Rheumatology News

NEWS 2

R heumatology N ews • Vol. 4 • No. 1 • 2016

High-dose vitamin D increases fall risk in study of 200 patients BY SHARON WORCESTER Frontline Medical News From JAMA Internal Medicine O lder adults treated with high-dose vi- 30 ng/mL at 6 and 12 months, but lower extremity function did not differ among the groups, the investigators reported in a study published online Jan. 4 in JAMA Internal Medicine.

Although vitamin D supplementation has been proposed as a possible strategy for delaying functional decline because of its effects on muscle strength, the current findings, which are consistent with some prior studies, suggest that high-doses of vitamin D confer no benefit with respect to function decline, compared with a standard-of-care dose of 24,000 IU of D 3 , and that high doses may increase falls in those with a prior fall event. Further research is needed to confirm the findings for daily dosing regimens, as well as to explore the physiology behind a possible detrimental effect of a high monthly bolus dose of vitamin D on muscle function and falls, they concluded. This study was funded by the Swiss National Science Foundation and the VELUX Founda- tions, as well as by investigator-initiated funds from Merck Sharp & Dohme AG, WILD, and DSM Nutritional Products. Dr Bischoff-Ferrari reported receiving speaker fees from and serving on advisory boards for Merck Sharp & Dohme AG, Amgen, WILD, DSMNutritional Products, Roche Diagnostics, Nestle, Pfizer, and Sanofi. in Leeds dactylitis instrument median score, and a significant decrease in the proportion of patients with enthesitis (25.7%). However, the median change in enthesitis score was 0. Response rates did not differ between pa- tients receiving methotrexate 15 mg/week or higher doses, although there was generally a higher proportion who met various response criteria among those taking greater than 15 mg/ week. However, the authors noted that there could be an underestimation of the dose ef- fect because the design of the TICOPA study, which randomised patients to a protocol for tight control of psoriatic arthritis disease activity or standard care, introduced a bias by intention- ally escalating treatment doses in patients who continue to have active disease. The investigators advised that the study results be interpreted in the context of the open-label design of the study, and placed alongside the other observational studies that support its use in psoriatic arthritis.

tamin D as part of a double-blind, ran- domised clinical trial achieved target 25-hydroxyvitamin D levels at 6 and 12 months, but did not achieve the primary end- point of improved lower extremity function. In fact, the highest dose used in the study – 60,000 IU of vitamin D 3 monthly – was associ- ated with an increased risk of falls, according to Dr Heike A. Bischoff-Ferrari of University Hospital Zurich, and her colleagues. In the 200 home-dwelling adults aged older than 70 years who participated in the 1-year study, monthly doses of 60,000 IU of vitamin D 3 and 24,000 IU of vitamin D 3 plus 300 mcg of calcifediol were significantly more likely than a 24,000 IU dose of vitamin D 3 alone to result in 25-hydroxyvitamin D levels of at least

For example, the adjusted changes in Short Physical Performance Battery scores – a measure of walking speed, suc- cessive chair stands, and balance – were 0.17, 0.16, and 0.16 at 6 months in the 24,000 IU, 60,000 IU, and 24,000 IU plus calcifediol groups, respectively, and 0.38, 0.10, and 0.11 at 12 months. However, the incidence of falls was 66.9%, 66.1%, and 47.9% in the groups, re- spectively, and the mean number of falls was higher in the 60,000 IU group (1.47) and 24,000 IU plus calcifediol group (1.24) than in the 24,000 IU group (0.94), they said, not- ing that a similar pattern was observed during study months 0–6 and months 7–12. Study subjects had a mean age of 78 years, 58% were vitamin D deficient with levels of less than 20 ng/mL at baseline, and 13% were severely deficient (levels less than 10 ng/mL). All had experienced a low-trauma fall in the previous 12 months and were thus considered

a high-risk group for vitamin D deficiency and functional decline. Vitamin D supplementa- tion was given via one 5-mL drink solution each month that provided 24,000 IU of vi- tamin D 3 – equivalent to the current recom- mendation of 800 IU/day – plus three placebo capsules; a 5-mL drink solution that provided 60,000 IU of vitamin D 3 – the equivalent of 2000 IU/day – plus three placebo capsules; or a 5-mL placebo drink, two capsules containing 12,000 IU of vitamin D 3 each, and one capsule containing 300 mcg of calcifediol, which is a potent liver metabolite of vitamin D.

