Efficacy in psoriatic arthritis
ADEPT: A randomized, controlled trial of patients with moderate to severe active psoriatic arthritis (PsA)1-3
ADEPT evaluated the efficacy and safety of HUMIRA in patients with active PsA over 48 weeks
- 24-week, double-blind study followed by an open-label extension (OLE) phase with HUMIRA
ADEPT study design2,3
ADEPT was a 24-week, randomized, double-blind, placebo-controlled study of 313 adults with moderately to severely active PsA (≥3 swollen joints and ≥3 tender or painful joints) and had either active psoriatic skin lesions or a documented history of psoriasis. Patients were required to have a history of inadequate response or an intolerance to NSAID therapy for PsA. Patients with psoriatic involvement of ≥3% of BSA were evaluated for PASI response. Treatment consisted of HUMIRA 40 mg or placebo EOW given subcutaneously. Patients on MTX at enrollment (158/313) and taking a stable dose of ≤30 mg/week for >1 month could remain on the same dose. After week 12, patients who failed to have at least a 20% decrease in both swollen and tender joint counts on 2 consecutive visits could receive rescue therapy with corticosteroids or DMARDs. All patients who completed the 24-week study were eligible for long-term treatment with HUMIRA in an OLE study. Co-primary endpoints were ACR 20 response at week 12 and change in mTSS for HUMIRA at week 48 vs placebo at week 24.
OLE: 285 patients entered the 120-week extension trial measuring the effects of treatment with HUMIRA on the efficacy endpoints of the randomized, controlled study. 115 patients received HUMIRA 40 mg EOW. All patients had a radiographic measure at baseline, week 24, week 48, and at week 96 or week 144. In the analysis of the mean change in mTSS through week 144, data were imputed. For patients who didn’t have a week 144 mTSS, week 96 mTSS was used.
ACR=American College of Rheumatology; ACR 20=improvement of at least 20% in the ACR core criteria; BSA=body surface area; DMARDs=disease-modifying antirheumatic drugs; EOW=every other week; MTX=methotrexate; mTSS=modified total Sharp score; OLE=open-label extension; PASI=Psoriasis Area and Severity Index
HUMIRA significantly improved signs and symptoms of PsA1,2
HUMIRA significantly inhibited joint damage progression compared to placebo1-3
- At week 48 of the OLE
— HUMIRA-treated patients had a mean change from baseline of -0.2 ± 4.9 SD in mTSS compared to mean change of +0.9 ± 3.1 SD at week 24 in placebo-treated patients (P<0.001; co-primary endpoint)1
— mTSS scores at baseline were 23.4 for HUMIRA and 22.1 for placebo.
— 87% (n=133) of HUMIRA-treated patients showed no radiographic progression3†
- At week 24, 91% (n=144) of HUMIRA-treated patients showed no radiographic progression† compared with 71% (n=152) of placebo-treated patients3
The mTSS, which included distal interphalangeal (DIP) joints (ie, not identical to the TSS used for rheumatoid arthritis), was used by readers blinded to treatment group to assess the radiographs.1 For HUMIRA patients who did not have an mTSS at week 48, the mTSS was imputed by linear extrapolation using the baseline and week 24 scores.4
ADEPT OLE: radiographic assessment through 144 weeks5
- Patients treated with HUMIRA 40 mg EOW (n=115) from baseline had a mean change of 0.5 ± 4.20 in mTSS at week 144
— All patients had a radiographic measure at baseline, week 24, week 48, and at week 96 or week 144. In this analysis, data are imputed.
OLE populations generally consist of treatment responders. Patients who are unable to tolerate the drug or who do not respond to the drug drop out.
† Defined as a change in mTSS of ≤ 0.5 from baseline.