Research ArticlePsoriatic Arthritis
Open Access

Canadian Adalimumab Postmarketing Observational Epidemiological Study Assessing Effectiveness in Psoriatic Arthritis (COMPLETE-PsA): 12-month Results of Comparative Effectiveness of Adalimumab and nbDMARDs

Majed M. Khraishi, Valencia P. Remple, Samuel Silverberg, Jacqueline C. Stewart, Brandusa Florica and Louis Bessette
The Journal of Rheumatology May 2022, 49 (5) 454-464; DOI: https://doi.org/10.3899/jrheum.200609

Article Figures & Data

Figures

  • Figure 1.
    Figure 1.

    (A–E). ≠ Represents adjusted means, specifically the least squares mean estimates derived from linear mixed-effects model with repeated measures, adjusting for baseline levels of the respective disease outcome, visit, and the interaction effect of treatment with visit. * Fixed at mean baseline levels. Bold P values indicate statistical significance. CRP: C-reactive protein; DAPSA28: Disease Activity Index for Psoriatic Arthritis in 28 joints; DAS28: Disease Activity Score in 28 joints; ESR: erythrocyte sedimentation rate; nbDMARD: nonbiologic disease-modifying antirheumatic drug; PGA: physician global assessment.

  • Figure 1. C–E.
    Figure 1. C–E.
  • Figure 2.
    Figure 2.

    (A–E). ≠ Adjusted means, specifically the least squares mean estimates derived from linear mixed-effects model with repeated measures, adjusting for baseline levels of the respective disease outcome, visit, and the interaction effect of treatment with visit. * Fixed at mean baseline levels. Bold P values indicate statistical significance. SF-12 was not assessed at 3 months, as per the recommendations for follow-up assessments. HAQ-DI: Health Assessment Questionnaire–Disability Index; MCS: mental component summary; nbDMARD: nonbiologic disease-modifying antirheumatic drug; PCS: physical component summary; PtGA: patient global assessment; SF-12: 12-item Short Form Health Survey.

  • Figure 2. (C–E).
    Figure 2. (C–E).
  • Figure 3.
    Figure 3.

    (A–C). † MDA based on a modified measure, which required the presence of 5 out of the 7 following outcomes: TJC ≤ 1, SJC ≤ 1, BSA ≤ 3%, pain VAS ≤ 15, PtGA ≤ 20, HAQ-DI ≤ 0.5, and absence of enthesitis. Bold P values indicate statistical significance. ACR50/70: American College of Rheumatology 50% or 70% response; BSA: body surface area; HAQ-DI: Health Assessment Questionnaire–Disability Index; HR: hazard ratio; MDA: minimal disease activity; mMDA: modified minimal disease activity; nbDMARD: nonbiologic disease-modifying antirheumatic drug; NSAID: nonsteroidal antiinflammatory drug; PtGA: patient global assessment; SJC: swollen joint count; TJC: tender joint count; VAS: visual analog scale.

  • Figure 3. (C).
    Figure 3. (C).
  • Figure 4.
    Figure 4.

    Patients not switching/initiating bDMARD up until month 12 were right censored. bDMARD: biologic disease-modifying antirheumatic drug; nbDMARD: nonbiologic disease-modifying antirheumatic drug; NSAID: nonsteroidal antiinflammatory drug.

Tables

  • Table 1.

    Participant characteristics at baseline.

