Effect of new biological and targeted-synthetic DMARDs on ASAS20 and ASAS40 responses in patients with axSpA
| Drug Study reference | Study design | Types of patients | Treatment groups | N patients | Time point (weeks) | ASAS20 (%) | p Value | NNT ASAS20 | ASAS40 (%) | p Value | NNT ASAS40 | Risk of bias |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secukinumab Baeten et al41 (MEASURE-1†) | Phase 3 RCT double-blind | r-axSpA* TNFi-naïve and TNFi-failure (≤1 TNFi) | 150 mg Q4W SC | 125 | 16 | 61 | <0.01 | 3.1 | 42 | <0.01 | 3.4 | Low |
| 75 mg Q4W SC | 124 | 16 | 60 | <0.01 | 3.2 | 33 | <0.01 | 5.0 | ||||
| Placebo | 122 | 16 | 29 | REF | REF | 13 | REF | REF | ||||
| Secukinumab Baeten et al41 (MEASURE-2†) | Phase 3 RCT double-blind | r-axSpA* TNFi-naïve and TNFi-failure (≤1 TNFi) | 150 mg Q4W SC | 72 | 16 | 61 | <0.01 | 3.0 | 36 | <0.01 | 4.0 | Low |
| 75 mg Q4W SC | 73 | 16 | 41 | NS | 7.7 | 26 | NS | 6.7 | ||||
| Placebo | 74 | 16 | 28 | REF | REF | 11 | REF | REF | ||||
| Ustekinumab Poddubnyy et al42 (TOPAS) | POC non-controlled open-label trial | r-axSpA* TNFi-naïve only | 90 mg SC | 20 | 24 | 75 | NA | NA | 65 | NA | NA | High |
| Tofacitinib van der Heijde et al43 | Phase 2 RCT double-blind | r-axSpA* TNFi-naïve only | 2 mg two times a day oral | 52 | 12 | 51.9 | NS | 9.3 | 42.3 | <0.05 | 4.4 | Low |
| 5 mg two times a day oral | 52 | 12 | 80.8 | <0.001 | 2.5 | 46.2 | <0.01 | 3.8 | ||||
| 10 mg two times a day oral | 52 | 12 | 55.8 | NS | 6.8 | 38.5 | <0.05 | 5.3 | ||||
| Placebo | 51 | 12 | 41.2 | REF | REF | 19.6 | REF | REF | ||||
| Apremilast Pathan et al44 | Phase 2 RCT double-blind | r-axSpA* TNFi-naïve only | 30 mg two times a day oral | 17 | 12 | 35.3 | 0.25 | 5.1 | 23.5 | 0.17 | 5.5 | Low |
| Placebo | 19 | 12 | 15.8 | REF | REF | 5.3 | REF | REF | ||||
| Rituximab Song et al45 | POC non-controlled open-label trial | r-axSpA* TNFi-naïve and TNFi-failure (≥1 TNFi) | 1000 mg IV | 20 | 24 | 40 | – | NA | 25 | – | NA | High |
| TNFi-naïve | 10 | 24 | 50 | – | NA | 40 | – | NA | ||||
| TNFi-failure | 10 | 24 | 30 | – | NA | 10 | – | NA | ||||
| Tocilizumab Sieper et al46 (BUILDER-1) | Phase 2 RCT double-blind | r-axSpA* TNFi-naïve only | TCZ 8 mg/Kg Q4W IV | 51 | 12 | 37.3 | NS | 10.2 | 11.8 | NS | 12.8 | Low |
| Placebo | 51 | 12 | 27.5 | REF | REF | 19.6 | REF | REF | ||||
| Sarilumab Sieper et al ARD47 (ALIGN) | Phase 2 RCT double-blind | r-axSpA* TNFi-naïve only | SAR 100 mg Q2W SC | 49 | 12 | 24.5 | NS | 200 | 14.3 | NS | 15.9 | Low |
| SAR 150 mg Q2W SC | 50 | 12 | 30.0 | NS | 16.7 | 16.0 | NS | 12.5 | ||||
| SAR 100 mg QW SC | 52 | 12 | 19.2 | NS | 20.8 | 5.8 | NS | 45.5 | ||||
| SAR 200 mg Q2W SC | 50 | 12 | 30.0 | NS | 16.7 | 18.0 | NS | 10.0 | ||||
| SAR 150 mg QW SC | 50 | 12 | 38.0 | NS | 7.1 | 20.0 | NS | 8.3 | ||||
| Placebo | 50 | 12 | 24.0 | REF | REF | 8.0 | REF | REF | ||||
| Abatacept Song et al48 | POC non-controlled open-label trial | r-axSpA* TNFi-naïve and TNFi-failure | ABA10 mg/Kg Q28D IV (TNFi-naive) | 15 | 24 | 26.7 | – | NA | 13.3 | – | NA | Low |
| ABA 10 mg/Kg Q28D IV (TNFi-failure) | 15 | 24 | 20 | NA | 0 | NA |
*According to the modified New York criteria.
†Loading dose in MEASURE-1: 10 mg/kg IV 0, 2, 4 weeks and MEASURE 2: 150/75 mg SC 0, 1, 2, 3 weeks.
ASAS, Assessment in SpondyloArthritis international Society; two times a day, twice a day; IV, intravenous; NA, not applicable; NNT, number needed to treat; NS, non-significant (p>0.05); POC, proof of concept; Q28D, every 28 days; Q2W, every 2 weeks; Q4W, every 4 weeks; QW, every week; r-axSpA, radiographic axial spondyloarthritis; RCT, randomised clinical trial; REF, reference group; SC, subcutaneous; TNFi, tumour necrosis factor inhibitor.