乌鸦传媒

High remission rates were observed for all treatment regimens at 6 months in a trial involving very early rheumatoid arthritis (RA) known as NORD-STAR, a researcher reported during an oral abstract presentation at the

Among patients receiving active conventional therapy, which was methotrexate plus quickly tapered oral prednisolone or methotrexate plus sulfasalazine, hydroxychloroquine, and intra-articular glucocorticoid injections in swollen joints, remission at 24 weeks according to the Clinical Disease Activity Index (CDAI) was achieved by 42% of patients, said Merete L. Hetland, MD, PhD, of the University of Copenhagen in Denmark.

Among patients who received methotrexate plus a biologic, the following remission rates were observed:

• Abatacept (Orencia), 52.5%

• Certolizumab pegol (Cimzia), 47.8%

• Tocilizumab (Actemra), 41%

The differences from the conventional therapy arm were 9% (95% CI 0.1-19%) for the abatacept arm, 4% (95% CI -5 to 13%) for the certolizumab arm, and -1% (95% CI -10 to 9%) for the tocilizumab arm, Hetland reported. Only the abatacept arm differed significantly from the conventional therapy (reference) arm, she noted.

NORD-STAR is a multicenter randomized study conducted in Sweden, Norway, Finland, the Netherlands, Denmark, and Iceland that is intended to provide data on the efficacy of very early treatment of RA. Participants had not been previously treated, had Disease Activity Scores in 28 joints (DAS28) above 3.2, and were positive for rheumatoid factor (RF) or anti-citrullinated protein antibodies (ACPA) or had C-reactive protein levels above 10 mg/L. Patients also were required to have at least two swollen and tender joints.

Participants' mean age was 54, two-thirds were women, and mean body mass index (BMI) was 26.2. About 82% were ACPA positive and 74.9% were RF positive. Baseline CDAI was 28.6 and baseline DAS28 was 5. Mean disease duration was 7 days.

Patients in all groups received methotrexate in dosages of 25 mg/week after the first month.

"At week 24, CDAI remission rates exceeded 40% in all treatment groups," Hetland said.

On key secondary outcomes, there were no significant differences between the conventional therapy group and any of the biologic groups. For instance, remission rates according to the DAS28 were 63.5% in the conventional therapy group, 68.5% in the certolizumab group, 69.6% in the abatacept group, and 63.3% in the tocilizumab group. Similarly on the simplified disease activity index, remission was achieved by 41.5% of the conventional therapy arm and by 49.8%, 51.5%, and 42.6% of the certolizumab, abatacept, and tocilizumab groups, respectively.

On a noninferiority analysis that adjusted for age, sex, ACPA status, country, BMI, and baseline DAS28 and which had a predefined 15% margin, the active conventional treatment was noninferior to certolizumab and tocilizumab, but not to abatacept.

"These findings underscore the efficacy of active conventional therapy based on methotrexate combined with glucocorticoids and may help guide future treatment strategies for early RA," Hetland concluded.