Treatment-to-Target With Apremilast in Psoriatic Arthritis: The Probability of Achieving Targets and Comprehensive Control of Disease Manifestations

Abstract

Objective: The present study was undertaken to evaluate the probability of achieving the Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) treatment targets of remission or low disease activity (LDA) with apremilast based on disease activity categories and corresponding responses in arthritis and other domains of psoriatic arthritis (PsA) not included in the cDAPSA.

Methods: Pooled analyses from the Psoriatic Arthritis Long-term Assessment of Clinical Efficacy studies 1, 2, and 3 were performed. Probability analyses assessing the likelihood of achieving cDAPSA treatment targets by week 52 were performed using multiple imputation for discontinuations and missing values. Longitudinal analyses were performed in patients grouped by cDAPSA category at week 52.

Results: Among 494 patients in the probability analyses, 46.9% with moderate disease activity and 24.9% with high disease activity at baseline achieved treatment targets (remission or LDA) by week 52. For patients with moderate disease activity at baseline, small improvements (cDAPSA reductions ≥30%) by week 16 were associated with achieving targets. Patients achieving remission or LDA by week 16 had high probabilities of remaining at treatment targets at week 52. Of 375 patients with cDAPSA components available at week 52, achieving targets with apremilast was associated with continuous disease activity improvements and no or mild arthritis and other PsA manifestations.

Conclusion: The probability of achieving treatment targets (remission or LDA) at week 52 was greater for patients with moderate versus high disease activity at baseline. At a mean level, partial improvements by week 16 were associated with achieving treatment targets. Patients receiving apremilast who achieved cDAPSA targets by week 52 also had no or mild arthritis or other PsA manifestations.

Trial registration: ClinicalTrials.gov NCT01172938 NCT01212757 NCT01212770.

© 2020 The Authors. Arthritis Care & Research published by Wiley Periodicals, Inc. on behalf of American College of Rheumatology.

Figures

Figure 1

Probabilities (by multiple imputation) of achieving Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) disease status at week 52 by baseline cDAPSA category. Percentages represent the proportion of patients in each cDAPSA category at baseline (high disease activity [HDA], moderate disease activity [Mod], low disease activity [LDA], and remission [REM] at week 52 = 100%). REM score ≤4; LDA score >4 to ≤13; Mod score >13 to ≤27; and HDA score >27. * = patients randomized to receive apremilast 30 mg twice a day with cDAPSA scores available at baseline (n = 494).

Figure 2

Probabilities (by multiple imputation) of achieving Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) response category at week 52 by week 16 cDAPSA response category in patients with moderate disease activity (Mod) at baseline (A) and patients with high disease activity (HDA) at baseline (B). Percentages represent the proportion of patients in each cDAPSA category at week 16 (HDA, Mod, low disease activity [LDA], and remission [REM] at week 52 = 100%). REM score ≤4; LDA score >4 to ≤13; Mod score >13 to ≤27; and HDA score >27. * = patients randomized to receive apremilast 30 mg twice a day at baseline with Mod (n = 121). † = patients randomized to receive apremilast 30 mg twice a day at baseline with HDA (n = 367).

Figure 3

Disease activity through week 52 (n = 375) by Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) (score range 0–154) category in patients receiving apremilast 30 mg twice a day from baseline, including patients randomized at baseline who had cDAPSA components available at week 52. Data are as observed. Remission (REM) score ≤4; low disease activity (LDA) score >4 to ≤13; moderate disease activity (Mod) score >13 to ≤27; and high disease activity (HDA) score >27. Error bars indicate the SEM.

Figure 4

Musculoskeletal disease activity by Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) category at week 52 for swollen joint count (SJC) (A) and tender joint count (TJC) (B), including patients randomized at baseline who had cDAPSA components available at week 52. Data are as observed. Remission (REM) score ≤4; low disease activity (LDA) score >4 to ≤13; moderate disease activity (Mod) score >13 to ≤27; and high disease activity (HDA) score >27. Error bars indicate the SEM.

Figure 5

Nonmusculoskeletal disease activity by Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) category at week 52. The nonmusculoskeletal disease outcomes include dactylitis count in patients with dactylitis at baseline (A), enthesitis in patients with enthesitis at baseline as measured using the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) (B), Psoriasis Area and Severity Index (PASI) response in patients with psoriasis‐involved body surface area ≥3% at baseline (C), and physical function as measured using the Health Assessment Questionnaire disability index (HAQ DI) (D), including patients randomized at baseline who had cDAPSA components available at week 52. Data are as observed. Remission (REM) score ≤4; low disease activity (LDA) score >4 to ≤13; moderate disease activity (Mod) score >13 to ≤27; and high disease activity (HDA) score >27. Error bars indicate the SEM.