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EDITOR [email protected] | ADVERTISING [email protected] 12 JUNE 2015 HUGO WILCKEN Recommendations for managing health and pregnancy in women with systemic lupus erythematosus and antiphospholipid syndrome have been presented at the European League Against Rheumatism annual congress in Rome. Developed by an international expert panel, the evidence-based recommendations cover family planning, assisted reproduction, pregnancy and menopause in women with either or both of the conditions. “APS and SLE disproportionately affect women, typically starting when they are at their most fertile, and leaving women at risk of reduced fertility and pregnancy complications,” says lead author Dr Laura Andreoli, a rheumatologist from the University of Brescia in Italy. “Women often develop these conditions before they have had the chance to have children or complete their family; physicians must ensure optimal management includes best-practice measures to reduce these risks from the onset of disease and throughout pregnancy.” Patients planning a pregnancy should be assessed for disease activity, serology, hypertension and drug use, with an emphasis on hydroxychloroquine and antiplatelet/anticoagulant therapy, the guidelines say. Other key recommendations are: • Women with SLE and/or APS may be candidates for contraception based on their disease activity and thrombotic risk, in particular the presence of antiphospholipid antibodies; • Fertility preservation methods, including gonadotropin-releasing hormone (GnRH) analogues should be considered before using alkylating agents; • Assisted reproduction techniques can be safely used in patients with stable or inactive disease, provided preventive measures are offered to limit the risk of flare and/or thrombosis; • Disease activity, serological markers and renal function parameters are useful to monitor for obstetrical adverse outcomes and disease flares during pregnancy. • Fetal monitoring is similar to high- risk pregnancies in the general population, with fetal ECG indicated for suspected dysrhythmia, particularly in patients with positive anti-RO and/or anti-La; • Cancer screening should be similar to the general population, with particular vigilance for cervical pre-malignancies if exposed to immunosuppressive therapy; • HPV vaccination should be considered in women with stable or inactive disease; • Hydroxychloroquine, glucocorticoids (oral or IV), azathioprine, cyclosporine-A, tacrolimus and IV immunoglobulin can be used to prevent or manage SLE flares during pregnancy. For this abstract, click here. What do you think? Click here to comment New family planning guidelines for SLE and APS PLEASE SEE THE PRIMARY ADVERT FOR PBS INFORMATION AND REFER TO THE PRODUCT INFORMATION BEFORE PRESCRIBING. CLICK HERE FOR ACCESS TO PRODUCT INFORMATION. Reference: 1. ENBREL Approved Product Information. Pfizer Australia Pty Limited, 38–42 Wharf Road, West Ryde NSW 2114. ® Registered trademark Pfizer. Medical Information: 1800 675 229. www.pfizer.com.au. P10393 May 2015 PFE0052/RU1 Experience Success 1Experience Success 1 ^ ^ ACR 20 achieved by 59% of RA patients at 6 months. 1

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  • EDITOR [email protected] | ADVERTISING [email protected] 12 JUNE 2015

    HUGO WILCKEN

    Recommendations for managing health and pregnancy in women with systemic lupus erythematosus and antiphospholipid syndrome have been presented at the European League Against Rheumatism annual congress in Rome.

    Developed by an international expert panel, the evidence-based recommendations cover family planning, assisted reproduction, pregnancy and menopause in women with either or both of the conditions.

    “APS and SLE disproportionately affect women, typically starting when they are at their most fertile, and leaving women at risk of reduced fertility and pregnancy complications,” says lead author Dr Laura Andreoli,

    a rheumatologist from the University of Brescia in Italy.

    “Women often develop these conditions before they have had the chance to have children or complete their family; physicians must ensure optimal management includes best-practice measures to reduce these risks from the onset of disease and throughout pregnancy.”

    Patients planning a pregnancy should be assessed for disease activity, serology, hypertension and drug use, with an emphasis on hydroxychloroquine and antiplatelet/anticoagulant therapy, the guidelines say.

    Other key recommendations are:• Women with SLE and/or

    APS may be candidates for contraception based on their

    disease activity and thrombotic risk, in particular the presence of antiphospholipid antibodies;

    • Fertility preservation methods, including gonadotropin-releasing hormone (GnRH) analogues should be considered before using alkylating agents;

    • Assisted reproduction techniques can be safely used in patients with stable or inactive disease, provided preventive measures are offered to limit the risk of flare and/or thrombosis;

    • Disease activity, serological markers and renal function parameters are useful to monitor for obstetrical adverse outcomes and disease flares during pregnancy.

    • Fetal monitoring is similar to high-risk pregnancies in the general

    population, with fetal ECG indicated for suspected dysrhythmia, particularly in patients with positive anti-RO and/or anti-La;

    • Cancer screening should be similar to the general population, with particular vigilance for cervical pre-malignancies if exposed to immunosuppressive therapy;

    • HPV vaccination should be considered in women with stable or inactive disease;

    • Hydroxychloroquine, glucocorticoids (oral or IV), azathioprine, cyclosporine-A, tacrolimus and IV immunoglobulin can be used to prevent or manage SLE flares during pregnancy.

