Data presented today at the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology showed that patients with ankylosing spondylitis (AS) who received REMICADE? (infliximab) over two years experienced significant improvement in spinal mobility.
In addition, REMICADE-treated patients showed sustained reductions in spinal inflammation through two years as detected by magnetic resonance imaging (MRI).
The recommended dose of REMICADE in AS is 5 mg/kg given as an IV induction regimen at 0, 2 and 6 weeks followed by a 5 mg/kg maintenance regimen every 6 weeks in the United States or every 6-8 weeks in the European Union. AS is a progressive rheumatic disease that leads to inflammation of the back, resulting in pain, stiffness and reduced mobility, which in advanced cases can result in fusion of the vertebrae of the spine (‘ankylosis’). Data collected from 279 patients with AS as part of the Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy (ASSERT) trial were analyzed to determine the long-term effect of REMICADE on spinal mobility. The double-blind extension of this 24-week placebo-controlled study utilized the Bath Ankylosing Spondylitis Metrology Index (BASMI) and chest expansion measurements to assess range of motion in patients with AS.
Patients in ASSERT were treated and assessed at six week intervals through week 102. According to the findings, compared with placebo group (N=78), at week 24 the REMICADE-treated patients (N=201) had a greater improvement in BASMI (defined as a change of at least 1 in the BASMI score) scores (-0.7 vs. -0.2, respectively; P = 0.02), and in percent change in chest expansion (44 percent vs. 19 percent, respectively, P = 0.03). Fifty-one percent of REMICADE-treated patients vs. 31 percent of placebo-treated patients achieved a clinically meaningful improvement in BASMI (P < 0.01). The improvement seen at week 24 was maintained through week 102 in those patients who continued in the trial extension (N=161). Furthermore, after crossing over to receive treatment with REMICADE at week 24 following initial treatment with placebo, patients experienced similar improvements in BASMI and chest expansion scores as patients in the REMICADE group at weeks 54, 78 and 102.?Ankylosing spondylitis can limit spinal mobility and significantly impair a patient?s quality of life. These data demonstrate that treatment with REMICADE improved spinal mobility. Over time, this improvement can be maintained when REMICADE is coupled with physiotherapy,? said Professor Jurgen Braun, M.D., lead physician at the Rheumazentrum Ruhrgebiet and Professor of Rheumatology at the Free University of Berlin. ?In studying the same group of patients, REMICADE therapy also had a positive effect on spinal inflammation, a common and debilitating manifestation of ankylosing spondylitis.?In ASSERT spinal inflammation as detected by MRI was examined. Patients receiving REMICADE showed improvement in MRI Activity scores at week 24, which was sustained through week 102 in those patients who continued in the trial extension (N=161). Patients initially in the placebo group showed no change in MRI Activity scores at week 24, but scores improved after crossing over to receive treatment with REMICADE. The relationship of spinal inflammation as measured by activity scores on MRI to long-term structural damage in AS is unknown.