Table 2

Efficacy outcome measures at week 2, week 16 and week 52†

Week 2Week 16Week 52
Placebo n=109Apremilast n=110Placebo n=109Apremilast n=110Placebo/Apremilast n=91Apremilast n=80
ACR20, n/m (%)7/109 (6.4)18/110 (16.4)*22/109 (20.2)42/110 (38.2)‡54/90 (60.0)53/79 (67.1)
ACR50, n/m (%)2/109 (1.8)3/110 (2.7)5/109 (4.6)20/110 (18.2)‡26/91 (28.6)29/79 (36.7)
ACR70, n/m (%)0/109 (0.0)0/110 (0.0)0/109 (0.0)7/110 (6.4)*7/91 (7.7)17/80 (21.3)
DAS-28 (CRP), mean change−0.31−0.59*−0.39−1.07§−1.46−1.71
SJC, mean % change−17.5−27.74.2−46.4§−71.9−77.5
TJC, mean % change−16.2−14.82.5−32.3‡−61.4−70.4
GEI (0–6), mean change¶−0.4−1.1*−0.4−1.5‡−1.4−1.6
GEI=0¶, n/m (%)10/51 (19.6)20/56 (35.7)17/51 (33.3)26/56 (46.4)24/43 (55.8)30/43 (69.8)
HAQ-DI score (0–3), mean change−0.05−0.13*−0.06−0.21*−0.32−0.40
HAQ-DI MCID ≥0.35, n/m (%)13/109 (11.9)24/110 (21.8)30/109 (27.5)39/110 (35.5)38/91 (41.8)40/80 (50.0)
SF-36v2 PF, mean changeNANA−1.042.43‡5.116.00
SF-36v2 PCS, mean changeNANA−0.314.03§5.646.49
Improvement in morning stiffness severity, n/m (%)23/109 (21.1)47/110 (42.7)‡28/109 (25.7)51/110 (46.4)‡52/91 (57.1)46/80 (57.5)
Morning stiffness duration (minutes), median % change0.000.00*0.00−33.33‡−41.67−55.00
  • *P<0.05 versus placebo; based on a Cochran-Mantel-Haenszel test for binary parameters and mixed-effects model for repeated measures for continuous parameters (except using stratified Van Elteren test for morning stiffness duration, with last-observation-carried-forward approach for missing data).

  • †Full analysis set was used for weeks 2 and 16; for response parameters, patients without sufficient data (observed or imputed) for the determination of response status were categorised as non-responders. Week 52 analyses were as observed; actual number of patients may vary for each outcome depending on availability of data.

  • ‡P<0.005; §P≤0.0001 versus placebo; based on a Cochran-Mantel-Haenszel test for binary parameters and mixed-effects model for repeated measures for continuous parameters (except using stratified Van Elteren test for morning stiffness duration, with last-observation-carried-forward approach for missing data).

  • ¶Evaluated in patients with enthesitis at baseline (GEI >0).

  • ACR20, 20% improvement in modified American College of Rheumatology response criteria; DAS-28 (CRP), 28-joint count Disease Activity Score using C reactive protein; GEI, Gladman Enthesitis Index; HAQ-DI, Health Assessment Questionnaire-Disability Index; MCID, minimal clinically important differences; NA, not assessed at time point; n/m, number of responders/number of patients with sufficient data for evaluation; PCS, physical component summary; PF, Physical Functioning domain; SF-36v2, 36-item Short-Form Health Survey version 2.