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San Diego —The presence of anemia is associated with radiographic progression in patients with rheumatoid arthritis (RA) who are naïve to methotrexate (MTX) therapy and who subsequently receive MTX or tofacitinib, according to data from 2 phase 3 randomized controlled trials presented at the 2017 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting.
“Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA,” wrote lead study investigator Dr Burkhard Moeller from the University Hospital of Bern, Switzerland, and colleagues. “In this post hoc analysis, we explored whether anemia was a predictor of radiographic progression in patients with RA who were treated with tofacitinib.”
Researchers analyzed data obtained from 2 phase 3, randomized, placebo-controlled trials that featured MTX-naïve (n=956) or MTX-inadequate responder ([IR] n=797) patients.
Participants were randomly assigned to receive either 5 or 10 mg of tofacitinib twice a day (monotherapy or with MTX), placebo, or MTX. The Total Sharp Score (mTSS) was used to determine radiographic progression at 4 different points in the study: baseline, 6 months, 12 months, and 24 months.
Investigators found baseline anemia present in 32.6% and 40.3% of MTX-naïve patients and MTX-IR patients, respectively. In patients who were naïve to MTX therapy, baseline anemia was associated with a change in radiographic joint damage (ΔmTSS) at 6 months (difference in ΔmTSS with and without baseline anemia, 0.40; P <.001).
Patients given tofacitinib and patients receiving MTX monotherapy (0.95; P <.005) also showed an increase in ΔmTSS at 6 months from baseline (0.25; P <.05). Researchers found no correlations between anemia at baseline and ΔmTSS in MTX-IR subjects or in either intervention arm at 6, 12, or 24 months.
“These data support the evidence that anemia at baseline is a predictive parameter for joint damage progression in MTX-naïve patients, at least up to M6,” concluded Dr Moeller.
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Moeller B, Finckh A, Scholz G, Shi H, Connell CA, Strengholt S. Baseline anemia as a predictor of radiographic progression in tofacitinib-treated rheumatoid arthritis patients: post hoc analyses from two phase 3 trials. Presented at: ACR/ARHP 2017 Annual Meeting; November 3-8, 2017; San Diego, California. Abstract 436.