Managing Editor

Anne Neilson anne.neilson@elsevier.com Carolyn Ng carolyn.ng@elsevier.com Jana Sokolovskaja j.sokolovskaja@elsevier.com

Methotrexate has a role in treating articular manifestations of psoriatic arthritis

Editor

Designer

Commercial Manager Fleur Gill

fleur.gill@elsevier.com Stephen Yue s.yue@elsevier.com

Account Manager

dose at 12 weeks of at least 15 mg/week in 175, 20 mg/week in 122, and 25 mg/week in 86. The proportions of patients achieving American College of Rheumatology (ACR) outcomes at 12 weeks were 40.8% for ACR20, 18.8% for ACR50, and 8.6% for ACR70. A to- tal of 22.4% achieved minimal disease activity, defined as meeting five of these seven criteria: 0–1 tender joints, 0–1 swollen joints, Psoriasis Area and Severity Index (PASI) of 1 or less or body surface area involvement of 3 or less, patient pain visual analog score (VAS) of 15 or less, patient global disease activity VAS of 20 or less, health assessment questionnaire of 0.5 or less, and 0–1 tender entheseal points. Other improvements that occurred at 12weeks included 27.2% reaching a PASI75, a 62.7%drop in dactylitis incidence, a significant drop of –59.7

BY NICOLA GARRETT Frontline Medical News From Journal of Rheumatology

International Editorial F rontline M edical N ews

P atients with psoriatic arthritis taking metho- trexate demonstrated an improvement in peripheral joint disease, skin disease, enthesitis, dactylitis, and nail disease over 12 weeks in a subanalysis of methotrexate users in the TICOPA (Tight Control of Psoriatic Arthritis) study. Out of the original 206 patients in the open- label, randomised, controlled TICOPA study, the subanalysis involved 188 who received methotrexate in its first 12 weeks. Substudy authors Dr Laura C. Coates and Dr Philip S. Helliwell of the Leeds Institute of Rheumatic and Musculoskeletal Medicine at the Univer- sity of Leeds (England) verified a maximum

Editor in Chief Mary Jo M. Dales Executive Editors Denise Fulton, Kathy Scarbeck Managing Editor Jeff Evans Senior Editors Therese Borden, Catherine Hackett, Gina L. Henderson, Sally Koch Kubetin, Mark S. Lesney, Renée Matthews, Lora T. McGlade, Catherine Cooper Nellist, Terry Rudd, Laura Nikolaides, Mary Ellen Schneider, Heidi Splete Associate Editors Felicia Rosenblatt Black, Mike Bock, Lucas Franki, Richard Franki, Gwendolyn B. Hall, Jane Locastro, Madhu Rajaraman Reporters Patrice Wendling, Bruce Jancin, Michele G. Sullivan, Alicia Gallegos, Mitchel L. Zoler, Doug Brunk, M. Alexander Otto, Deepak Chitnis, Whitney McKnight, Elizabeth Mechcatie, Gregory Twachtman R heumatology N ews is an independent newspaper that pro- vides the practicing specialist with timely and relevant news and commentary about clinical developments in the field and about the impact of health care policy on the specialty and the physician’s practice. The news and information in R heumatology N ews (Australian Edition) is sourced from R heumatology N ews (US Edition) published by Frontline Medical News. The ideas and opinions expressed in R heumatology N ews , Australian Edition do not necessarily reflect those of the Publisher. Elsevier Australia will not assume responsibility for damages, loss, or claims of any kind arising from or related to the information contained in this publication, including any claims related to the products, drugs, or services mentioned herein. Please consult the full current Product Information before prescribing any medication mentioned in this publica- tion. For a digital edition visit elseviermedcomms.com.au To share your feedback with us, please email news.au@elsevier.com ISSN: 2202-221X

No relevant conflicts of interest were disclosed.

NEW DRUGS AND DEVICES LISTING Therapeutic Goods Administration (TGA) New drugs

Indication

Dabigatran etexilate Pradaxa , Boehringer Ingelheim

Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the prevention of recurrent DVT and PE in adults. For the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation. For the treatment of the following infections in adults suspected or proven to be caused by designated susceptible microorganisms: • hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP) • community-acquired pneumonia (CAP). For the treatment of the following infections in adults suspected or proven to be caused by designated susceptible microorganisms: • complicated intra-abdominal infections in combination with metronidazole • complicated urinary tract infections, including pyelonephritis. Indicated in combination with docetaxel for the treatment of patients with locally advanced, metastatic or recurrent non-small cell lung cancer of adenocarcinoma tumour histology after failure of first line chemotherapy. It is also indicated for the treatment of idiopathic pulmonary fibrosis. Indicated in adults for induction of remission in patients with mild to moderate active ulcerative colitis where 5-ASA treatment is not sufficient or not tolerated.

Lenalidomide Revlimid , Celgene

Ceftobiprole medocaril sodium Zevtera , JACE Pharma

Ceftolozane/tazobactam Zerbaxa , Merck Sharp & Dohme Australia

R heumatology N ews , Australian Edition is published by Elsevier Australia

Nintedanib esilate Ofev/Vargatef , Boehringer Ingelheim

ABN 70 001 002 357 475 Victoria Avenue Chatswood NSW 2067, Australia Locked Bag 7500 Chatswood DC NSW 2067 © 2016 Elsevier Inc.

Budesonide Cortiment , Ferring Pharmaceuticals

Please consult the full Product Information before prescribing.

EMRN031601