Rheumatology News

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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.
Lenalidomide
Revlimid, Celgene
For the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell
transplantation.
Ceftobiprole medocaril sodium
Zevtera , JACE Pharma
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).
Ceftolozane/tazobactam
Zerbaxa , Merck Sharp & Dohme Australia
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.
Nintedanib esilate
Ofev/Vargatef, Boehringer Ingelheim
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.
Budesonide
Cortiment, Ferring Pharmaceuticals
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.
Please consult the full Product Information before prescribing.
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Rheumatology 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 Rheumatology News (Australian
Edition) is sourced from R heumatology News (US Edition)
published by Frontline Medical News.
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High-dose vitamin D increases fall risk in study of 200 patients
BY SHARON WORCESTER
Frontline Medical News
From JAMA Internal Medicine
Older adults treated with high-dose vi-
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 D3 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
D3 and 24,000 IU of vitamin D3 plus 300 mcg
of calcifediol were significantly more likely
than a 24,000 IU dose of vitamin D3 alone to
result in 25-hydroxyvitamin D levels of at least
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.
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 D3 each, and one capsule
containing 300 mcg of calcifediol, which is a
potent liver metabolite of vitamin D.
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
D3, 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.
Methotrexate has a role in treating articular
manifestations of psoriatic arthritis
BY NICOLA GARRETT
Frontline Medical News
From Journal of Rheumatology
Patients 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
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
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.
No relevant conflicts of interest were disclosed.
Rheumatology News • Vol. 4 • No. 1 • 2016
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