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ABSTRACT: The British Society for Rheumatology Biologics Register (BSRBR) has collected data on adverse events including pregnancies in patients with rheumatoid arthritis treated with anti-tumour necrosis factor (anti-TNF) therapy. The purpose of this report is to summarise the pregnancy outcomes in women treated with anti-TNF in the BSRBR.
Patients were categorised according to anti-TNF exposure as follows: (1) exposure to anti-TNF and to methotrexate (MTX) and/or leflunomide (LEF) at conception (n=21 pregnancies); (2) exposure to anti-TNF at conception (n=50); (3) exposure to anti-TNF prior to conception (n=59); (4) no exposure to anti-TNF (control group; n=10).
Eighty-eight live births in a total of 130 pregnancies were reported in patients who received anti-TNF before or during pregnancy. The rate of spontaneous abortion was highest among patients exposed to anti-TNF at the time of conception (with MTX/LEF 33% and without MTX/LEF 24%). This compared with 17% spontaneous abortions in those with prior exposure to anti-TNF and 10% spontaneous abortions in the control group. Ten terminations were performed.
Although the results to date have been promising, no firm conclusions can be drawn about the safety of anti-TNF during pregnancy and, without further evidence, guidelines which suggest these drugs should be avoided at the time of conception cannot yet be changed.
Annals of the rheumatic diseases 02/2011; 70(5):823-6. · 8.11 Impact Factor
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ABSTRACT: Anti-tumour necrosis factor (TNF)alpha treatments improve outcome in severe rheumatoid arthritis (RA) and are efficacious in psoriasis and psoriatic arthritis. However recent case reports describe psoriasis occurring as an adverse event in patients with RA receiving anti-TNFalpha therapy.
We aimed to determine whether the incidence rate of psoriasis was higher in patients with RA treated with anti-TNFalpha therapy compared to those treated with traditional disease-modifying antirheumatic drugs (DMARDs). We also compared the incidence rates of psoriasis between the three anti-TNFalpha drugs licensed for RA.
We studied 9826 anti-TNF-treated and 2880 DMARD-treated patients with severe RA from The British Society for Rheumatology Biologics Register (BSRBR). All patients reported with new onset psoriasis as an adverse event were included in the analysis. Incidence rates of psoriasis were calculated as events/1000 person years and compared using incidence rate ratios (IRR).
In all, 25 incident cases of psoriasis in patients receiving anti-TNFalpha therapy and none in the comparison cohort were reported between January 2001 and July 2007. The absence of any cases in the comparison cohort precluded a direct comparison; however the crude incidence rate of psoriasis in those treated with anti-TNFalpha therapy was elevated at 1.04 (95% CI 0.67 to 1.54) per 1000 person years compared to the rate of 0 (upper 97.5% CI 0.71) per 1000 person years in the patients treated with DMARDs. Patients treated with adalimumab had a significantly higher rate of incident psoriasis compared to patients treated with etanercept (IRR 4.6, 95% CI 1.7 to 12.1) and infliximab (IRR 3.5, 95% CI 1.3 to 9.3).
Results from this study suggest that the incidence of psoriasis is increased in patients treated with anti-TNFalpha therapy. Our findings also suggest that the incidence may be higher in patients treated with adalimumab.
Annals of the rheumatic diseases 05/2008; 68(2):209-15. · 8.11 Impact Factor
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ABSTRACT: Low vitamin D status is prevalent among South Asians living in the UK. The relationship, however, between serum 25-hydroxyvitamin D level (25OHD), serum parathyroid level (PTH) and bone mass in this group of women is unknown. The aim of this study was to determine the association between serum PTH, 25OHD and bone mass in a population based sample of young UK South Asian women.
Names of South Asian women aged 18 to 36 years of Pakistani origin living in the Greater Manchester area were identified from primary care registers using validated computer software. Subjects were invited to attend for (i) a blood test for assessment of serum calcium (Ca), albumin, PTH and 25OHD and (ii) for bone mineral density (BMD) scanning using the following: areal BMD at the hip (femoral neck, total hip) and lumbar spine using dual X-ray absorptiometry (Hologic QDR 4500), and volumetric BMD at the distal radius using peripheral quantitative computed tomography (Norland Stratec XCT 2000). Linear regression was used to determine the association between serum 25OHD, PTH and BMD at the different sites with adjustments made for age.
