‐RA. Intraclass correlation coefficients (ICCs) were used to assess test–retest reliability.

Results

Response rates for the first and second survey were 83% (291) and 93% (276), respectively; 84% of respondents were women, and mean age was 57 years. Mean scores ± SDs on instruments were: HAQ 0.73 ± 0.69; MCS 49 ± 12; and PCS 33 ± 11. Pearson's correlations between the CSHQ‐RA subscale scores and the SF‐36 scores ranged from 0.55 to 0.76 (P < 0.001). Analysis of variance indicate that scores on the CSHQ‐RA discriminated between levels of physical disability as measured by the HAQ (P < 0.001). Test–retest reliability was demonstrated in the instrument's subscale scores (ICC 0.70–0.90).

Conclusion

These results support the construct validity, discriminant validity, and reliability of the CSHQ‐RA as a measure that captures the impact of RA on patients' health‐related quality of life.

     

Efficacy of celecoxib,a cyclooxygenase 2–specific inhibitor,in the treatment of ankylosing spondylitis: A six‐week controlled study with comparison against placebo and against a conventional nonsteroidal antiinflammatory drug

Objective

To evaluate the short‐term efficacy of celecoxib, a cyclooxygenase 2–specific inhibitor, in the treatment of ankylosing spondylitis (AS).

Methods

The study was a 6‐week randomized, double‐blind, placebo‐controlled trial with 3 treatment arms: placebo, ketoprofen 100 mg twice daily, and celecoxib 100 mg twice daily. Patients who had AS according to the modified New York criteria, without peripheral synovitis and with active disease (pain ≥40 mm on a 100‐mm visual analog scale [VAS] and an increase in pain of at least 30% after nonsteroidal antiinflammatory drug withdrawal) were eligible for study. Primary outcome measures were change in pain intensity (VAS) and change in functional impairment (Bath Ankylosing Spondylitis Functional Index [BASFI]).

Results

Of the 246 randomized patients, 76 were allocated to receive placebo, 90 ketoprofen, and 80 celecoxib. There were no statistically significant differences between treatment groups at study entry. During the 6 weeks of the study, the decrease in pain and functional impairment was greater in the active treatment groups than in the placebo group, with a trend in favor of celecoxib when the 2 active treatments were compared. The mean changes were −13 mm, −21 mm, and −27 mm (P = 0.006) for pain and 1, −6, and −12 (P = 0.0008) for BASFI score in the placebo, ketoprofen, and celecoxib groups, respectively. During treatment, the number of patients reporting epigastric pain was 6 (8%), 13 (14%), and 10 (13%) in the placebo, ketoprofen, and celecoxib groups, respectively.

Conclusion

The results of this study confirm the clinically relevant antiinflammatory effect of celecoxib at a 200‐mg daily dosage, with significant improvement of both pain and function in patients with AS.

     

Spirituality,well‐being,and quality of life in people with rheumatoid arthritis

Objective

To evaluate spirituality, well‐being, and quality of life (QOL) among people with rheumatoid arthritis (RA).

Methods

Questionnaires assessing positive and negative affect, depression, QOL and spirituality were completed. Disease activity was assessed by rheumatologic examination.

Results

Women (n = 62) had a mean (± SD) age of 53.0 (± 13.0) years with 12 (± 13) swollen and tender joints (STJ). Men (n = 15) were 61.9 (± 13.0) years with 7 (± 11) STJ. Disease activity was associated (P < 0.05) positively with depression (r = 0.23), pain (r = 0.26), poorer self‐ratings of health (r = 0.29) and physical role limitations (r = 0.26). Spirituality was associated directly with positive affect (r = 0.26) and higher health perceptions (r = 0.29). In multiple regression, spirituality was an independent predictor of happiness and positive health perceptions, even after controlling disease activity and physical functioning, for age and mood.

Conclusion

Spirituality may facilitate emotional adjustment and resilience in people with RA by experiencing more positive feelings and attending to positive elements of their lives.

     

Could the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) be a valid measure of disease activity in patients with psoriatic arthritis?

Objective

To determine whether the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) could be a valid indicator of disease activity in psoriatic arthritis (PsA).

Methods

Patients with PsA identified from a disease‐register and case‐note review answered a questionnaire by mail (n = 133); some patients (n = 86) consented to examination. In a second sample of 47 consecutive clinic attendees with PsA, logistic regression examined the independent contribution of BASDAI to disease activity, as judged by treatment decisions at that time.

Results

BASDAI correlated highly with patient perception of disease activity (r = 0.739) and there was no significant effect of the pattern of disease (axial or peripheral) on this relationship. However, only physician perception of disease activity was significantly associated with high or low disease activity (odds ratio 18.4, 95% confidence interval 2.9–118.3). BASDAI, patient perception, and erythrocyte sedimentation rate failed to contribute significantly to the model.

