RESEARCH - Adjunctive Kineret in patients with active RA despite MTX, Arava, or cyclosporin-A monotherapy

July 8, 2008

Rheumatology Advance Access published online on June 28, 2008

Rheumatology, doi:10.1093/rheumatology/ken223

Adjunctive anakinra in patients with active rheumatoid arthritis

despite methotrexate, or leflunomide, or cyclosporin-A monotherapy: a

48-week, comparative, prospective study

Abstract

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.

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Not an MD

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