Sakshi Mittal1, G S R S N K Naidu1, Saket Jha1, Manish Rathi2, Ritambhra Nada3, Ranjana W Minz4, Kusum Sharma5, Varun Dhir1, Sanjay Jain1, Aman Sharma6. 1. Department of Internal Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, India. 2. Department of Nephrology, PGIMER,, Chandigarh, India. 3. Department of Histopathology, PGIMER, Chandigarh, India. 4. Department of Immunopathology, PGIMER, Chandigarh, India. 5. Department of Medical Microbiology, PGIMER, Chandigarh, India. 6. Department of Internal Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, India. amansharma74@yahoo.com.
Abstract
OBJECTIVES: To present single centre experience on the efficacy and safety of similar biologic of rituximab in patients with granulomatosis with polyangiitis (GPA). METHODS: This was a retrospective study of GPA patients who received similar biologic of rituximab as either remission induction or maintenance agent. Demographic parameters, Birmingham Vasculitis Activity Score (BVAS-v3), vasculitis damage index, relapse and adverse events were retrieved from patient records. Outcomes noted were remission at 6 months in remission induction group and rates of relapses, adverse events, serious infections and mortality in both remission induction and maintenance groups. RESULTS: Seventy-seven GPA patients were enrolled. Sixty received rituximab for induction and 57 for maintenance; 69% were anti PR-3 positive. In the induction group, median BVAS-v3 reduced from 12 (IQR 6-21.5) to 0 (0-1) at 6 months. At 6 months, 60% patients attained remission, 40% in primary induction group and 74% in re-induction group (p = 0.016%). In the maintenance group, seven (12%) patients had relapses with median time to relapse of 12 (6-22) months. Median relapse free survival was 21 (6-22) months on rituximab maintenance. There were 12 deaths (15.6%) and 18 serious infections. CONCLUSION: Similar biologic of rituximab was an effective agent for remission induction and remission maintenance in patients with GPA. Head to head trials with innovator molecule are needed to confirm these results. KEY POINTS: • Remission was achieved in 60% of GPA patients who received similar biologic of rituximab as remission induction therapy. • Relapse rate during maintenance phase was 12% with similar biologic of rituximab. Serious infections and mortality with similar biologic of rituximab were comparable with that reported previously in AAV trials.
OBJECTIVES: To present single centre experience on the efficacy and safety of similar biologic of rituximab in patients with granulomatosis with polyangiitis (GPA). METHODS: This was a retrospective study of GPA patients who received similar biologic of rituximab as either remission induction or maintenance agent. Demographic parameters, Birmingham Vasculitis Activity Score (BVAS-v3), vasculitis damage index, relapse and adverse events were retrieved from patient records. Outcomes noted were remission at 6 months in remission induction group and rates of relapses, adverse events, serious infections and mortality in both remission induction and maintenance groups. RESULTS: Seventy-seven GPA patients were enrolled. Sixty received rituximab for induction and 57 for maintenance; 69% were anti PR-3 positive. In the induction group, median BVAS-v3 reduced from 12 (IQR 6-21.5) to 0 (0-1) at 6 months. At 6 months, 60% patients attained remission, 40% in primary induction group and 74% in re-induction group (p = 0.016%). In the maintenance group, seven (12%) patients had relapses with median time to relapse of 12 (6-22) months. Median relapse free survival was 21 (6-22) months on rituximab maintenance. There were 12 deaths (15.6%) and 18 serious infections. CONCLUSION: Similar biologic of rituximab was an effective agent for remission induction and remission maintenance in patients with GPA. Head to head trials with innovator molecule are needed to confirm these results. KEY POINTS: • Remission was achieved in 60% of GPA patients who received similar biologic of rituximab as remission induction therapy. • Relapse rate during maintenance phase was 12% with similar biologic of rituximab. Serious infections and mortality with similar biologic of rituximab were comparable with that reported previously in AAV trials.
Entities:
Keywords:
ANCA-associated vasculitis; Biosimilar; Granulomatosis with polyangiitis; Rituximab; Similar biologic