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    • Before treatment patients were checked for the

    2018-10-25

    Before treatment, patients were checked for the presence of dihydroergotamine virus (HBV) surface antigen (HBsAg), hepatitis C virus(HCV) antibody, and latent tuberculosis (TB) by chest X-ray and Quantiferon TB Gold, QFT-G, Cellestis Limited, Carnegie, Victoria, Australia. HBV and HCV viral loads were checked on a regular basis and antiviral treatment was provided as indicated. Patients with latent TB were treated concomitantly with 9-month isoniazid prophylaxis.
    Results
    Discussion Biologics are increasingly used in the treatment of psoriasis. Results from the pivotal trials show a comparable PASI 75 response of adalimumab and ustekinumab and a head-to-head study showed a more favorable PASI response of ustekinumab compared to etanercept. However, failure in adalimumab or ustekinumab does not preclude the treatment response of etanercept, and vice versa. Despite initial satisfactory results, biologic switch is often encountered in daily clinical practice, but studies on the efficacy between biologic switchers were mostly conducted in patients with rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis, and mainly among TNF blockers. In time sequence, etanercept followed by adalimumab and ustekinumab is approved and reimbursed for the treatment of psoriasis in Taiwan and most countries. Thus, the switch first from etanercept to adalimumab, and then to ustekinumab is most often encountered. Most switches are due to either primary or secondary drug failure, with fewer switches due to adverse events. In most countries, biologics are only reimbursed in patients with psoriasis who have failed conventional treatment. However, the exact criteria for reimbursement is different in regards to the need of baseline PASI and previous treatment. The interpretation of failure and contraindication to prior treatment may also be different. Thus, it is important to understand the actual effectiveness in these highly selected patients, both for biologics-naïve and previous biologics users. We previously reported our experience of switch from etanercept to adalimumab. The result is less favorable compared to the other reports of similar switches. In this current study, a similar lower PASI response was found in patients who switched from etanercept to adalimumab (i.e., second biologic in Table 2 and Figure S5): 30% of patients had at least PASI 50 and 20% of patients had at least PASI 75 at Week 12; 36% of patients had at least PASI 50 and only 9% of patients had at least PASI 75 at Week 24. There are fewer studies on switching from TNF blockers to ustekinumab. In one Spanish study, 63% and 50% patients who had previous exposure to TNF blockers had at least PASI 75 response at Week 12 and Week 24, respectively, which were lower compared with TNF blocker-naïve patients, 85% of whom achieved at least PASI 75 at each comparable time point. In another Danish study, no statistically significant differences were noticed between TNF blocker-naïve and TNF blocker-exposed patients. In the Active Comparator (CNTO1275/Enbrel) Psoriasis Trial (ACCEPT) clinical trial, among patients who did not have a response to etanercept, 49% had at least 75% improvement in the PASI score after crossing over to 90 mg of ustekinumab for 12 weeks. Our study showed less favorable results: only 26% of patients and 21% of patients had at least PASI 75 at Week 16 and Week 28, respectively. Regarding the efficacy of ustekinumab based on body weight, in the Spanish study, patients weighing <100 kg and treated with the 45 mg dose had significantly higher PASI 50 and response rates at Week 24 than heavier patients treated with 90 mg, which was inconsistent with previous pivotal studies which showed similar response rates between the two groups. Most pivotal trials in Western countries showed that higher dosages were needed for heavier patients, and the prescribing information of ustekinumab also used 100 kg as the cut-off value. However, in one Asian pivotal study, 70 kg (approximating the median Taiwanese population weight) was used as the cut-off value based on the subgroup analysis, and no apparent effect was found on the efficacy of ustekinumab under the dosage of 45 mg. The present study also used 70 kg as the cut-off value and yielded similar results: neither body weight nor BMI had a substantial influence on the effectiveness of ustekinumab, which may have been biased by the small sample size.