Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.
Clinical and Radiological Efficacy of Biologics in Rheumatoid Arthritis Patients Naive or Inadequate Responders to Methotrexate: A Metanalysis.
Audrey, Pierreisnard, Nahema, Issa, Thomas, Barnetche, Christophe, Richez, Thierry, Schaeverbeke
Recently, an overview of Cochrane reviews comparing efficacy and safety of six biologics in rheumatoid arthritis (RA) was published. However, this study did not include tocilizumab, certolizumab and golimumab, and was not stratified based on previous methotrexate (MTX) use. Our objective was to perform a metanalysis of all biologics available in RA into two situations: MTX naive patients and MTX inadequate responders (IR). Furthermore, there are no randomized controlled trials (RCT) comparing biologics head to head. In this study, we performed indirect comparisons of biologics for efficacy.
A comprehensive literature review was performed by searching Medline for RCTs from 1995 to December 2009 and conference abstracts from ACR Annual Scientific Meetings and EULAR's. We included studies evaluating the five anti-TNF, tocilizumab, rituximab and abatacept, in combination with MTX in MTX naive patients and in IR, using the standard dosing regimens of each product. The primary clinical outcome was ACR50 response. Indirect comparisons of biologics were performed for efficacity using the number needed to treat (NNT) for ACR50 criteria. The primary radiological endpoint was the proportion of patients with no progression of total Sharp score at one year. Statistical analyses were based on odds ratio (OR) for efficacy. Using these combined estimates, we calculated the NNT for each product.
22 studies were included, 7 in MTX naive patients and 15 in IR. In MTX naive patients, biologics therapy showed significantly increased efficacy compared to MTX with OR for achieving an ACR50 response: OR: 2.11 (95%IC: 1.85, 2.41).
In IR, the same OR was 4.79 (95% IC: 3.49,6.59). The NNT for ACR50 for etanercept were: 5 for MTX naive patients and 3 for IR; for adalimumab were: 7 and 3, respectively; for infliximab were: 7 and 4, respectively; for abatacept were: 7 into the two groups; for rituximab were: 5 into the two groups; for tocilizumab: 4 for IR; for certolizumab were: 4 for IR. NNT were not evaluable for golimumab as the confidence intervals for the risk comprised null or negatives values. The radiographic primary endpoint is shown in figure 2.
Response to biologic therapy in combination with MTX, compared to MTX alone was significant in IR and MTX naive group, but to a lesser extent in the MTX naive group. This difference could be explained by a relative efficacy of MTX in MTX naive patients. Interestingly, patients treated by anti-TNF therapy had significantly less radiograpghic progression than those with cellular therapy, in MTX naive patients.
To cite this abstract, please use the following information:
Audrey, Pierreisnard, Nahema, Issa, Thomas, Barnetche, Christophe, Richez, Thierry, Schaeverbeke; Clinical and Radiological Efficacy of Biologics in Rheumatoid Arthritis Patients Naive or Inadequate Responders to Methotrexate: A Metanalysis. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :2267