NEW YORK (Reuters Health)—Adding prednisone to methotrexate for early rheumatoid arthritis (RA) results in a lower initiation rate of a biologic, better radiographic outcomes and no steroid-related side effects, researchers in the Netherlands say.
Although biological disease-modifying anti-rheumatic drugs (bDMARDs) have led to better control of RA and improved functioning and quality of life, they cost more than conventional synthetic DMARDs, carry a higher risk of severe infections and don’t work well in up to a third of patients, Dr. Mary Safy and colleagues at University Medical Center Utrecht point out in Annals of Rheumatic Diseases, online April 27.1
To help optimize early RA treatment, the team analyzed post-trial follow-up data on 218 participants (60% women, mean age 55) in the CAMERA-II trial, in which patients received methotrexate plus 10 mg prednisone or placebo daily.2 Adding prednisone resulted in a significantly faster reduction in disease activity, less corrosive joint damage after two years of treatment and less frequent initiation of a tumor necrosis factor inhibitor-based treatment.
In the current study, the team looked at whether those improvements persisted after the trial, when prednisone was tapered and stopped. Median post-trial follow up time was 6.7 years for the methotrexate plus prednisone group vs. 6.6 years for methotrexate plus placebo.
Fewer patients initiated a first bDMARD in the group that received methotrexate plus prednisone compared with those who had received methotrexate plus placebo (31% vs. 50%, p=0.003).
At two years post-trial, the median erosion score (as determined by radiographs of hands and feet) was significantly lower in the group that received methotrexate plus prednisone vs. the group that had methotrexate plus placebo: 0 (range 0–0) vs. 0 (0–2), p=0.002 in a non-parametric test based on ranks.
No significant differences were seen between the groups in steroid-related side effects.
Summing up, Dr. Safy tells Reuters Health by email that the prednisone-methotrexate-based treatment “is an effective cost-saving strategy” in early RA that may delay or even prevent initiation of a more expensive biological DMARD.
Dr. Dennis Ang, section chief, rheumatology and immunology at Wake Forest Baptist Medical Center in Winston-Salem, North Carolina, tells Reuters Health, “Historically, long term glucocorticoid (e.g., prednisone) use is fraught with a whole range of adverse side effects.”
“Thus,” he says by email, “clinicians are appropriately hesitant in prescribing the medication to patients with RA.”
“In the current paper, it is reassuring to note that the addition of 10 mg prednisone daily to methotrexate in early RA results in lower initiation rate of a first biologic agent, without the associated side effects from glucocorticoids,” he says.
“However,” he adds, “two important caveats have to be mentioned. First, the study findings can also be explained by other treatments—known and unknown—during the post-trial follow-up and not necessarily from prednisone. Second, although better radiographic outcomes were seen with the use of prednisone, we do not know whether patients were actually doing better in the absence of disease-specific quality of life measure.”
References
- Safy M, Jacobs J, IJff ND, et al. Long-term outcome is better when a methotrexate-based treatment strategy is combined with 10 mg prednisone daily: Follow-up after the second Computer-Assisted Management in Early Rheumatoid Arthritis trial. Ann Rheum Dis. 2017 Apr 27. pii: annrheumdis-2016-210647. doi: 10.1136/annrheumdis-2016-210647. [Epub ahead of print]
- Bakker MF, Jacobs JW, Welsing PM, et al. Low-dose prednisone inclusion in a methotrexate-based, tight control strategy for early rheumatoid arthritis: A randomized trial. Ann Intern Med. 2012 Mar 6;156(5):329-39. doi: 10.7326/0003-4819-156-5-201203060-00004.