    For this abstract, click here.What do you think?Click here to comment

    New family planning guidelines for SLE and APS

    PLEASE SEE THE PRIMARY ADVERT FOR PBS INFORMATION AND REFER TO THE PRODUCT INFORMATION BEFORE PRESCRIBING. CLICK HERE FOR ACCESS TO PRODUCT INFORMATION. Reference: 1. ENBREL Approved Product Information. Pfi zer Australia Pty Limited, 38–42 Wharf Road, West Ryde NSW 2114. ®Registered trademark Pfi zer. Medical Information: 1800 675 229. www.pfi zer.com.au. P10393 May 2015 PFE0052/RU1

    Experience Success1†

    Experience Success1^ÂCR 20 achieved by 59% of RA patients at 6 months.1

    mailto:[email protected]:[email protected]://www.6minutes.com.au/homehttps://b-com.mci-group.com/Abstract/Statistics/AbstractStatisticsViewPage.aspx?AbstractID=255234Click here to commenthttp://www.6minutes.com.au/getmedia/72475118-dc7a-441c-8dbc-9b30b082f3ed/Enbrel-Full-PI-June.aspxhttp://www.6minutes.com.au/rheumatologyupdate/home

  • EDITOR [email protected] | ADVERTISING [email protected] 12 JUNE 2015

    Rheumatologists head for RomeCLARE PAIN

    While patients with arthritis might have difficulty scaling the seven hills of Rome, their physicians are out in force, presenting a wealth of research at the European League against Rheumatism (EULAR) 2015 Conference.

    The perennial question of whether vitamin D helps in osteoarthritis is addressed by a two-year Australian trial of 413 knee OA patients with low 25-hydroxy vitamin D, randomised to either a monthly capsule of 50,000 IU D3 or placebo.

    The answer seems to be no, with no statistically significant changes in total knee pain WOMAC scores, or in MRI-assessed knee tibial cartilage volume.

    The persistence of treatment with various biologics prescribed for RA is examined in an Australian Medicare database study, led by Roche in conjunction with the Royal Hobart Hospital.

    Median time to stopping

    treatment was 39 months for tocilizumab, 32 months for abatacept, 21 months for subcutaneous anti-TNFs and 3 months for infliximab. Eighty

    percent of patients taking tocilizumab as second-line therapy were still taking the biologic at one year, compared with 45% of people taking abatacept and 49% of people

    on subcutaneous anti-TNFs.If a patient has OA-related

    knee pain, which joints are the next ones likely to become sore? According to a Tasmanian study, such patients are at increased risk of shoulder pain some four years down the track.

    “Spread of joint pain over time is not random, with shoulders the most common painful joint following knees,” say the authors. Having leg muscle weakness seems to be key to the spread of pain to the shoulders, the authors add.For these abstracts and more, click here.What do you think?Click here to comment

    PLEASE SEE THE PRIMARY ADVERT FOR PBS INFORMATION AND REFER TO THE PRODUCT INFORMATION BEFORE PRESCRIBING. CLICK HERE FOR ACCESS TO PRODUCT INFORMATION. References: 1. ENBREL Approved Product Information. 2. Emery P, et al. Arth Rheum 2010; 62(3): 674-82. Pfi zer Australia Pty Limited, 38–42 Wharf Road, West Ryde NSW 2114. ® Registered trademark Pfi zer. www.pfi zer.com.au. P10393 May 2015 PFE0052/RU2

    Early RA (

  • EDITOR [email protected] | ADVERTISING [email protected] 12 JUNE 2015

    Too much screen time affects boys’ bonesCLARE PAIN

    Teenage boys who spend lots of time in front of the television or computer screen are at risk of poorer bone health, research has found.

    A study carried out in Norway found the same does not apply to girls, which it suggests can be explained by their different body fat distribution.

    Researchers looked at how much time 15- to 18-year-olds say they spend sitting in front of screens at the weekend, with between four and six hours being the most common amount of time in the 1000 students questioned.

    This is followed by more than six hours in boys, but between two and four hours in girls.

    The school pupils’ bone mineral density was analysed along with their height, weight and details of their lifestyles.

    The team found that while girls in the four- to six-hour category had the highest bone mineral density, the amount of time spent in front of screens had a negative effect on

    the bone mineral density of boys.“Our study suggests persisting

    associations of screen-based sedentary activities on bone health in adolescence,” the Tromsø-based researchers say.

    “This detrimental association should therefore be regarded as of public health importance and

    followed closely, since improvement of peak bone mass is possible.”

