Objective To evaluate the efficacy and safety of adalimumab for rheumatoid arthritis failing to respond to disease-modifying anti-rheumatic drugs (DMARDs). Methods The Cochrane Library, PubMed, EMbase, CBM, CNKI, VIP and Wanfang (from the date of their establishments to June 2010) were searched, and journals of relevant fields were retrieved to identify randomized controlled trials (RCTs). The data were analyzed by using RevMan 5.0 software. Results Four RCTs were included, all of which were from abroad and with good methodological quality. The baseline data of each trial were comparable. Meta-analyses showed that there was a significant difference between the adalimumab and the placebo in terms of ACR20, ACR50, ACR70, tender joint count, swollen joint count, patient assessment of pain, patient global assessment of disease activity, doctor global assessment of disease activity, and disability index of the HAQ. There was no difference between the adalimumab and the placebo in terms of serious adverse events, intractable adverse events and serious infection. Conclusion Adalimumab can treat rheumatoid arthritis failing to respond to DMARDs, but clinically the doctor should balance the benefit and the risk of the adalimumab.
Objective To assess the efficacy and safety of adalimumab on plaque psoriasis. Methods We searched the MEDLINE (1966 to December 2009), Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 12, 2009), EMbase (1980 to December 2009), CBM (1978 to December 2009), and CNKI (1979 to December 2009) to collect randomized controlled trials (RCTs) of adalimumab for plaque psoriasis. The language was confined to English and Chinese. We screened the retrieved studies according to the predefined inclusion and exclusion criteria, evaluated the quality of included studies, and performed meta-analyses by using the Cochrane Collaboration’s RevMan 4.2 software. Results Three RCTs involving 1?630 patients with chronic moderate or severe plaque psoriasis were included and assessed. At the end of 4th, 8th, 12th and 16th week, the PASI 75s of subcutaneous injection every other week in adalimumab (EOW) group were obviously higher than that of placebo group and methotrexate group. While at the end of 24th week and 60th week, the PASI 75s showed no difference between adalimumab EOW and placebo group. Twelve weeks after subcutaneous injection each week with adalimumab (QW), PASI 75 was obviously higher than those of placebo and EOW groups. However, at the end of 24th week and 60th week, there was no significant difference between adalimumab QW and placebo followed by adalimumab EOW. At end of week 12-16, there was no difference between adalimumab EOW group and placebo group in the incidence of adverse effects, with the exception of pain on injection site and upper respiration viral infection. At week 12-60, there was no difference between adalimumab QW and EOW groups in the incidence of adverse effects, with the exception of all serious adverse effects. Conclusion The limited evidence indicates that subcutaneous injection of adalimumab every other week for 12-16 weeks is safe and efficient for patients with moderate or severe plaque psoriasis. The efficacy can’t be enhanced when the treatment is prolonged to 24 weeks. The once-a-week protocol has no obvious advantage over every other week protocol. More RCTs are required to verify these conclusions owing to the limitations of the present study.
Therapeutic drug monitoring (TDM) has been more widely used in small molecule agents, such as immuno-suppressants, antiepileptic drugs and antibiotics, with less attention in the field of therapeutic biological agents. Monoclonal drugs represented by tumor necrosis factor alpha (TNF-α) inhibitors have shown a good relationship between exposure and efficacy in clinical studies. There are corresponding guidelines and consensus for the recommendations of TDM based on current research evidence. Therefore, this paper introduced the current evidence, strategies and considerations for TDM in the optimal treatment of adalimumab from the perspective of adalimumab TDM to provide references for the clinical practice of adalimumab TDM.
Anti-tumor necrosis factor-α monoclonal antibody agents have been widely applied in the management of autoimmune diseases. Among them, Adalimumab and Infliximab have been used for years in clinical practice in treating non-infectious uveitis and achieved satisfactory effects and safety. However, no guideline or expert consensus for their usage is available in China currently. It hopefully promotes standardized clinical application of anti-tumor necrosis factor -α monoclonal antibody in treating non-infectious uveitis, together with other senior experts in uveitis, the Ocular Immunology Group of Immunology and Rheumatology Academy in Cross-Straits Medicine Exchange Association form this evidence-based recommendations for clinicians’ reference.