medwireNews: A 23-year follow-up analysis of the COBRA study has shown a normalization of mortality in patients with rheumatoid arthritis (RA), supporting the benefits of early, intensive treatment.
The COBRA (COmbinatietherapie Bij Rheumatoide Artritis) study was conducted from 1993 to 1995 and involved 76 patients (COBRA cohort) who were treated with high, step-down prednisolone (60 mg/day in week 1, rapidly tapered to 7.5 mg/day within 7 weeks), methotrexate (at 7.5 mg/week for 42 weeks), and sulfasalazine (2000 mg/day for 56 weeks) and 70 who received sulfasalazine monotherapy.
In an 11-year follow-up analysis the COBRA cohort was found to have numerically lower mortality, better disease control, and a similar safety profile, compared with the sulfasalazine group.
Further follow-up now shows that these patients with RA, irrespective of treatment, had a numerically but not significantly lower mortality after 23 years than a reference general population.
Presenting the data at the EULAR 2018 meeting in Amsterdam, the Netherlands, Pomme Poppelaars (VU University Medical Center, Amsterdam) reported that 44 (28%) out of 154 of the RA patients died, compared with 55 (35%) out of 154 of the general population, giving a nonsignificant standardized mortality ratio of 0.80.
There was no significant difference in the mortality rates between the 74 patients in the COBRA treatment group and the 79 of those taking sulfasalazine monotherapy, at 27% and 30%, respectively, with corresponding standardized mortality ratios of 0.75 and 0.85 relative to the general population.
The survival curve for the COBRA cohort remained consistently above that for the general population for the duration of the 23 years, Poppelaars noted. The curve for the sulfasalazine treatment group was below that for the general population, but for the last 3 years was also above.
Poppelaars pointed out the long and almost full follow-up of the study, but she acknowledged that the sample size was relatively small and suggested caution over the generalizability of the findings to a “normal” RA population given that the patients in the COBRA trial had a poor prognosis and less comorbidity.
She concluded: “We show a normal mortality in a trial inception cohort of patients with RA treated early with either COBRA therapy or sulfasalazine monotherapy.
“We are the first study with more than 20 years [of follow-up] to show this.”
By Lucy Piper
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