Dr. Norman B. Gaylis
Objectives: To evaluate corticosteroid use in patients with refractory rheumatoid arthritis (RA) after initiation of infliximab therapy.
Methods: We conducted a retrospective evaluation of 70 patients (5 male, 65 female) in our community rheumatology practice. All patients met the following inclusion criteria: diagnosis of RA consistent with American College of Rheumatology criteria, initiation of infliximab infusions as a result of unchanged or worsening symptoms despite treatment with standard therapy, and administration of a minimum of 4 infliximab infusions.
Standard therapy was defined as treatment with prednisone plus either methotrexate, nonsteroidal anti-inflammatories, or both. Infliximab was administered to all patients at a starting dose of 3 mg/kg and subsequently maintained or increased based upon clinical response. All patients received initial infusions in our office at 0, 2 and 6 weeks and then maintenance infusions every 8 weeks or as needed. For each patient the following parameters were evaluated: daily prednisone dose before infliximab infusions, daily prednisone dose 18 months after initiation of infliximab infusions, and infliximab dosing.
Results: At baseline, the average daily prednisone requirement was 7.5 mg (range, 2.5 mg to 20 mg). The average infliximab dose during the first 18 months of treatment was 4.5 mg/kg (range, 3 to 8 mg/kg). After 18 months of infliximab treatment, 29 patients (41%) were able to completely discontinue prednisone therapy. Twenty-nine additional patients (41%) achieved a reduction in daily prednisone use. Twelve patients (17%) continued on the same prednisone dose as compared to baseline.
Conclusion: Our review demonstrated that infliximab was effective in reducing signs and symptoms of RA in patients requiring corticosteroid therapy to maintain adequate levels of function and comfort. This improved response following infliximab therapy permitted the safe reduction or discontinuation of corticosteroids in the majority patients. The ability to discontinue or reduce daily prednisone doses decreases the development of long-term adverse effects caused by corticosteroid therapy. In addition, it provides an important measurement of clinical response. Although decreased corticosteroid use has not traditionally been an outcome measure in RA patients, our review demonstrates this endpoint was significant in the majority of patients. In addition to other standard measures, changes in corticosteroids use following biologic therapy should be viewed as a key measure of clinical outcome in patients with RA.
Click here to access the Abstract presented at the European League Against Rheumatism in June 2004.