In all, 78 women (mean age 29.2 years) were included in the analysis. Mean serum Ca level was 2.42 mmol/l, 25OHD, 7.9 ng/ml and PTH, 52.8 pg/ml. The majority of women (94%) had serum 25OHD levels <or=15 ng/ml, while 20 (26%) had evidence of marked deficiency (<or=5 ng/ml). Mean serum PTH level was similar in subjects with a serum 25OHD of 10.1-15 ng/ml and >15 ng/ml, though rose progressively in subjects with levels below 10 ng/ml. Serum 25OHD was positively associated with BMD at the hip and spine while PTH was negatively associated with BMD at the hip and spine. When categorized by serum 25OHD level there was an increase in BMD at the total hip and distal radial site at least up to levels of 15 ng/ml.
Despite widespread recognition, hypovitaminosis D is still prevalent among young UK South Asian women. In these women a decrease in serum 25OHD level <or=15 ng/ml is associated with a progressive reduction in bone mass at the hip and wrist.
Bone 01/2007; 40(1):200-4. · 4.02 Impact Factor
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ABSTRACT: There are few data concerning the occurrence of peak bone mass in women of South Asian origin. The aim of this study was to determine the level of peak bone mass in South Asian women in the UK and to determine whether any observed differences could be explained by differences in body size. Two groups of South Asian women, those of (1) Pakistani Muslim and (2) Gujarati Hindu origin, together with a European group aged 18 to 36 years, were recruited from primary-care population age-sex registers in the Greater Manchester area. They were invited to attend for a detailed interview-assisted lifestyle questionnaire and assessment of height and weight. Bone mass density (BMD) at the hip and lumbar spine was measured by dual energy X-ray absorptiometry (DEXA) scan (Hologic QDR 4500). Volumetric bone density was measured at the distal radius using pQCT (Norland Stratec XCT 2000). Linear regression was used to determine whether any observed differences in the level of bone mass could be explained by differences in body size. A total of 119 European women with a mean age of 30.4 years, 98 Pakistani Muslim women with a mean age of 29.2 years and 20 Gujarati Hindu women with a mean age of 29.2 years had bone density measurements performed. The Europeans were taller and heavier than either South Asian group. Peak BMD was greater among the European than the Pakistani women at all three measuring sites, with the Gujarati women having intermediate values at the hip and lumbar spine. Observed differences disappeared, however, after adjusting for height and weight. There were no differences in volumetric density at the lumbar spine or distal radius between the groups. In summary, there are differences in the level of bone mass between European and South Asian women, though these can be explained by differences in bone size, height or weight.
Osteoporosis International 11/2005; 16(10):1254-62. · 4.58 Impact Factor
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ABSTRACT: There are few data concerning the occurrence of peak bone mass in women of South Asian origin. The aim of this study was to determine the level of peak bone mass in South Asian women in the UK and to determine whether any observed differences could be explained by differences in body size. Two groups of South Asian women, those of (1) Pakistani Muslim and (2) Gujarati Hindu origin, together with a European group aged 18 to 36years, were recruited from primary-care population age-sex registers in the Greater Manchester area. They were invited to attend for a detailed interview-assisted lifestyle questionnaire and assessment of height and weight. Bone mass density (BMD) at the hip and lumbar spine was measured by dual energy X-ray absorptiometry (DEXA) scan (Hologic QDR 4500). Volumetric bone density was measured at the distal radius using pQCT (Norland Stratec XCT 2000). Linear regression was used to determine whether any observed differences in the level of bone mass could be explained by differences in body size. A total of 119 European women with a mean age of 30.4years, 98 Pakistani Muslim women with a mean age of 29.2years and 20 Gujarati Hindu women with a mean age of 29.2years had bone density measurements performed. The Europeans were taller and heavier than either South Asian group. Peak BMD was greater among the European than the Pakistani women at all three measuring sites, with the Gujarati women having intermediate values at the hip and lumbar spine. Observed differences disappeared, however, after adjusting for height and weight. There were no differences in volumetric density at the lumbar spine or distal radius between the groups. In summary, there are differences in the level of bone mass between European and South Asian women, though these can be explained by differences in bone size, height or weight.
Osteoporosis International 01/2005; 16(10):1254-1262. · 4.58 Impact Factor
