Table 4

Study endpoints: ACR20 response—DAS28-CRP—MDA

Study acronymStudy groupTiming of evaluationACR20 response*DAS28-CRP†
(mean change, unless otherwise stated)
MDA‡
IMPACT 2 §11InfliximabWeek 1458%//
Week 2454%//
PlaceboWeek 1411%//
Week 2416%//
GO-REVEAL13Golimumab 50 mgWeek 1451%−1.38/
Week 2452%−1.43/
Golimumab 100 mgWeek 1445%−1.29/
Week 2461%−1.56/
PlaceboWeek 149%−0.18/
Week 2412%−0.12/
ADEPT14Adalimumab 40 mg every 2 weeksWeek 1258%//
Week 2457%//
PlaceboWeek 1214%//
Week 2415%//
SPIRIT-P1 ¶16Adalimumab 40 mg every 2 weeksWeek 2457.4%−1.74/
Ixekizumab every 2 weeksWeek 2462.1%−2.04/
Ixekizumab every 4 weeksWeek 2457.9%−1.96/
PlaceboWeek 2430.2%−0.84/
OPAL BROADEN17Tofacitinib 5 mgMonth 350%−1.326%
Month 1268%−1.937%
Tofacitinib 10 mgMonth 361%−1.626%
Month 1270%−2.043%
Adalimumab 40 mg every 2 weeksMonth 352%−1.525%
Month 1260%−1.940%
PlaceboMonth 333%−0.87%
Month 1258%−2.034%
RAPID-PsA °°19Certolizumab pegol every 2 weeksWeek 1258%//
Week 2463.8%/33.3%
Certolizumab pegol every 4 weeksWeek 1251.9%//
Week 2456.3%/34.1%
PlaceboWeek 1224.3%//
Week 2423.5%/5.9%
FUTURE 121Secukinumab 150 mgWeek 2450%−1.62/
Secukinumab 75 mgWeek 2450.5%−1.67/
PlaceboWeek 2417.3%−0.77/
FUTURE 222Secukinumab 300 mgWeek 2454%−1.61/
Secukinumab 150 mgWeek 2451%−1.58/
Secukinumab 75 mgWeek 2429%−1.12/
PlaceboWeek 2415%−0.96/
FUTURE 323Secukinumab 300 mgWeek 2448.2%−1.56/
Secukinumab 150 mgWeek 2442%−1.24/
PlaceboWeek 2416.1%−0.64/
FUTURE 424Secukinumab 150 mg with loading regimenWeek 1641.2%−0.98/
Secukinumab 150 mg without loading regimenWeek 1639.8%−0.84/
PlaceboWeek 1618.4%−0.21/
FUTURE 525Secukinumab 300 mgWeek 1662.6%−1.49/
Secukinumab 150 mg with loading doseWeek 1655.5%−1.2914%
Secukinumab 150 mg without loading doseWeek 1659.5%−1.2910.6%
PlaceboWeek 1627.4%−0.632.6%
PSUMMIT 1§26Ustekinumab 45 mgWeek 2442.4%65.9% EULAR response**/
Ustekinumab 90 mgWeek 2449.5%67.6% EULAR response**/
PlaceboWeek 2422.8%34.5% EULAR response**/
PSUMMIT 2§28Ustekinumab 45 mgWeek 2443.7%54.4% EULAR response**/
Ustekinumab 90 mgWeek 2443.8%53.3% EULAR response**/
PlaceboWeek 2420.2%29.8% EULAR response**/
DISCOVER 1 §29Guselkumab every 4 weeksWeek 2459%−1.6130%
Guselkumab every 8 weeksWeek 2452%−1.4323%
PlaceboWeek 2452%−0.7011%
DISCOVER 2¶30Guselkumab every 4 weeksWeek 2464%−1.6219%
Guselkumab every 8 weeksWeek 2464%−1.5925%
PlaceboWeek 2433%−0.976%
ASTRAEA31AbataceptWeek 2439.4%/11.7%
PlaceboWeek 2422.3%/8.1%
OPAL BEYOND33Tofacitinib 5 mgMonth 350%−1.422.9%
Month 660%−1.623.7%
Tofacitinib 10 mgMonth 347%−1.221.2%
Month 649%−1.423.5%
PlaceboMonth 324%−0.614.5%
Month 651.9%−1.518.2%
PALACE 134Apremilast 20 mg two times per dayWeek 1630.4%//
Week 2426.4%−0.66/
Apremilast 30 mg two times per dayWeek 1638.1%//
Week 2436.6%−0.91/
PlaceboWeek 1619.0%//
Week 2413.3%−0.20/
PALACE 235Apremilast 20 mg two times per dayWeek 1637.4%−0.8/
Week 5252.9%%−1.1/
Apremilast 30 mg two times per dayWeek 1632.1%−0.7/
Week 5252.6%−1.3/
PlaceboWeek 1618.9%−0.3/
Week 5250.4%−1.2/
PALACE 336Apremilast 20 mg two times per dayWeek 1628%−0.57/
Week 5256%−1.2/
Apremilast 30 mg two times per dayWeek 1641%−0.77/
Week 5263%−1.4/
PlaceboWeek 1618%−0.28/
Week 5258.5%−1.3/
PALACE 437Apremilast 20 mg two times per dayWeek 1628.0%−0.62/
Week 5253.4%−1.4/
Apremilast 30 mg two times per dayWeek 1630.7%−0.67/
Week 5258.7%−1.4/
PlaceboWeek 1615.9%−0.16/
Week 5258.2%−1.2/
ACTIVE §38Apremilast 30 mg two times per dayWeek 1638.2%−1.07/
Week 2443.6%−1.26/
PlaceboWeek 1620.2%−0.39/
Week 2424.8%−0.76/
  • *Composite measure defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure (most often Health Assessment Questionnaire (HAQ)), Visual Analogue Pain Scale and erythrocyte sedimentation rate or CRP.

  • †The DAS28-CRP combines a tender joint count based on a 28-joint assessment, swollen joint count based on a 28-joint assessment, in addition to the general health patient global Visual Analogue Scale (VAS in mm) domains and CRP (in mg/L).

  • ‡A good or moderate EULAR DAS28-CRP response.

  • §Studies using a minimum level of baseline CRP as inclusion criterion, also including a radiographic outcome measure.39 40

  • ¶Studies using a minimum level of baseline CRP as inclusion criterion (table 2).

  • **A patient is classified as achieving MDA when fulfilling at least five of the following seven criteria: tender joint count 1 or less, swollen joint count 1 or less, PASI score 1 or less or BSA 3 or less, patient pain VAS score 15 or less, patient global disease activity VAS score 20 or less, HAQ-Disability Index score 0.5 or less and tender entheseal points 1 or less.

  • ACR, American College of Rheumatology; CRP, C reactive protein; DAS-28, Disease Activity Score-28; MDA, minimal disease activity; SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials.