In the Long Run, Golimumab Reduces Disease Activity in PsA

Mar 26, 2015

Over five years, in the randomized GO-REVEAL study, golimumab helped more than half of psoriatic arthritis patients achieve minimal disease activity.

Kavanaugh A, van der Heijde D, Beutler A, et al., Patients with psoriatic arthritis who achieve minimal disease activity in response to golimumab therapy demonstrate less radiographic progression: Results through 5 years of the randomized, placebo-controlled, GO-REVEAL study.Arthritis Care & Research. Accepted article. doi: 10.1002/acr.22576. Online March 16, 2015.

Over five years, golimumab (Simponi) produces minimal disease activity (MDA) in around half of psoriatic arthritis (PsA) patients – along with less radiographic progression and better function, according to post-hoc analysis of a major clinical trial.

Data for 395 patients in the open-label extension of the GO-REVEAL trial also shows that delaying active treatment for 4 to 6 months may result in twice as much radiographic progression at 5 years. However, overall progression is still less.

Delaying treatment may also have affected skin improvement.

GO-REVEAL, a phase 3, randomized, double-blind trial, was placebo-controlled through 24 weeks with an open-label extension of golimumab 50 mg or 100 mg for up to 5 years.

MDA as a treat-to-target goal is defined in this trial -- meeting 6 or 7 of the following outcomes -- is more rigorous than typical endpoints in PsA studies:

•  1 (or no) swollen joints
•  1 or no tender joints
•  Psoriasis Area and Severity Index (PASI) 1 or less
•  Patient pain score 15 or below
•  Patient global disease activity (PtGA) score 20 or below
•  Health Assessment Questionnaire-Disability Index (HAQ-DI) 0.5 or below
•  1 (or no) tender enthesis points

Randomization initially made a difference. MDA progressively increased among golimumab patients versus the initial placebo group at weeks 14, 24, and 52.  (Percentages with MDA appear in the chart below.)

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However, if they reached MDA at 3 or 4 consecutive visits, representing 38 and 90 weeks, patients had more improvement in outcomes and less radiographic progression regardless of randomization.

Patients judged solely on achieving MDA based on 6 or 7 of the components above showed a similar pattern of more improvement and less progression, especially with longer treatment duration.What did make a difference was methotrexate (MTX) use at baseline: Radiographic benefits are more pronounced in MTX users.

Disclosures:

The GO-REVEAL study was funded by Jansen and Merk/Schering-Plough, developers of golimumab.

 

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