Τίτλος:
Adjunctive anakinra in patients with active rheumatoid arthritis despite
methotrexate, or leflunomide, or cyclosporin-A monotherapy: a 48-week,
comparative, prospective study
Περίληψη:
Objective. To assess the efficacy and safety of anakinra (ANK) as an
add-on therapy in RA patients with inadequate response to monotherapy
with non-biological DMARDs.
Methods. A 48-week comparative, prospective study of patients with
active RA [mean 28-joint disease activity score (DAS28): 6.81],
despite MTX (n 48), or LEF (n=42), or CSA (n=38) treatment, in whom ANK
(100 mg/daily SC) was given with corticosteroid cream topical
application.
Results. At 24 and 48 weeks the patient percentages meeting the ACR20
response criteria were 57 and 73%, respectively, 33 and 41% met ACR50,
while 15 and 23% met ACR70. Significant improvements in number of
swollen and tender joints, HAQ, pain, global disease assessment, CRP and
haemoglobin from baseline to 24 and 48 weeks were evident. DAS28
decreased at 24 weeks (-1.68; 95% CI - 1.46, -1.90; P<0.0001), as well
as at study end (-2.24; 95% CI -2.01, -2.47; P<0.0001). Subgroup
analysis revealed a significantly weaker response in terms of pain and
DAS28 in patients treated with concomitant CSA. The most common
ANK-related adverse event was injection-site reaction (29%), being less
frequent in male patients, as well as in patients treated with CSA.
There were 17 withdrawals, 6 of them due to inefficacy. No opportunistic
infections or new safety signals were observed.
Conclusion. Considering the limitations of an open-label study, addition
of ANK appears to be an effective and well-tolerated treatment option
for many RA patients with inadequate responses to non-biologic DMARDs in
clinical practice.
Συγγραφείς:
Karanikolas, G.
Charalambopoulos, D.
Vaiopoulos, G. and
Andrianakos, A.
Rapti, A.
Karras, D.
Kaskani, E. and
Sfikakis, P. P.
