|
RHEUMATOLOGIC DISORDERS Arthur
A. Schuna, Section Advisor
Treatment of early RA with infliximab is beneficial
Key point: The addition of infliximab
(Remicade—Centocor) to methotrexate resulted in a superior
clinical response compared with the addition of sulfasalazine and
hydroxychloroquine to methotrexate in patients with early rheumatoid
arthritis (RA) who did not respond to 3 to 4 months of methotrexate
monotherapy.
Finer points: van Vollenhoven and colleagues
published results of the Swefot (Swedish Pharmacotherapy) study, a
randomized, multicenter, active controlled trial involving 258 patients
with early RA, in the August 8 Lancet. Eligible patients
included those with a history of RA for less than a year who failed to
respond to 3 to 4 months of methotrexate monotherapy. Patients with a
disease-activity score of more than 3.2, based on a 28-joint count
(DAS28), after a trial of methotrexate were randomized to either
sulfasalazine 1,000 mg twice daily plus hydroxychloroquine 400 mg daily
(n = 130) or infliximab 3 mg/kg given at weeks 0, 2, 6, and every 8
weeks thereafter (n = 128). Both regimens were given in addition to the
methotrexate regimen of 20 mg per week and dose adjustments for the
agents were permitted during the trial.
At 1 year, 39% of patients in the infliximab group compared with 25%
of patients in the sulfasalazine and hydroxychloroquine group achieved a
good response, defined as a decrease in the DAS28 score by 1.2 and a
resulting DAS28 score of 3.2 or lower (P = 0.0160). In
addition, significantly more patients randomized to infliximab achieved
American College of Rheumatology (ACR)20 and ACR50 responses compared
with the sulfasalazine and hydroxychloroquine group (ACR20 42% vs. 28%,
P = 0.0266; ACR50 25% vs. 15%, P = 0.0424). The rate
of adverse events was similar between the two groups; 21% of patients in
the infliximab group experienced at least one adverse event compared
with 25% of patients in the sulfasalazine and hydroxychloroquine
group.
What you need to know: This study found more
patients achieved favorable treatment outcomes when infliximab was added
to methotrexate when compared with a triple regimen of methotrexate,
hydroxychloroquine, and sulfasalazine. It is important to note, however,
that 1 of every 4 patients achieved good response to the triple drug
regimen; both approaches should be considered valid treatment options
for patients. In 2008, ACR published recommendations for the use of
nonbiologic and biologic disease-modifying antirheumatic drugs (DMARDs)
for patients with RA. For patients with high disease activity and
features of poor prognosis (poor functional status, extra-articular
disease, positive rheumatoid factor, positive anticyclic citrullinated
peptide antibodies or bony erosions), anti-TNF drugs plus methotrexate
may be considered if cost or insurance limitations are not a factor. ACR
recommends methotrexate in combination with other nonbiologic DMARDs for
patients who have cost or insurance restrictions.
What your patients need to know: Patients who do not
respond adequately to methotrexate alone need to be aware that multiple
options are available that may result in better treatment outcomes.
Combination therapy with TNF alpha inhibitors or nonbiologic DMARDs may
provide improvement when methotrexate alone fails to achieve adequate
outcomes.
Sources
Related resources on www.pharmacist.com
Joe Sheffer (jsheffer@aphanet.org)
Posted October 27, 2009
|
