Clinical outcomes after joint surgery in patients on turoctocog alfa pegol (N8-GP) prophylaxis: A post hoc analysis.

INTRODUCTION: Joint damage in haemophilia often requires surgical correction. However, the surgery effect on bleeding rates and other clinical joint outcomes can be unclear.

AIM: To investigate the effects of joint surgery on joint annualized bleeding rates (JABRs) and physical health outcomes in patients with haemophilia A undergoing N8-GP prophylaxis.

METHODS: Patients in the pathfinder 2 trial received N8-GP prophylaxis, enrolling in the pathfinder 3 trial for indicated surgery. Patients returned to pathfinder two post-surgery, continuing N8-GP prophylaxis until end-of-trial. JABRs were calculated from bleeding across all joints for pre-surgery (immediately before surgery) and post-surgery (to pathfinder 2 study end) periods. Joint-health-related outcomes were derived from patient records.

RESULTS: Data (41 joint surgeries; n = 30) were analysed statistically using datamining and descriptively. Pre-surgery mean JABR was higher in patients who later were operated than in 146 non-operated patients (p = .004). In operated patients, mean JABR decreased from 1.33 pre-surgery to .37 post-surgery (p = .011). In all but three patients, JABR improved or remained the same post-surgery. In the three patients whose JABR remained at one (all with multiple joint arthropathy), post-surgery bleeds were mostly at non-operated sites. Two of the three patients whose JABR increased post-surgery had undergone surgery for reasons unlikely to improve JABR. Mobility parameters often improved in patients whose JABR remained at zero.

CONCLUSION: Patients with haemophilia treated with N8-GP prophylaxis benefit from surgeries. However, this analysis could not differentiate the relative contributions of surgical interventions and prophylactic treatment to the improvement of JABR.