Clinical efficacy, radiographic and safety findings through 2 years of golimumab treatment in patients with active psoriatic arthritis: results from a long-term extension of the randomised, placebo-controlled GO-REVEAL study

Abstract

Objectives: To assess long-term golimumab efficacy/safety in patients with active psoriatic arthritis (PsA).

Methods: Adult PsA patients (≥3 swollen, ≥3 tender joints, active psoriasis) were randomly assigned to subcutaneous injections of placebo, golimumab 50 mg or 100 mg every 4 weeks (q4wks) through week 20. All patients received golimumab 50 or 100 mg beginning week 24. Findings through 2 years are reported. Efficacy evaluations included ≥20% improvement in American College of Rheumatology (ACR20) response, good/moderate response in Disease Activity Scores incorporating 28 joints and C-reactive protein (DAS28-CRP), ≥75% improvement in Psoriasis Area and Severity Index (PASI75) and changes in PsA-modified Sharp/van der Heijde scores (SHS).

Results: Golimumab treatment through 2 years was effective in maintaining clinical response (response rates: ACR20 63%-70%, DAS28-CRP 77%-86%, PASI75 56%-72%) and inhibiting radiographic progression (mean change in PsA-modified SHS in golimumab-treated patients: -0.36), with no clear difference between doses. No new safety signals were identified through 2 years. With the study's tuberculosis screening and prophylactic measures, no patient developed active tuberculosis through 2 years.

Conclusions: Golimumab 50 and 100 mg for up to 2 years yielded sustained clinical and radiographic efficacy when administered to patients with active PsA. Increasing the golimumab dose from 50 to 100 mg q4wks added limited benefit. Golimumab safety through up to 2 years was consistent with other antitumour necrosis factor α agents used to treat PsA. Treatment of patients with latent tuberculosis identified at baseline appeared to be effective in inhibiting the development of active tuberculosis.

Keywords: Anti-TNF; Psoriatic Arthritis; Spondyloarthritis.

Figure 1

The proportions of patients achieving clinical improvement, defined by at least 20%, 50% and/or 70% improvement in the American College of Rheumatology (ACR20, ACR50, and ACR70, respectively) response criteria ((A) all patients, (B) patients with methotrexate (MTX) use at baseline, (C) patients with no MTX use at baseline) or at least 50%, 75% and/or 90% improvement in the Psoriasis Area and Severity Index (PASI50, PASI75 and PASI90, respectively) response criteria among randomised patients with baseline psoriasis involving ≥3% body surface area ((D) all patients, (E) patients with MTX use at baseline, (F) patients with no MTX use at baseline). Patients were assessed according to randomised treatment group using an intent-to-treat analysis and missing data imputation rules were applied. Placebo patients include all patients randomised to the placebo arm, including those who early escaped at week 16 or crossed over at week 24 to receive golimumab 50 mg or dose escalated after the week-52 database lock to receive golimumab 100 mg. Patients in the golimumab 50-mg group include all patients who were randomised to the golimumab 50-mg arm including those patients who early escaped at week 16 or dose escalated after the week-52 database lock to receive golimumab 100 mg. Patients in the golimumab 100-mg group include all patients randomised to the golimumab 100-mg arm; these patients had no change in study treatment through week 104.

Figure 2

Psoriatic arthritis (PsA)-modified Sharp/van der Heijde score (SHS). (A–C) Changes from baseline in the total PsA-modified SHS at week 104 by randomised treatment group and baseline methotrexate (MTX) use. (A) All patients, (B) patients receiving MTX at baseline and (C) patients not receiving MTX at baseline. Figures include patients who had a total modified SHS at baseline and after week 52. Means are represented by solid lines, medians by dotted lines and IQRs by bars. Missing data rules were applied. (D–F) Empirical cumulative distribution function of change from baseline in total PsA-modified SHS at week 104 by randomised group and baseline MTX use. (D) All patients, (E) patients receiving MTX at baseline and (F) patients not receiving MTX at baseline. The cumulative distribution function plots include patients who had scores at baseline and after week 52. No missing data imputation was applied (ie, plots exclude two, three and three patients in the placebo, golimumab 50-mg and golimumab 100-mg groups, respectively, who were included in the analysis of change from baseline to week 104 in figure 2A–C). All panels: placebo patients include all patients randomised to the placebo arm, including those who early escaped at week 16 or crossed over at week 24 to receive golimumab 50 mg or dose escalated after the week-52 database lock to receive golimumab 100 mg. Patients in the golimumab 50-mg group include all patients who were randomised to the golimumab 50-mg arm including those who early escaped at week 16 or dose escalated after the week-52 database lock to receive golimumab 100 mg. Patients in the golimumab 100-mg group include all patients randomised to the golimumab 100-mg arm; these patients had no change in study treatment through week 104.