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Patients with RA may benefit from Actemra in a combination or as monotherapy
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Actemra may improve symptoms for patients with rheumatoid arthritis when received either in combination with methotrexate or as monotherapy, according to the results of a study.
Researchers randomly assigned 1,162 patients with rheumatoid arthritis (RA) 1:1:1:1 to one of the following groups: 4 mg/kg Actemra (tocilizumab; Genentech) plus methotrexate; 8 mg/kg tocilizumab plus methotrexate; 8 mg/kg tocilizumab plus or placebo plus methotrexate. Overall, 920 patients completed the 52-week study.
Most of the patients had early RA with a mean duration of less than 0.5 years and little radiographic damage. Most of the patients had positive screens for rheumatoid factor and anti-cyclic, citrullinated peptides.
At week 24, remission was achieved in 45% of patients who received 8 mg/kg tocilizumab plus methotrexate compared with 15% of patients who received placebo plus methotrexate based on the mean Disease Activity Score using 28 joints (DAS28)-erythrocyte sedimentation rate (ESR). By week 52, 49% of patients who received 8 mg/kg tocilizumab plus methotrexate achieved remission compared to 20% of patients with RA in the placebo plus methotrexate group.
Mean DAS28-ESR scores decreased in all groups as the study continued, with the greatest decrease observed in the 8 mg/kg tocilizumab plus methotrexate group, which also demonstrated the most improved American College of Rheumatology (ACR) 20, ACR50 and ACR70 response rates at week 24 and week 52. Joint damage was more likely to be inhibited in patients who received 8 mg/kg tocilizumab plus methotrexate.
As many as 83% of patients who received any dose structure of tocilizumab had no radiographic progression from baseline at week 24 and week 52 compared with 73% of patients who received placebo plus methotrexate, and similar trends were observed with joint space narrowing. Mean Health Assessment Questionnaire – Disability Index scores were improved in patients who received either 4 mg/kg or 8 mg/kg tocilizumab plus methotrexate.
A similar number of adverse events were reported by all groups. Rates of study withdrawal were similar among the groups except methotrexate plus placebo. The most commonly reported reason for withdrawal was related to inadequate response in the placebo plus methotrexate group compared to adverse events cited by patients who withdrew from the tocilizumab groups with the highest number (20.3%) in the group of patients who received 8 mg/kg tocilizumab plus methotrexate. The events included elevated liver enzymes and infections, which occurred at a higher rate in patients who received 8 mg/kg tocilizumab plus methotrexate. Investigators found similar rates in the two 8 mg/kg groups, and the lowest rates among placebo plus methotrexate recipients. – by Shirley Pulawski
Disclosure s : Burmester reports grants paid to his institution from Roche and personal fees for lectures and consulting from AbbVie, Bristol-Myers Squibb, Merck Sharp & Dohme, Pfizer and UCB Pharma outside the submitted work. Please see the full study for a list of all other authors’ relevant financial disclosures.
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