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According to data from an open-label extension of a randomised, placebo-controlled trial, etanercept is effective for up to 192 weeks in patients with ankylosing spondylitis (AS).

In the original trial (n=277), etanercept was found to reduce the signs and symptoms of AS for up to 24-weeks. A total of 257 patients (92%) elected to continue treatment in the open-label extension phase; those who received placebo in the main trial were crossed over to treatment with etanercept (potentially up to 168 weeks of continuous etanercept treatment), and those who were originally randomised to etanercept continued treatment (up to 192 weeks of continuous treatment). Etanercept was originally administered as two separate doses of 25mg given twice per week, but after week 72 of the extension this was changed to 50mg once weekly. The main findings were as follows:

• The most common adverse effects overall were injection site reactions (22.2%), headaches (20.2%) and diarrhoea (17.5%).

• The exposure-adjusted rate of serious adverse events was 0.08 per patient-year in patients receiving etanercept and 0.07 per patient-year in patients receiving placebo. That most commonly SAE reported by etanercept patients was depression (n = 3), there were two reports each of back pain, malnutrition and fatty liver.

• The exposure adjusted rate of infections was 1.1 per patient-year for patients receiving etanercept and 1.0 per patient-year for patients receiving placebo. The most common infections reported were upper respiratory (45%), sinusitis (16%), flu syndrome (15%) and bronchitis (11%). The rate for serious infections was 0.02 per patient-year. One case of tuberculosis was reported in one patient (0.4%) following 2.8 years of etanercept exposure.

• A total of 71% of patients who received etanercept in the original trial as well as in the open-label extension were ASAS20 (Assessment in Ankylosing Spondylitis) responders at week 96, and 81% were responders at week 192. Placebo patients who switched to etanercept in the OLE showed similar patterns of efficacy maintenance.

The authors conclude that “etanercept was well tolerated for up to 192 weeks in patients with AS, with no unexpected adverse effects or severe adverse effects observed. No deaths were reported. Improvements in the signs and symptoms of AS were maintained for up to 192 weeks”.

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According to the results of this double-blind, randomised equivalence trial, oral prednisolone and naproxen are equally effective in the initial treatment of gout arthritis over 4 days. Equivalence trials are similar to non-inferiority studies and are conducted to show that there is no clinically significant difference between a standard and an experimental treatment. In the trial, 120 primary-care patients in the Netherlands who had confirmed gout (presence of monosodium urate crystals) were randomised to treatment with either prednisolone (35 mg once a day; n=60) or naproxen (500 mg twice a day; n=60), for 5 days. The primary outcome was pain measured on a 100 mm visual analogue scale and the margin for equivalence set at 10%. Analyses were done per protocol and by intention to treat, although the per-protocol analysis results are given in the report as the researcher’s note that the results of the intention-to-treat analyses agree with those of the per-protocol analyses. Data were incomplete for one patient in each treatment group, so per-protocol analyses included 59 patients in each group. The results of the study found:

• After 90 hours the reduction in the pain score was 44.7 mm and 46.0 mm for prednisolone and naproxen, respectively (difference 1.3 mm; 95% CI -9•8 to 7•1), suggesting equivalence.
• The difference in the size of change in pain was 1.57 mm (95% CI -8.65 to 11.78).
• Adverse effects were similar between groups, minor, and resolved by 3 week follow-up.

In a related Comment article, researchers from Hong Kong note some limitations to the trial and say that these results may need to be repeated in larger trials to convince physicians to change existing clinical practice. They conclude:

“Although well designed, Janssens’ study is fairly small and was done in one centre. The general clinician might not be convinced that studies with only 120 patients should change long-established practice. Clearly this study needs to be repeated in other locales with different incidences of gastrointestinal disease. Second, changes in clinical practice often need strong marketing forces, which might not be forthcoming unless drug companies stand to benefit from newer and more expensive drugs. Nevertheless Janssens’ trial will go some way to satisfy both rheumatological purists and front-line pragmatists that short-term oral corticosteroids are as equally effective as NSAIDs in the initial treatment of acute gout and gout-like syndrome.”

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