Adverse events of anti-tumour necrosis factor therapy for ankylosing spondylitis: a retrospective study of 369 Chinese Han population / 中华风湿病学杂志

ABSTRACT

ObjectiveTo evaluate the adverse events occurred during tumour necrosis factor (TNF)-αblocker treatment in Chinese Han population patients with ankylosing spondylitis (AS).MethodsThis study had enrolled 369 Chinese Han population patients with ankylosing spondylitis.They all received TNF-αblocker treatment in the hospital.All 1011 administration were recorded in total.All of them were evaluated for adverse events 2 hours after injection,126 of them had received long-term TNF-α blocker injection,and they were followed-up at week 8,12,52,104.Mild immediate adverse events and long-term adverse events were all counted.SPSS 10.0 software package was used for Fisher's exact test.ResultsThree hundred and sixty-nine patients had 1011 administrations in total,652 had received rhTNFRFc,316 had infliximab,21had etanercept,22 had adalimumab injections.Adverse events 2 hours after injection were17 (2.6％) for rhTNFRFc,12 (3.8％) for infliximab,0 for etanercept,1 (4.5％) for adalimumab.Twenty adverse events were mild(12 for rhTNFRFc,9 for infliximab),5 events were moderate(3 for rhTNFRFc,1 for infliximab,1 for adalimumab),4 events were severe(2 for rhTNFRFc,2 for infliximab).The frequency of adverse events were comparable between rhTNFRFc and Infliximab injection in immediate adverse reactions (P=0.31).One hundred and twenty-six (69 rhTNFRFc,57 infliximab) patients had long-term usage,and were followed-up at week 8,12,52,104,39 patients had adverse reactions20 (51.3％) for rhTNFRFc,19(48.7％) for infliximab.Thirty-seven patients had infectious events(94.9％ ),1 neurological event(2.6％),and 1 patient had tuberculosis relapse (2.6％).Outcomes were comparable with rhTNFRFc and infliximab in long-term usage(P=0.69).ConclusionAttention should be paid to the above events in Chinese Han patients with ankylosing spondylitis who were treated with TNF-α blocker treatment.Special attention should be paid to those patients who are in their third or fourth injection.The occurrence of immediate reaction or long-term adverse events between rhTNFRFc and infliximab are comparable.