Background/Purpose

In the last few years the introduction of biological agents has radically changed the clinical outcome of patients with Rheumatoid Arthritis (RA). However, no single drug is able to control all patients with RA and it is known that each drug may be poorly effective in a sizable proportion of the treated patients (1). For these reasons, the early identification of clinical responder patients would be a crucial advantage for both a clinical and socioeconomic point of view.

Certolizumab pegol (CZP), a PEGylated, Fc-free anti-TNF, demonstrated a fast response in rheumatoid arthritis (RA). The peculiarity of the clinical response to CPZ at 12 weeks is already predictive of efficacy over time (2,3). Recently, mathematic algorithms, based on classical clinical parameters, have been proposed to predict the clinical response to anti TNF (4).

In the present study we have applied a mathematic algorithm recently proposed (ERI)(4) to predict early response to anti TNF on our cohort of patients treated with CZP.

Objectives: To evaluate the ability of ERI to predict the early response to CZP in RA patients already after the first 4 weeks of treatment

Methods

We retrospectively collected the data of 52 RA patients followed in our unit and treated with CZP. We enrolled for this study 35 patients (72% female; mean age ± SD 56.63±15.58; DAS28 at the onset: 5.77 ±0.90; DAS28 at 12 weeks: 1.99 ± 0.43). The mathematic algorithm ERI utilizing the following parameters: tender Joint, swollen Joint, Illness activity VAS by Physician and patient, pain VAS, ESR and CRP, was applied to calculate the putative responders after one month of treatment (ERI≤0.67)and this value was compared with the DAS28 responders at 3 months. The patients were classified as good responders if they had a delta DAS28≥1.2 (EULAR criteria)

Results

35 out of a total of 52 patients treated with CZP were assessed. 17 patients were excluded because: 3 interrupted CZP due to side effects, 5 had a follow-up inferior to 12 weeks, 9 patients had insufficient data (lost or poor compliance to follow-up) to calculate ERI and/or DAS28. No one had received other biologics prior to the assessment; all had associated a synthetic DMARD to CZP, mainly MTX. Using EULAR criteria we identified 21 responders at week 12, while ERI recognized 23 responders at week 4, with a concordance of 94%. Using EULAR criteria as the gold standard with ERI analysis we observed 1 false negative and 3 false positive subjects.

Conclusion

It is very important to identify subject who are responders to anti TNF agents such as CZP. CZP-treated patients with improvement at week 12 (ΔDAS28≥1.2) have a much higher probability of low disease activity at week 52 (3,5). In our cohort, ERI is a simple formula which can early recognize the CZP-RA responders, already after the first 4 weeks of treatment. In a socio-economic context, early identification of responders could be an opportunity to reduce spending. Moreover, to take advantage of any proposals for reimbursement, even on the part of pharmaceutical companies.

 

References:
1. Kievit W, Ann Rheum Dis 2007

2. Keystone E,. Arthritis Rheum 2008

3. Schiff M Ann Rheum Dis 2009

4. Bazzichi L Rheumatol Int 2010,

5. Curtis JR Arthritis Car Res 2012

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/early-response-indicator-early-predicts-clinical-response-to-certolizumab-in-rheumatoid-arthritis-patients/