Table 5

 Reports on treatment trials with etanercept and similar agents

Ref NoNo of patients (systemic onset)Study design, treatment durationDescriptionSevere adverse events (SAE)/withdrawals because of adverse events (w)
669 (22)3 month open label study (A) followed by 4 month double blind controlled study (B)At the end of (A) a 30%, 50%, or 70% improvement was reached by 74%, 64%, and 36% of patients. In (B), flare up of disease was more often seen in patients switched to placebo than in those remaining on the drugDepression (n = 1), gastroenteritis/flu-like syndrome (n = 1)
Urticaria (no SAE, w)
2058 (12)(B) Open label extension study up to 24 monthsLong term extension study in 51 patients of (A+B) and 7 patients of (A). In 48 patients treated for 2 years a response rate of 30%, 50%, and 70% was observed in 81%, 79%, and 67% of patients. Five of 12 systemic onset patients terminated prematurely compared with five of 46 non-systemic onset patientsVaricella with aseptic meningitis and cervical subluxation (n = 1, w); sepsis (n = 1, w); abdominal pain (n = 1); soft tissue infection (n = 1); peritonitis/appendicitis (n = 1); postoperative wound infection (n = 1); type 1 diabetes (n = 1); dental abscess
710 (4)Case series, treatment duration 4 or 12 monthsImprovement of morning stiffness by 93%, swollen joint count by 40%, tender joint count by 88%, ESR by 53%. Two patients achieved clinical remissionNo SAE observed, no withdrawals
1022 (7)Open prospective trial for up to 24 monthsImprovement of swollen joint count by 49%, tender joint count by 94%, loss of morning stiffnessOnly minor adverse events observed, no withdrawals
97 (1)6 month open studyCombination methotrexate and etanercept treatment showing high efficacy in all 6 non-systemic JIA patients and no response in the other patientNo SAE observed, no withdrawals
128 (5)Retrospective case note review, treatment duration 3–10 monthsIncreased dosage was used in patients failing the standard dose regimen not yielding any success in all but 2 patientsNot observed
1110 (2)Case series, treatment duration 4 to >12 months10 patients treated with etanercept showed a comparable response to 14 patients treated with infliximab. Approximately 60% reached 75% improvementNo SAE and no withdrawals in patients treated with etanercept
845 (45)Survey, treatment duration 1–27 monthsSurvey of systemic onset patients treated in the USA: 21 patients showed a sufficient response, 13 a weak response, and 11 no or a marginal response. Dose escalation in 10 patients produced no significant improvementNo SAEs observed
1361 (22)Open label prospective study, mean duration of treatment 13 monthsMaximum 30%, 50%, and 70% response rate were observed at 3 months (in 73%, 54%, and 38% declining to 39%, 36%, and 26% at 12 months of treatment. Response rate significantly lower in systemic onset patients13 patients discontinued because of adverse events: pancytopenia, psychiatric disorders, uveitis flares, retrobulbar optic neuropathy, headache, dysaesthesia, the occurrence of Crohn’s disease, vasculitic skin rash, major weight gain, appendicular abscess, pregnancy