Abstract Number: PB0508
Meeting: ISTH 2021 Congress
Theme: Hemophilia and Rare Bleeding Disorders » Hemophilia - Clinical
Background: Joint damage in patients with hemophilia (PWH) may require surgical intervention. However, surgery effects on bleeding rates are unclear.
Aims: To investigate the effect of joint surgery on clinical outcomes (joint bleeding rates and patient-reported outcomes [PROs]), in PWH A on prophylaxis with turoctocog alfa pegol (N8-GP).
Methods: Patients in the Pathfinder 2 clinical study received N8-GP prophylaxis and enrolled in the Pathfinder 3 study for their surgeries. Patients returned to Pathfinder 2 post-surgery and continued prophylaxis until end-of-study. Pre-surgery (immediately before surgery) and post-surgery (at Pathfinder 2 end-of-study) joint annualized bleeding rates (jABRs) were calculated collectively across all reported joint locations. Joint-health-related PROs were derived from patient records.
Results: Data from 41 joint surgeries in 30 patients were analyzed using a datamining approach and descriptive analysis. Pre-surgery mean jABR was similar in the surgery patients vs 146 non-surgery patients. In surgery patients, mean jABR decreased pre-surgery to post-surgery (1.33 to 0.37, p=0.03). In all but three patients, jABR improved or remained the same post-surgery (Table 1).
| Table 1: Numbers of patients and surgeries in each jABR outcome group | |||||
|---|---|---|---|---|---|
| Post-surgery vs pre-surgery jABR | Total | ||||
| Improved | Remained at 0 | Remained at 1 | Worsened* | ||
| Number of patients† | 13 | 13 | 3 | 3 | 30 |
| Number of surgeries | 17 | 18 | 3 | 3 | 41 |
| *Of the three patients whose jABR worsened, all had longstanding arthropathy, and two underwent surgery for implant pain and bilateral trigger thumbs, respectively. †Two patients were counted twice because of multiple surgeries with different effects on jABR. jABR, joint annualized bleed rate. |
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Numbers of patients and surgeries in each jABR outcome group
In the three patients whose jABR was stable at 1 (all with multiple joint arthropathy), post-surgery bleeds were mostly at non-operated sites. Two of the three patients whose jABR increased underwent surgery for prosthetic pain and bilateral trigger thumbs, resolution of which may not ameliorate overall longstanding arthropathy. Mobility parameters often improved in patients whose jABR was 0 pre-surgery and post-surgery (Table 2).
| Table 2: Effect of surgery on PRO scores in patients whose jABR was 0 before and after surgery (13 patients; 18 surgeries) | |||||
|---|---|---|---|---|---|
| PRO parameter | Count of surgeries | ||||
| Parameter improved | Parameter remained the same |
Parameter worsened | Not collected | Total | |
| Pain in joints | 6 | 9 | 2 | 1 | 18 |
| Painful to move | 13 | 1 | 4 | – | 18 |
| Difficulty to walk as far as wanted | 10 | 4 | 4 | – | 18 |
| Joint-health-related PROs were based on responses to the Haem-A-QoL AU1.0 questionnaire before and after surgery. The questionnaire reported whether patients had experienced the outcomes in the preceding 4 weeks. Haem-A-QoL, Haemophilia Quality of Life Questionnaire for Adults; PRO, patient-reported outcome. |
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Effect of surgery on PRO scores in patients whose jABR was 0 before and after surgery (13 patients; 18 surgeries)
Conclusions: Combined analysis of Pathfinder 2 and 3 permitted assessment of joint bleeding and PROs after joint surgery. Mean jABR significantly declined post-surgery and mobility parameters improved in patients whose pre- and post-surgery jABR was 0. However, these findings should be interpreted with caution. A general decline in jABR was observed in the pathfinder 2 cohort, whose patients were on N8-GP prophylaxis; effects in patients after surgery cannot be attributable solely to surgery.
To cite this abstract in AMA style:
Tiede A, Shivamurthy S, Chowdary P. Clinical Outcomes after Joint Surgery in Patients on Turoctocog Alfa Pegol Prophylaxis [abstract]. Res Pract Thromb Haemost. 2021; 5 (Suppl 2). https://abstracts.isth.org/abstract/clinical-outcomes-after-joint-surgery-in-patients-on-turoctocog-alfa-pegol-prophylaxis/. Accessed January 26, 2022.« Back to ISTH 2021 Congress
ISTH Congress Abstracts - https://abstracts.isth.org/abstract/clinical-outcomes-after-joint-surgery-in-patients-on-turoctocog-alfa-pegol-prophylaxis/