FX006 met its primary endpoint at Week 12, demonstrating significant (P<0.0001), durable and clinically meaningful pain relief vs. placebo in patients (n=486) with moderate to severe knee osteoarthritis pain. Additionally, FX006 demonstrated statistically significant analgesia compared with placebo at Weeks 1–16, with active drug-treated patients obtaining an average of 50% pain reduction from baseline over Weeks 1–12. Additionally, FX006 achieved statistical significance on WOMAC A, B and C (pain, stiffness and function) through Week 12 compared with placebo and immediate-release TCA.
A New Drug Application submission is planned for the second half of this year.
Golimumab Improves Radiographic Progression
A recently published study in Arthritis Care & Research outlined the long-term outcomes of patients who did and did not achieve minimal disease activity during the GO-REVEAL trial.5 These patients (n=405) had psoriatic arthritis (PsA) and participated in the trial for up to five years.
The GO-REVEAL trial was a Phase 3 randomized, double-blind, placebo-controlled trial of golimumab for 24 weeks. After Week 24, patients received an open-label extension of subcutaneous golimumab injections of either 50 or 100 mg given once every four weeks for up to five years. Patients were allowed to continue their stable methotrexate dose. By Week 16, if there was less than a 10% improvement in a patient’s swollen and tender joint count, the patient dose was increased. Placebo-treated patients were increased to 50 mg golimumab every four weeks, and patients treated with 50 mg golimumab were increased to 100 mg golimumab every four weeks.
Of the 405 patients, 126 (31%) discontinued the study treatment by Week 252, mostly due to adverse events and disappointing therapeutic response. Patients who received golimumab vs. placebo at Week 14 (P<0.0001; 24% compared with 1%) and Week 24 (P<0.0001; 28% compared with 8%) had a significantly greater minimal disease activity attainment and a greater response. Baseline methotrexate use did not change these results. The Week 52 response was 42%, compared with 30% for placebo.
Overall, minimal disease activity was realized at least once by about half of golimumab-treated patients. No matter what treatment patients were initially randomized to receive, those patients who showed more improvement in at least three or four consecutive time points had significantly less radiographic progression and greater functional outcomes at five years compared with those who did not meet minimal disease activity criteria. These outcomes did not necessarily correlate with changes in skin involvement.
In this study, 50 or 100 mg subcutaneous golimumab every four weeks led to better long-term functional improvement, better radiographic outcomes and better patient global assessment in patients who attained persistent minimal disease activity.