Background/Purpose: Certolizumab pegol (CZP) is a PEGylated Fab’ fragment of a humanized anti-TNF antibody with high affinity to TNF. It brings rapid improvement of the signs and symptoms of RA and it has been shown that attainment of clinical response at first 12 week predict better longterm outcomes. Musculoskeletal ultrasound (US) has been proved to be useful at assessing synovitis precisely in patients with RA. There are few reports, however, that verify the early response to CZP in RA patients by US and whether early US assessment of synovitis can predict future clinical response is unclear. In the present study we describe the early response to CZP in RA patients by US examination and ascertain whether US is useful for predicting future clinical response.

Methods: Seventeen patients with RA were treated with CZP. Patients were treated with subcutaneous CZP 400 mg at weeks 0, 2, 4 followed by 400mg every 4 weeks or 200mg every 2 weeks. The mean age of patients was 52.2 years old and the mean disease duration was 6.0 years. The mean disease activity at baseline (week 0) was 4.67 and 23.2 for 28-joint disease activity score (DAS28) and simplified disease activity index (SDAI), respectively. The mean modified health assessment questionnaire (mHAQ) was 0.49. Twelve patients (71%) were naïve to biologic agents. Fifteen (88%) and 7 (41%) patients were treated with methotrexate and glucocorticoids concurrently. At baseline and weeks 2, 4 and 12, US examination was performed at bilateral MCP, PIP, IP, and wrist joints. Gray-scale (GS) and pulse Doppler (PD) signal was recorded in each joint using semi-quantitative score (0 to 3). The sum of these scores obtained from each joint was used as GSUS and PDUS score.

Results: At weeks 0, 2, 4, and 12, mean GSUS score was 23.5, 20.1, 16.4 and 15.5, respectively. Mean PDUS score at weeks 0, 2, 4, and 12 was 14.4, 10.5, 10.7 and 9.8, respectively. Both GSUS and PDUS score were improved significantly as early as 2 weeks after treatment (p=0.0428 and 0.0119) and gradually reduced during study period. At week 12, both of DAS28 and SDAI were significantly improved than those at baseline (3.42 and 11.6, p=0.0029 and 0.0007, respectively).  Clinical response was evaluated as achievement of DAS remission (DAS<2.6), and we classified 4 patients (24%) in whom DAS remission was achieved at week 12 as “responders”. The US assessment at week 2 was compared between CZP-treated patients (responders vs non-responders at week 12). At week 2, three patients out of responders (75%) showed marked reduction of PDUS score to less than 50% of baseline (PDUS 50 response). By contrast, in the 13 patients of non-responders at week 12, only one patient (7.7%) attained PDUS 50 response. Thus, in responders at week 12, the proportion of early US responders (PDUS 50 response at week 2) was significantly higher than that in non-responders (75% vs 7.7%, p=0.0223).

Conclusion: Early response to CZP in patients with RA were confirmed by US examination. Early US assessment of synovitis can predict future clinical response in CZP treatment.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/ultrasound-assessment-of-early-response-to-certolizumab-pegol-can-predict-future-response-in-patients-with-rheumatoid-arthritis/