Table 1

Treatment targets and timeline definition in trials of ankylosing spondylitis and psoriatic arthritis

Measure of disease activityTarget definitionAssessment afterStudy (drug)
Ankylosing spondylitis
 ASAS≥20% responseWeek 12 (OLE)ATLAS (ADA)*11
 BASDAI<3 at both current and prior assessmentWeek 36ASSERT (IFX)†12
 ASAS≥40% responseWeek 12Haibel (ADA)*14
 BASDAI≥50% reduction, or ≤3Week 22 and 38CANDLE (IFX)†15
 BASDAI≥20% reductionMonth 3Jois (IFX)17
≥50% reductionMonth 6
 BASDAI≥40% reductionWeek 14Cherouvim (IFX)*18
 ESR≥1 mm reduction per week: escalate
≤20 (women)/≤10 (men) mm/h for step down
Remission: ESR ≤10 (men ≤5) and
BASDAI, BASFI, BASG, BASMI scores mean <1: taper
Weekly for escalation
Month 6 for step down
Darmawan (IS)†21
Combined/alternative targets
 Total back pain (VAS), MST (min)≥20% reduction in both back pain and MSTWeek 16GO-RAISE (GOL)†13
 BASDAI, IFX serum level<40 and
5.0 μg/ml
After 4th IFX (∼22 weeks)Meric (IFX)*16
 BASDAI, ESR/CRP<4 (BASDAI) or
<30 mm/h ESR and <5 mg/l CRP
Week 38Collantes (IFX)†19
 MST (VAS), pain (VAS), ESR≥20% reduction in 2/3Week 4Van Denderen (mesalazine)*20
 BASDAI, ESR/CRP≥2 patients. BASDAI reduction and
≥20% ESR/CRP reduction
Week 2, then 6-weeklyCheung (IFX)22
 Q1: disease has remained under control?
 Q2: disease has been worsening?
VAS pain, BASDAI
No relapse; definition:
Q1 ‘Yes’ and Q2 ‘No’ and
either
 <2/10 pain increase and
 <1/10 BASDAI increase
≥4 weeks after stopping for on-demand
week 40 for dose escalation
Breban (IFX)†23
 BASMI, PhysGANo relapse; definition:
≤4 BASMI and
≤4 PhysGA
26 weeks after stopBraun (IFX)†24
Psoriatic arthritis
 TJC and SJC≥20% reduction12 weeksADEPT (ADA)25
 TJC and SJC≥10% reduction16 weeksGO-REVEAL (GOL)26
 TJC and SJC combined N≥20% reduction38 and 46 weeksIMPACT 2 (IFX)27
 Joint count ‘actively inflamed’≥30% reduction14 weeksFeletar (IFX)28
 Joint count≥40% reduction3 monthsRahman (SSZ)29
 PGA≥40% reduction14 weeksCherouvim (IFX)18
 BASDAI, ESR/CRP<4 (BASDAI) or
<30 mm/h ESR and <5 mg/l CRP
Week 38 (cave diff AB 30/text38)Collantes (IFX)†19
Psoriasis
 MPSSMPSSpresent visit >MPSSprevious visit−0.2* (MPSSprevious visit−MPSSbaseline)Max 18 weeksDe Jong (MTX)37
 PASIImprovement >25%6 weeksBeissert (CsA, MMF)38
 PASIImprovement ≥75%12 weeksNevin (CsA)39
  • *Target measure is identical with primary end point measure.

  • †Target measure is not identical with primary end point measure.

  • ADA, adalimumab; ADEPT, Adalimumab Effectiveness in Psoriatic Arthritis Trial; ASAS, Ankylosing Spondylitis Assessment Study; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; BASG, Bath Ankylosing Spondylitis Global Score; BASMI, Bath Ankylosing Spondylitis Metrology Index; CRP, C-reactive protein; CsA, ciclosporin; DMARD, disease-modifying antirheumatic drug; ESR, erythrocyte sedimentation rate; GOL, golimumab; IFX, infliximab; IS, immunosuppressant therapy (consisting of combined DMARDs); mesa, mesalazine; MMF, mycophenolate mofetil; MPSS, Modified Psoriasis Severity Score; MST, morning stiffness; MTX, methotrexate; OLE, open label extension; PASI, Psoriasis Area Severity Index; PGA, Patient global assessment of disease activity; PhysGA, physician global assessment; Q1, Q2, question 1 and 2; SJC, swollen joint count; SSZ, sulfasalazine; TJC, tender joint count; VAS, visual analogue scale.