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.