    While time spent in front of the TV and computer games was linked to lower levels of physical activity, one in five (20 per cent) of the girls and a quarter (26 per cent) of the boys who said they spent more than four hours a day in front of a screen at

    the weekend also spent more than fours hours a week doing sport.

    Researchers add that it is possible students either under or over-reported their screen times because of social pressures or gender differences.

    They say girls tend to perform several activities at once - spending time in front of the TV or computer screen as well as on their phones or carrying out other tasks, such as hobbies or crafts.

    Meanwhile male adolescents are less likely to report spending lots of time on the phone, texting and instant messaging, and it might therefore have been easier for boys to give a precise amount of time spent in front of a screen.

    The study, which was led by the UiT The Arctic University of Norway, is published in the online journal BMJ Open.Leisure time computer use and adolescent bone health—findings from the Tromsø Study, Fit Futures: a cross-sectional studyWhat do you think?Click here to comment

    Patient group concerned about biosimilarsCLARE PAIN

    Patients are nervous about the introduction of biosimilars and need to be well-informed by their treating physicians, according to a presentation given at EULAR 2015 by the Committee for People with Arthritis/Rheumatism (PARE).

    With the original biologics now starting to reach the end of their patent periods, biosimilars are being developed which are intended to be “highly similar” to the original biologics, says Diana Skingle, Chair of the PARE Standing Committee.

    The problem is, that, with the complex molecules involved and the equally complex production processes required to produce them, it is virtually impossible for a biosimilar to be identical to the original biologic medicine – which is known as the ‘reference medicine’, she explains.

    Even the reference medicines themselves have a degree of natural variability, and biosimilars will also exhibit natural variability, she says.

    The European Union has led the world in setting up a legal framework and regulatory pathway for biosimilars with the first biosimilar being approved by the European commission in 2006, so they are not new, she adds.

    “There is an opportunity for these biosimilars to be available at a lower cost than the original medicines, possibly making them more widely accessible to patients

    and offering more treatment options to physicians. The PARE Committee welcomes these new possibilities.”

    But there are patient concerns: one being that pressure may be put on clinicians by health providers and insurers to prescribe the newer cheaper biologics on the basis of cost.

    Another concern is the European Medical Agency’s statement that “some studies that have been

    carried out with the reference medicine may not need to be reproduced” for the biosimilar. This may mean that biologics are approved after only very short or limited trials, she suggests

    Pharmacovigilance is of particular concern, she remarks, and the EU has said that, for biosimilars, the brand name should be used, to enable “clear identification and traceability to support adverse drug reaction reporting…”

    Many patients are also concerned that physicians may switch them between the reference product and a biosimilar without their consent, says Ms Skingle.

    “As for all medicines, patients need to be able to make fully-informed decisions about whether to take a biologic or a biosimilar,” she says.Biosimilars: What do patients need to consider? What do you think?Click here to comment

    https://twitter.com/rheumaupdatemailto:[email protected]:[email protected]://bmjopen.bmj.com/content/5/6/e006665.full.pdf+htmlhttp://bmjopen.bmj.com/content/5/6/e006665.full.pdf+htmlhttp://bmjopen.bmj.com/content/5/6/e006665.full.pdf+htmlhttp://bmjopen.bmj.com/content/5/6/e006665.full.pdf+htmlhttp://www.6minutes.com.au/rheumatologyupdate/latest-news/too-much-screen-time-affects-boys-bones#commentshttp://www.eular.org/myUploadData/files/Biosimilars_2015.pdfhttp://www.eular.org/myUploadData/files/Biosimilars_2015.pdfhttp://www.6minutes.com.au/rheumatologyupdate/latest-news/patient-group-concerned-about-biosimilars#commentshttps://twitter.com/rheumaupdate

  • EDITOR [email protected] | ADVERTISING [email protected] 12 JUNE 2015

    Experience Success1†

    PBS Information: Authority required for the treatment of adults with severe active rheumatoid arthritis, active ankylosing spondylitis, severe active psoriatic arthritis and severe chronic plaque psoriasis.

    Authority required for the treatment of patients under 18 years with severe chronic plaque psoriasis. Private and public hospital authority required for the treatment of severe active juvenile idiopathic arthritis.

    This product is not listed on the PBS for the treatment of non-radiographic axial spondyloarthritis.Refer to PBS Schedule for full information.

    PLEASE REFER TO THE PRODUCT INFORMATION BEFORE PRESCRIBING. CLICK HERE FOR ACCESS TO PRODUCT INFORMATION. References: 1. ENBREL Approved Product Information. 2. Emery P, et al. Ann Rheum Dis 2012; 71:989-92. Pfi zer Australia Pty Limited, 38–42 Wharf Road, West Ryde NSW 2114. ® Registered trademark Pfi zer. Medical Information: 1800 675 229. www.pfi zer.com.au. P10393 May 2015 PFE0052/RU3

    *Post-hoc analysis. ¥ DAS28 remission 70% vs. 48% in patients