Newswise — The use of prednisone therapy, especially in high doses, increases the odds that a person with rheumatoid arthritis will develop an infection, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in Philadelphia, Pa.
Rheumatoid arthritis is a chronic disease that causes pain, stiffness, swelling, and limitation in the motion and function of multiple joints. Though joints are the principal body parts affected by RA, inflammation can develop in other organs as well. An estimated 1.3 million Americans have RA, and the disease typically affects women twice as often as men.
Researchers recently compared the use of different combinations of immunosuppressive RA therapies, specifically TNF inhibitors and conventional disease-modifying antirheumatic drugs (commonly called DMARDs) such as methotrexate, leflunomide hydroxychloroquine or sulfasalazine, TNF–inhibitors (i.e., infliximab, etanercept, or adalimumab) and corticosteroids, including prednisone, to the risk of infection in people with RA.
Researchers used both the VA National Patient Care Database and the Pharmacy Benefits Management Database to identify cases of RA from October 1, 2000 through September 30, 2007. By definition, patients with RA had had two outpatient visits at least 30 days apart or one inpatient visit, and had had at least one prescription for a DMARD. They determined that approximately 35 percent of patients are on prednisone, which is mostly used in those whose RA is difficult to control with DMARDS or TNF inhibitors alone.
The researchers examined 3,457 cases of RA patients with a serious infection (i.e., requiring hospitalization) as well as patients with RA who had not experienced a serious infection. The study showed that the use of any prednisone, especially in high doses, was associated with increased odds of infection in RA when added to an anti-TNF or DMARD, from either of two groups: methotrexate/leflunomide and sulfasalazine/hydroxychloroquine.
The risk of serious infection with a TNF- inhibitor alone was similar to that of a DMARD when combined with a low dose of prednisone. The combination of a TNF–inhibitor, two or more DMARDs, and any dosage of prednisone was associated with the highest odds of serious infection. The presence of other conditions and/or anemia also increased the risk of infection.
“Although drugs such as corticosteroids or TNF inhibitors may increase the risk of infection, they are often necessary to control RA,” explains Eduardo Bonilla Trejos, MD; staff physician, Pittsburgh VA Healthcare, Pittsburgh, Pa., and lead investigator in the study. “The important message is that if a patient with RA requires a combination of a TNF–inhibitor, DMARDs and corticosteroids to manage their disease, both patients and their rheumatologists should be particularly vigilant to the possibility of infection, especially in the presence of comorbid conditions and/or anemia.”
Patients should talk to their rheumatologists to determine their best course of treatment
The ACR is an organization of and for physicians, health professionals, and scientists that advances rheumatology through programs of education, research, advocacy and practice support that foster excellence in the care of people with or at risk for arthritis and rheumatic and musculoskeletal diseases. For more information on the ACR’s annual meeting, see www.rheumatology.org/annual.
Editor’s Notes: Dr. Bonilla Trejos will present this research during the ACR Annual Scientific Meeting at the Pennsylvania Convention Center at 11:15 AM on Wednesday, October 21 in Room 108 B. Dr. Bonilla Trejos will be available for media questions and briefing at 8:30 AM on Sunday, October 18 in the on-site press conference room, 109 A.
Presentation Number: 2058
Risk of Infection in Rheumatoid Arthritis Associated with Use of Anti-TNF Agents, Dmards and/or Prednisone
Eduardo Bonilla Trejos, MD, Pittsburgh VA Healthcare System, Pittsburgh, Pittsburgh, PA Michael J. Hannon, MA, University of Pittsburgh, Pittsburgh, PA Melissa Skanderson, MA, Pittsburgh VA Healthcare System, Pittsburgh, Pittsburgh, PA Chester Good, MD, Pittsburgh VA Healthcare System, Pittsburgh, Pittsburgh, PA C. Kent Kwoh, MD, Rheum & Clinical Immunology, University of Pittsburgh, Pittsburgh, PA
Purpose: To compare the risk of infection associated with different treatment options for RA taking into account the potential combinations of DMARDs, anti-TNF agents and corticosteroids
Method: Data from both the VA National Patient Care Database and the Pharmacy Benefits Management Database dating from Oct. 1, 2000 to Sept. 30, 2007 were utilized to identify cases of RA. The definition of RA was based on ICD-9 codes 714* (either two outpatient codes at least 30 days apart or one inpatient code) and having ever had at least one prescription for a DMARD. A nested case-control study design was utilized to examine 3457 cases of RA patients with a serious infection that were identified based on their corresponding ICD-9 codes from an inpatient admission. Controls with RA but without a serious infection were matched 2:1 by year of initial RA visit, an inpatient or outpatient visit in the same month and year as the inpatient visit for RA case, and location in the same VA region (VISN). Conditional logistic regression was used to examine the risk of serious infection based on DMARD exposure in the 100 days prior to the inpatient admission while controlling for age, gender and the Deyo modification of the Charlson Comorbidity score. The exposures were DMARD1 (i.e., methotrexate/leuflonomide), DMARD2 (i.e., sulfasalazine/hydroxychloroquine/azathiprine), TNF (i.e., infliximab/etanerecept/adalimumab) and Prednisone equivalents (PRED, i.e., categorized as none, low dose (mean of 1-10mg/day) or high dose (mean of >10mg/day)). The reference group consisted of RA patients not on any TNF, DMARDs or PRED.
Results: The results are summarized in the table below. (view press release with full abstract at www.rheumatology.org.)
Conclusion: The use of any PRED, especially high dose PRED, is associated with an increased odds of infection in RA when added to a TNF or DMARD. The risk of serious infection with TNF alone is similar to that of DMARD1 or DMARD2 combined with low dose PRED. The combination of TNF, any DMARD and any PRED is associated with the highest odds of serious infection and should be used with special caution.
Disclosure: E. Bonilla Trejos, None; M. J. Hannon, None; M. Skanderson, None; C. Good, None; C. K. Kwoh, Abbott Immunology Pharmaceuticals, 5, Centocor, Inc., 5, Wyeth Pharmaceuticals, 5, Centocor, Inc., 2.
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