Safety Of Antirheumatic Drugs Research Articles

The Safety of Antirheumatic Drugs.

Drug therapy for rheumatic diseases has changed fundamentally in recent decades with the introduction of many new agents. As these drugs may have to be taken for many years, and many of them are of similar efficacy, their safety profiles play an important role in therapeutic decisionmaking. This review is based on pertinent literature retrieved by a selective search on the safety profiles of selected antirheumatic drugs. Non-steroidal antirheumatic drugs, glucocorticoids, conventional disease-modifying drugs such as methotrexate, biological agents, and janus kinase (JAK) inhibitors are all used to treat rheumatic diseases. Register and trial data show that antirheumatic treatments are relatively safe. Infections, in particular, are much less common than initially expected. Cortisone administration is an exception because of its severe long-term sequelae. Biological agents are associated with severe infectious events at a rate of 4-5 events per 100 patient years. Screening before treatment with biological agents has been shown to lower the rate of tuberculosis from 564 to 95 cases per 100 000 patient years. JAK inhibitors have a good safety profile, with respect to infections as well, but there is evidence of their association with cardiovascular problems, malignancies, and thrombosis. A suitable, safe antirheumatic drug can be chosen for each patient in consideration of individual risk profiles. Regular monitoring enables the early detection of adverse effects. The risk profile of JAK inhibitors, in particular, will be studied in further trials.

The safety of antirheumatic drugs

The safety of antirheumatic drugs

Biologics During Pregnancy and Breastfeeding Among Women With Rheumatic Diseases: Safety Clinical Evidence on the Road.

Females are generally more affected by autoimmune diseases, a fact that underlines the relationship with pregnancy and the safety of anti-rheumatic drugs in pregnancy and lactation. Biologic therapies are increasingly prescribed to treat and maintain remission in a significant number of systemic autoimmune rheumatic diseases. The experience with the use of biologics during gestation is extremely lacking because of the observational nature of the available studies and the difficulty in designing proper clinical trials in pregnancy. Among the studied biologics, more information was published on TNFα inhibitors and, in particular, on their potential passage through the placenta and impact on the fetus. Currently, a fragment of anti-TNFα monoclonal IgG, certolizumab pegol, is considered safe with almost no placental transfer. Subsequent observations are suggesting a comparable safety for the soluble TNFα receptor etanercept. Another biologic, eculizumab, the anti-C5a antibody used to treat complement-mediated microangiopathies, is also considered safe due to the unique engineered IgG2/4κ formulation that limits its passage through the placental barrier. Still, long-term data about children born to women treated with biologics in pregnancy are not attainable. Data on breastfeeding are currently available for several biologics. This article reviews the literature available about which drugs are considered safe during pregnancy and lactation, which are not, and on future prospects.

Safety of anti-rheumatic drugs in men trying to conceive: A systematic review and analysis of published evidence

There is limited evidence relating to the impact of disease modifying anti-rheumatic drugs (DMARDs) upon male fertility and peri-conception paternal exposure in men with rheumatic disease. Therefore, we conducted a systematic review of available evidence to update information on this subject and guide paternal counselling. A systematic search of PubMed and Embase was carried out up to September 2017, to find relevant peer-reviewed papers, using keywords for fertility/spermatogenesis/conception, men, and disease modifying or biologic drugs commonly prescribed in patients with rheumatic disease. The search yielded 724 papers, and the titles/abstracts were screened independently by 2 authors, duplicates removed and 233 potentially relevant papers selected for full text review. A total of 84 papers were included in the final analysis which covered the impact on fertility of over 611 male exposures to relevant drugs, and over 5986 pregnancies conceived during paternal exposure to (or within 3 months of stopping) these drugs. Aside from the known adverse impact of cyclophosphamide and sulfasalazine on spermatogenesis, overall there was no firm evidence of harm to fertility or pregnancy outcomes with paternal exposure to anti-TNF therapies, abatacept, rituximab, azathioprine, cyclosporine A, hydroxychloroquine, leflunomide, methotrexate or mycophenolate mofetil. There was no evidence found pertaining to the effects of male exposure to IVIG, tacrolimus, golimumab, anakinra or belimumab on fertility or pregnancy outcomes. These results provide further reassurance as to the safety of many DMARDs for men trying to conceive and will be useful when counselling men about risks of anti-rheumatic drugs to fertility and pregnancies, and following accidental conception.

OP0120 A Systematic Analysis of the Safety of Prescribing Anti-Rheumatic Immunosuppressive and Biologic Drugs in Pregnant Women with Inflammatory Arthritis

BackgroundThe use of anti-rheumatic drugs in pregnancy is often complicated by concerns over their potential for adverse effects. Given that rheumatic diseases often affect women of childbearing age and may...

Biologika in Schwangerschaft und Stillzeit

Over the past years, biological therapies, especially anti-TNF-α antibody therapy has emerged as a treatment approach in patients who have failed to achieve or maintain remission with tradional DMARDs. Women suffering from inflammatory arthritis may need to continue therapy throughout pregnancy and/or in the lactation period, hence the increased concern over the safety of antirheumatic drugs during pregnancy. Anti-TNF agents fall within the US FDA category B concerning fetal risk, indicating that no adequate and well-controlled studies have been conducted in pregnant or lactating women. However, in the last decade, numerous case series and registry data of pregnancies exposed to anti-TNF therapy have accumulated in the literature. According to these data, TNF inhibitor therapies appear to be safe in pregnancy, since no increased risk of malformations has been demonstrated. Ceasing therapy after conception should be considered, but treatment may be continued during pregnancy when indicated.The use of these agents is likely compatible with breast-feeding. The extent of fetal risk is not clarified for exposure to other biologics, such as Rituximab.