Table 5

Ability to detect change in RCTs

Author (year)Study descriptionSample sizeTime pointPrimary comparisonPercentage of patients achieving MDA
TotalPsA only
Coates and Helliwell (2010)22Post hoc analysis of two RCTs to validate the MDA criteriaPhase 2=6363Week 16Infliximab48
Placebo3
P value<0.0001
Phase 3=157157Week 24Infliximab52
Placebo*21
P value<0.001
Coates et al (2016)30Post hoc analysis of phase III RCT397397Week 16Secukinumab 150 mg23
Secukinumab 300 mg28
Placebo10
Week 52Secukinumab 150 mg33
Secukinumab 300 mg35
Gladman et al (2017)41Phase III RCT, placebo394394Week 12Tofacitinib 5 mg22.9
Tofacitinib 10 mg21.2
Placebo14.5
P valueNR
Week 28Tofacitinib 5 mg23.7
Tofacitinib 10 mg23.5
Placebo/tofacitinib 5 mg18.2
Placebo/tofacitinib 10 mg29.2
P valueNR
Kavanaugh et al (2016)28Post hoc analysis of RCT, placebo to explore relationship of MDA to radiographic progression395395Week 14Golimumab23.5
Placebo1
P value<0.0001
Week 24Golimumab28.1
Placebo7.7
P value<0.0001
Week 52Golimumab42.4
Placebo30.2
P value<0.0001
≥5 consecutive time pointsGolimumab24.9
Placebo12.3
P value0.007
≥6 consecutive time pointsGolimumab16.6
Placebo2.8
P value0.000
≥7 consecutive time pointsGolimumab11.4
Placebo0
P value0.000
Mease et al (2017)31Phase III RCT
(week 24—active treatment end of study; weeks 48–144—open-label extension)
313136Week 24Adalimumab36.4
Placebo5.8
P value<0.001
Week 48
(open-label extension)
Adalimumab43.1
Adalimumab naïve32.2
Week 96
(open-label extension)
Adalimumab37.9
Adalimumab naïve27.1
Week 144
(open-label extension)
Adalimumab34.5
Adalimumab naïve22.0
Mease et al (2014)42Post hoc analysis of RCT data to explore relationship with MDA409409Week 24Certolizumab pegol
(200 mg and 400 mg)
33.3; 34.1
Placebo5.9
P value<0.001
Mease et al (2015)43Post hoc analysis of RCT data to explore relationship with MDA409409Week 48 (imputation)Certolizumab pegol
(combined patients randomised to active treatment at baseline)
38.8
Week 96 (imputation)Certolizumab pegol
(combined patients randomised to active treatment at baseline)
41.0
Mease et al (2017)19Post hoc analysis of RCT, placebo to investigate achievement of MDA424424Week 24Abatacept11.7
Placebo8.1
P value0.205
Week 52
(open-label extension)
Abatacept17.4
Placebo/abatacept18.5
P valueNR
Mease et al (2017)44Phase III RCT to investigate achievement of MDA

422
422Week 12Tofacitinib
(5 mg and 10 mg)
26.0; 26.0
Adalimumab25.0
Placebo (pooled)7.0
P valueNR
Week 52Tofacitinib
(5 mg and 10 mg)
37.0; 43.0
Adalimumab40.0
Placebo/tofacitinib
(5 mg and 10 mg)
31.0; 34.0
P valueNR
Nash et al (2017)45Post hoc analysis of RCT, placebo to investigate achievement of MDA363363Week 24Ixekizumab
(2 weeks; 4 weeks)
24.0; 28.0
Placebo3
P value<0.0001
  • *Forty-seven patients in the placebo group entered the early escape arm at week 16 and received infliximab.

  • MDA, minimal disease activity; NR, not reported; PsA, psoriatic arthritis; RCT, randomised controlled trial.