Table 7.
Assessment of certainty of evidence using GRADE profiler
| Drug (reference number) | Outcomes evaluated (number of studies) | Certainty of evidence for outcome | Reason for downgrading certainty of evidence (if any) |
|---|---|---|---|
| Randomized controlled trials | |||
| Tocilizumab (72) | Relapses (1) | Moderate | Serious RoB |
| Angiographic stabilization (1) | Moderate | Serious RoB | |
| Reduction in prednisolone dose–median (1) | Moderate | Serious RoB | |
| Abatacept (63) | Relapses (1) | Moderate | Serious RoB |
| Duration of remission (1) | Moderate | Serious RoB | |
| Resveratrol (66) | Reduction in BVAS (1) | Very low | Very serious RoB, serious indirectness |
| Curcumin (65) | Reduction in BVAS (1) | Very low | Very serious RoB, serious indirectness |
| Observational studies with control arms* | |||
| Cyclophosphamide versus methotrexate (60, 67) | At least partial clinical response (2) | Very low | Serious RoB, serious imprecision |
| TNFi versus tocilizumab (55, 80) | At least partial clinical response (2) | Very low | Serious imprecision |
| bDMARDs versus cDMARDs (61, 69) | At least partial clinical response (2) | Low | - |
| Angiographic stabilization (2) | Low | - | |
| Uncontrolled observational studies* | |||
| Tocilizumab (46, 47, 49, 50, 51, 56, 59, 68, 70, 76, 77, 84, 85, 87, 91, 92, 95, 98) | At least partial clinical response (17) | Very low | Very serious RoB, serious inconsistency |
| Angiographic stabilization (12) | Very low | Very serious RoB, serious inconsistency | |
| Normalization of inflammatory markers (5) | Very low | Very serious RoB | |
| Relapses (4) | Very low | Very serious RoB, serious inconsistency | |
| Improvement on PET-CT (5) | Very low | Very serious RoB and inconsistency, serious imprecision | |
| Reduction in prednisolone dose–mean (8) | Very low | Very serious RoB, serious inconsistency | |
| Reduction in prednisolone dose–median (5) | Very low | Very serious RoB, serious inconsistency | |
| TNFi (36, 37, 40, 43, 44, 45, 48, 52, 54, 62, 73, 74, 79, 81, 88. 98) | At least partial clinical response (15) | Very low | Very serious RoB, serious inconsistency |
| Angiographic stabilization (10) | Very low | Very serious RoB, serious inconsistency | |
| Normalization of inflammatory markers (2) | Very low | Very serious RoB | |
| Relapses (6) | Very low | Very serious RoB, serious inconsistency | |
| Improvement in PET-CT (2) | Very low | Very serious RoB | |
| Reduction in prednisolone dose–mean (3) | Very low | Very serious RoB, serious inconsistency | |
| Reduction in prednisolone dose–median (8) | Very low | Very serious RoB, serious inconsistency | |
| Cyclophosphamide (32, 34, 53) | At least partial clinical response (2) | Very low | Serious RoB, serious imprecision |
| Angiographic stabilization (1) | Very low | Serious RoB, serious imprecision | |
| Relapses (1) | Very low | Serious RoB, serious imprecision | |
| Methotrexate (33, 64) | At least partial clinical response (2) | Very low | Serious RoB |
| Angiographic stabilization (1) | Very low | Serious RoB | |
| Relapses (1) | Very low | Serious RoB, serious imprecision | |
| Azathioprine (35, 64) | At least partial clinical response (2) | Very low | Serious RoB |
| Angiographic stabilization (1) | Very low | Serious RoB | |
| Relapses (1) | Very low | Serious RoB | |
| Cyclophosphamide + methotrexate (38) | At least partial clinical response (1) | Very low | Serious RoB, serious imprecision |
| Normalization of inflammatory markers (1) | Very low | Serious RoB, serious imprecision | |
| Relapses (1) | Very low | Serious RoB, serious imprecision | |
| Mycophenolate (39, 41, 58) | At least partial clinical response (3) | Very low | Serious RoB, serious imprecision |
| Angiographic stabilization (1) | Very low | Serious RoB | |
| Reduction in prednisolone dose–mean (3) | Very low | Serious RoB | |
| Leflunomide (42, 82, 99) | At least partial clinical response (3) | Very low | Serious RoB |
| Angiographic stabilization (2) | Very low | Serious RoB | |
| Relapses (1) | Very low | Serious RoB | |
| Reduction in prednisolone dose–mean (2) | Very low | Serious RoB | |
| Cyclosporine (64) | At least partial clinical response (1) | Very low | Serious RoB, serious imprecision |
| Tacrolimus (64) | At least partial clinical response (1) | Very low | Serious RoB, serious imprecision |
| Rituximab (71, 75) | At least partial clinical response (2) | Very low | Serious RoB, serious imprecision |
| Angiographic stabilization (1) | Very low | Serious RoB, serious imprecision | |
| Relapses (1) | Very low | Serious RoB | |
| Improvement in PET-CT (1) | Very low | Serious RoB, serious imprecision | |
| Reduction in prednisolone dose–mean (1) | Very low | Serious RoB | |
| Reduction in prednisolone dose–median (1) | Very low | Serious RoB | |
| Tofacitinib (86) | At least partial clinical response (1) | Very low | Serious RoB, serious imprecision |
| Angiographic stabilization (1) | Very low | Serious RoB, serious imprecision | |
| Reduction in prednisolone dose–mean (1) | Very low | Serious RoB | |
*Evidence from all observational studies (controlled and uncontrolled) was downgraded for certainty of evidence due to study design
bDMARD biologic disease-modifying antirheumatic drugs, cDMARD conventional disease-modifying anti-rheumatic drugs, BVAS Birmingham Vasculitis Activity Score, PET-CT positron emission tomography computerized tomography, RoB risk of bias, TNFi tumour necrosis factor inhibitors