      Treatment Group 
    ADA, n = 277nbDMARD, n = 148P
    Age, yrs, mean (SD)52.0 (12.1)50.5 (12.6)0.24
    Sex, male145 (52.3)64 (43.2)0.07
    Race   
          White255 (92.1)136 (91.9)0.74
          Asian10 (3.6)8 (5.4) 
          Other12 (4.4)4 (2.7) 
    Tobacco use a   
          Never smoked118 (43.9)80 (54.1)0.14
          Former smoker108 (40.1)48 (32.4) 
          Current smoker43 (16.0)20 (13.5) 
    Employeda144 (52.4)95 (64.6)0.02
    PsA duration, yrs, mean (SD)4.8 (6.6)4.1 (7.7)0.40
    PsO duration, yrs, mean (SD)14.0 (13.0)12.8 (13.9)0.40
    Family history of PsAa101 (36.6)64 (43.2)0.20
    RF+a15 (5.5)5 (3.4)0.20
    Morning stiffness, min/d, mean (SD)83.1 (98.2)61.8 (77.4)0.02
    BSA affecteda, %   
          < 3150 (56.3)93 (64.5)0.15
          3–1077 (29.0)40 (27.8) 
          11–2023 (8.6)8 (5.6) 
          > 2016 (6.0)3 (2.1) 
    Dominant PsA subtypea   
          Symmetric polyarthritis176 (68.2)79 (57.2)0.06
          Asymmetric oligoarthritis59 (22.9)48 (34.8) 
          Distal interphalangeal arthropathy7 (2.7)6 (4.3) 
          Spondylitis14 (5.4)5 (3.6) 
          Arthritis mutilans2 (0.8)0 (0.0) 
    No. of prior/discontinued nbDMARDsb  < 0.001
          077 (27.8)73 (49.3) 
          191 (32.9)51 (34.5) 
          ≥ 2109 (39.4)24 (16.2) 
    Medication use  NA
          ADA277 (100.0)NA 
          NSAIDs121 (43.7)82 (55.4) 
          nbDMARDs222 (80.1)148 (100.0) 
                Apremilast0 (0.0)2 (1.4) 
                AZA3 (1.1)2 (1.4) 
                CSA2 (0.7)0 (0.0) 
                Gold2 (0.7)0 (0.0) 
                HCQ53 (19.1)33 (22.3) 
                LEF29 (10.5)31 (20.9) 
                MTX182 (65.7)120 (81.1) 
                SSZ49 (17.7)34 (23.0) 
    Enthesitisa77 (28.4)33 (23.4)0.28
    Dactylitisa71 (26.2)53 (36.3)0.03
    Morning stiffness, min/d, mean (SD)83.1 (98.2)61.8 (77.4)0.02
    DAPSA28, mean (SD)39.3 (18.2)31.3 (16.4)< 0.001
    DAS28, mean (SD)4.8 (1.2)4.3 (1.1)0.001
    TJC28, mean (SD)8.9 (6.2)7.4 (6.6)0.02
    SJC28, mean (SD)7.4 (5.0)5.9 (4.6)0.003
    PGA (100-mm VAS), mean (SD)59.4 (19.5)51.0 (21.8)< 0.001
    PtGA (100-mm VAS), mean (SD)56.1 (24.1)45.1 (24.7)< 0.001
    Pain (100-mm VAS), mean (SD)58.5 (24.3)50.1 (24.0)0.002
    HAQ-DI, mean (SD)1.1 (0.7)0.8 (0.6)< 0.001
    SF-12 PCS34.7 (10.0)36.5 (10.8)0.24
    SF-12 MCS43.8 (11.7)44.5 (10.8)0.69
    ESR, mm/h, mean (SD)19.4 (17.8)16.2 (14.4)0.10
    CRP, mg/L, mean (SD)16.2 (41.1)12.3 (19.4)0.23

    • Values are n (%) unless otherwise indicated.

    • ↵aProportions based on patients with available data. Missing or unknown information for ADA- and nbDMARD-treated patients, respectively, were as follows: tobacco use (n = 8 and n = 0), employment status (n = 2 and n = 1) family history of PsA (n = 1 and n = 0), RF status (n = 3 and n = 0), BSA (n = 11 and n = 4), dominant PsA subtype (n = 19 and n = 10), enthesitis (n = 6 and n = 7), dactylitis (n = 6 and n = 2), morning stiffness (n = 12 and n = 7), DAPSA28 (n = 65 and n = 44), DAS28 (n = 49 and n = 33), TJC28 (n = 2 and n = 0), SJC28 (n = 2 and n = 1), PGA (n = 15 and n = 23), PtGA (n = 33 and n = 23), pain (n = 35 and n = 25), HAQ-DI (n = 34 and n = 23), SF-12 (n = 148 and n = 83), ESR (n = 87 and n = 49), and CRP (n = 36 and n = 23).

    • ↵b Excluding nbDMARDs initiated prior to baseline that were ongoing at baseline. ADA: adalimumab; AZA: azathioprine; BSA: body surface area; CRP: C-reactive protein; CSA: cyclosporine A; DAPSA: Disease Activity Index for Psoriatic Arthritis in 28 joints; DAS28: Disease Activity Score in 28 joints; ESR: erythrocyte sedimentation rate; HAQ-DI: Health Assessment Questionnaire–Disability Index; HCQ: hydroxychloroquine; LEF: leflunomide; MCS: mental component summary; PGA: physician global assessment; MTX: methotrexate; NA: not applicable; NSAID: nonsteroidal antiinflammatory drug; nbDMARD: nonbiologic disease-modifying antirheumatic drug; PCS: physical component summary; PsA: psoriatic arthritis; PsO: psoriasis; PtGA: patient global assessment; RF: rheumatoid factor; SF-12: 12-item Short Form Health Survey; SJC28: swollen joint count in 28 joints; SSZ: sulfasalazine; TJC28: tender joint count in 28 joints; VAS: visual analog scale.

  • Table 2.

    Baseline-adjusted GEE model with repeated measures for enthesitis, dactylitis, and BSA over 12 months.

     Treatment Group
     Adalimumab vs nbDMARD
    Adjusted* OR (95% CI)Pa
    Enthesitis (yes vs no)0.7 (0.4–1.2)0.17
    Dactylitis (yes vs no)0.4 (0.2–0.6)< 0.001b
    BSA affected (< 3% vs ≥ 3%)2.7 (1.5–5.0)0.002b

    • ↵aAdjusted for respective outcome at baseline.

    • ↵bStatistically significant. BSA: body surface area; GEE: generalized estimating equations; OR: odds ratio; nbDMARD: nonbiologic disease-modifying antirheumatic drug.

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Keywords

DISEASE-MODIFYING ANTIRHEUMATIC DRUGS
LONGITUDINAL STUDIES
NONSTEROIDAL ANTIINFLAMMATORY DRUGS
PSORIATIC ARTHRITIS

Keywords