Table 6

Trials with an active comparator in patients with axSpA

StudyStudy designTypes of patientsTreatment groupsN patientsTime point (weeks)ASAS20 (%)p ValueASAS40 (%)p ValueRisk of bias
Giardina et al50RCT open-labelr-axSpA* TNFi-naïveINF 5 mg/Kg Q6W IV251275NS55NSHigh
ETA 50 mg QW SC251260REF43REF
Braun et al 51 (ASCEND)RCT double-blindr-axSpA* TNFi-naïveETA 50 mg QW SC3791675.9<0.00159.8<0.001Low
SSZ 3g/day oral1871652.9REF32.6REF
Song et al 52 (ESTHER)RCT open-labelaxSpA† TNFi-naïveETA 25 mg BiW SC4048850.001700.001Unclear
SSZ 2–3g/day oral364842REF31REF
Park et al 58 (PLANETAS)RCT double-blind (non-inferiority trial)r-axSpA* TNFi-naïveCT-P13 5 mg/Kg Q6W IV1253070.551.8Low
INF 5 mg/Kg Q6W IV1253072.447.4
Sieper et al 55 (INFAST-1)RCT double-blindaxSpA† TNFi-naïve not refractory to NSAIDsINF 5 mg/Kg+NPX1052881.00.3075.20.03Low
Viapiana et al 57CCT open-labelr-axSpA*INF 5 mg/Kg Q6W IV302469NS45NSHigh
TNFi-naïveNeridronate 100 mg Q4W IV302468REF39REF
Mok et al 56RCT open-labelaxSpA† TNFi-naïveGOL 50 mg Q4W SC204865NS35NSUnclear
PAM 60 mg Q4W IV94856REF11REF
  • *According to the modified New York criteria.

  • †According to the ASAS axSpA criteria.

  • axSpA, axial spondyloarthritis; CCT, controlled clinical trial; ETA, etanercept; GOL, golimumab; INF, infliximab; IV, intravenous; NA, not applicable; NPX, naproxen; NS, non-significant (p>0.05); NSAIDs, Nonsteroidal anti-inflammatory drug; PAM, pamidronate; PBO, placebo; Q4W, every 4 weeks; Q6W, every 6 weeks; QW, every week; r-axSpA, radiographic axial spondyloarthritis; RCT, randomised controlled trial; REF, reference; SC, subcutaneous; SSZ, sulfasalazine; TNFi, tumour necrosis factor inhibitor.