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18-07-2019 | Rheumatoid arthritis | News

Surrogate randomization technique enables triple biologic comparison

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medwireNews: Estimated remission and retention rates do not differ significantly among patients with rheumatoid arthritis (RA) treated with either certolizumab pegol, abatacept, or biosimilar infliximab (CT‐P13), show the results of a surrogate randomized controlled trial (RCT).

Kathrine Grøn (Rigshospitalet, Copenhagen, Denmark) and colleagues explain that in Denmark, “nationwide guidelines on mandatory choice of biologic DMARD are issued approximately annually based on a combination of expert opinion and costs.”

They hypothesized that “the guidelines could be perceived as a surrogate randomization tool and that choice of [biologic] DMARD would be determined by calendar period rather than by patient-specific factors, thus minimizing confounding by indication.”

“This might provide a unique opportunity for emulating an RCT thus enabling the comparison of real-world effectiveness of three drugs that have never been compared directly in the same RCT,” the researchers add.

The three drugs – certolizumab pegol, abatacept, and CT-P13 – were the mandatory treatment choice in 2013–2014, 2014–2015, and 2015–2016, respectively.

Using the nationwide DANBIO registry of patients with inflammatory arthritis, Grøn and team identified 776 biologic-naïve patients with RA who began guideline-recommended biologic treatment in combination with methotrexate between 2013 and 2016.

Baseline characteristics, including disease activity, were generally similar across the three groups and the researchers note that adherence to guidelines during each period was high, at 70%, 65%, and 59% when certolizumab pegol, abatacept, and CT-P13 were the recommended drugs, respectively.

The researchers report in Arthritis & Rheumatology that, at 6 months, the DAS28 remission rates (score <2.6) were 35% among the 336 patients who received certolizumab pegol, 33% among the 215 who received abatacept, and 42% among the 225 who received CT-P13. The corresponding rates at 12 months were 35%, 31%, and 35%.

After adjustment for age, sex, DAS28, HAQ, smoking status, and comorbidity, there was no significant difference among the three groups in either DAS28 remission at 6 and 12 months, or in the risk for withdrawal during the first year of treatment.

Grøn et al conclude that they “showed how a surrogate randomization procedure (calendar year), enabled direct comparison of the effectiveness of certolizumab pegol, abatacept and CT-P13.”

They continue: “Although some differences in the estimated remission and retention rates across the three drugs were observed, the confidence intervals were wide, and no statistically significant differences were found.”

By Laura Cowen

medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group

Arthritis Rheumatol 2019; doi:10.1002/art.41031

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