Conclusion

BASDAI performs similarly for axial and peripheral PsA but does not correlate well with external indicators of disease activity, such as treatment decisions.

     

Systemic lupus erythematosus in a multiethnic lupus cohort (LUMINA). XVII. Predictors of self‐reported health‐related quality of life early in the disease course

Objective

To determine the baseline factors predictive of self‐reported health‐related quality of life (HRQOL) early in the course of systemic lupus erythematosus patients (SLE) from a multiethnic LUMINA (Lupus in Minorities: Nature versus nurture) cohort.

Methods

LUMINA patients with ≥2 visits were studied. Self‐reported HRQOL was examined with the 8 subscales and 2 summary measures (the Physical Component Summary [PCS], and the Mental Component Summary [MCS]) of the Short Form 36 (SF‐36). Bivariable and multivariable analyses were done with the PCS, MCS and 8 subscales as the dependent variables. The analyses were performed including and excluding the corresponding SF‐36 measure from the independent variables. Age, sex, and ethnicity were included in all models. Time was modeled in all regressions.

Results

A total of 1,351 visits (346 patients [80 Hispanics‐Texas, 34 Hispanics‐Puerto Rico, 126 African Americans, and 106 Caucasians]) were included in these analyses. Mean ± SD PCS and MCS scores were 36.7 ± 12.0 and 46.6 ± 11.5, respectively. The scores for the eight subscales of the SF‐36 were also lower than those for the general population. Baseline SF‐36 measures were highly predictive of subsequent HRQOL. In the same set of regressions, older age was found to consistently predict poor self‐reported HRQOL whereas fibromyalgia, helplessness, fatigue, and abnormal illness‐related behaviors were also predictive, but less consistently. Estimated adjusted variances in these regressions ranged from 23% (Role‐Emotional [RE]) to 43% (Physical Functioning [PF]).

Conclusion

In patients with SLE, poor baseline HRQOL was highly predictive of subsequent poor HRQOL. Other predictive variables of poor functioning were primarily psychological/behavioral and socioeconomic‐demographic.

     

Domains of health‐related quality of life important to patients with giant cell arteritis

Objective

To determine aspects of quality of life (QOL) important to people with giant cell arteritis (GCA).

Methods

We explored the domains of QOL affected by GCA in audiotaped focus groups. We then created an Importance Rating Questionnaire (IRQ) by constructing questions related to the domains most frequently mentioned. Of 214 GCA patients to whom the IRQ was sent, 145 (68%) responded. We calculated frequencies of responses and then ranked items by the proportion selecting the top category of importance and also according to a mean item rank. We compared the domains of QOL covered by the IRQ with those in the Short Form 12 (SF‐12).

Results

The highest rated QOL item was “losing sight in both eyes permanently.” Of the top 20 items, 12 were in domains not covered directly by the SF‐12.

Conclusion

We have identified aspects of QOL important to GCA patients. Assessment of QOL in GCA should include vision and other domains that are not included in standard QOL questionnaires.

     

Health‐related quality of life in systemic sclerosis: A systematic review

Objective

A number of studies (all n <200) have assessed health‐related quality of life (HRQOL) in patients with systemic sclerosis (SSc), but no systematic review of the effect of SSc on HRQOL has been done. The objective of this study was to systematically review the literature on HRQOL in SSc measured using the Medical Outcomes Trust Short Form 36 (SF‐36).

Methods

A comprehensive search was conducted in August 2007 using Medline, CINAHL, and EMBase to identify original research studies reporting SF‐36 scores of SSc patients. Selected studies were reviewed and characteristics of the study samples and SF‐36 data were extracted. Bayesian meta‐analysis and meta‐regression were performed to obtain pooled estimates of SF‐36 physical component summary (PCS) and mental component summary (MCS) scores for all patients as well as by limited and diffuse disease status.

Results

Twelve data sets with a total of 1,127 SSc patients were included in the systematic review. HRQOL was impaired in patients with SSc, with pooled SF‐36 PCS scores being more than 1 SD below the general population (38.3; 95% credible interval [95% CI] 35.2, 41.5) and pooled SF‐36 MCS scores being ～0.5 SDs below the general population (46.6; 95% CI 44.2, 49.1). SF‐36 PCS scores were 3.5 points (95% CI ?1.0, 8.0) lower in patients with diffuse compared with limited disease.

Conclusion

This study provides robust evidence of the presence and magnitude of impairment in HRQOL in patients with SSc. Although the impairment appears greater in physical health, mental health impairment is also reported.