medwireNews: Initiating the tumor necrosis factor (TNF) inhibitor golimumab at the same time as methotrexate almost doubles the rate of remission versus methotrexate monotherapy in patients with early psoriatic arthritis (PsA), study findings indicate.
Dominique Baeten (University of Amsterdam, the Netherlands) and colleagues say that, combined with the good tolerability and absence of novel safety signals, their results highlight “the value of early intervention in PsA rather than the classical step-up approach.”
After 22 weeks of treatment, 81% of the 26 patients randomly assigned to receive subcutaneous golimumab (50 mg monthly) plus methotrexate (15 mg/week starting dose, increasing to 25 mg/week over 8 weeks) achieved remission, defined as a disease activity score based on C-reactive protein of less than 1.6 points.
The rate among the 24 patients who received placebo plus methotrexate was 42%, giving a significant difference between the groups. None of the patients included in the study had previously received either methotrexate or a biologic DMARD.
In addition, patients who received golimumab had a significantly higher rate of low disease activity according to Disease Activity in Psoriatic Arthritis criteria (92 vs 54%) and were more likely to reach minimal disease activity (81 vs 29%) than patients who did not receive golimumab.
Patients in the golimumab group were also more likely to achieve an ACR20, 50, or 70 response than those in the placebo group (85 vs 58%, 81 vs 33%, and 58 vs 13%, respectively).
The researchers note that the difference for each of these outcomes was already statistically significant by week 8 and was often more pronounced by week 22.
However, they say that it is currently “unknown if the responses – in particular the stringent responses such as remission – have already plateaued at week 22 or could even further increase over time.”
They add that an extension study among patients maintained on methotrexate monotherapy for up to week 50 will help to determine whether the combination of golimumab and methotrexate “is only needed for the induction of remission or is also needed to maintain this state of remission over time.”
Writing in the Annals of the Rheumatic Diseases, Baeten and co-authors note that although they used golimumab as their TNF inhibitor, “there is no scientific or clinical evidence suggesting that the concept demonstrated here would not apply to all TNF [inhibitors].”
They continue: “Whether the concept also applies to other biologic targeted therapies used in PsA (anti-IL-17A, anti-p40, anti-p19) remains to be investigated.”
The researchers conclude that their findings extend “the results of the open-label RESPOND study [and show] that early initiation of TNF [inhibitors] contributes to achieve low disease activity or even remission in PsA.”
By Laura Cowen
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