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Time until onset of action when treating psoriatic arthritis: meta-analysis and novel approach of generating confidence intervals

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Abstract

Psoriatic arthritis (PsA) is associated with progressive joint destruction and reduced quality of life. The time until a drug treatment starts to show an effect (TOA) is important for preventing joint destruction. The objective was to assess the time until onset of action of drugs when treating PsA. A systematic review of PsA drug trials was performed. Outcomes were: time until 25% of patients (TOA) reached (1) ≥ 20%, (2) ≥ 50% improvement in modified American College of Rheumatology response criteria (ACR), (3) ≥ 75% reduction in Psoriasis Area and Severity Index (PASI75). 95% confidence intervals were calculated extracting data from graphs using a novel method. Meta-analysis was conducted. Two head-to-head trials show no difference between ixekizumab and adalimumab or adalimumab and tofacitinib for TOA-ACR outcomes. For PASI75, ixekizumab had a faster onset than adalimumab. Infliximab plus MTX was faster than MTX alone. Pooled results from 32 study arms for TOA-ACR20 (week [95% CI]) are: < 2 weeks: infliximab (1.18 [0.72–1.65]), ixekizumab (1.04 [0.80–1.28]), tofacitinib (10 mg 1.56 [1.14–1.98]); ≤ 4 weeks: adalimumab (1.95 [1.35–2.55]), secukinumab (75 mg 1.89 [0.16–3.62], 150 mg 2.13 [1.34–2.91], 300 mg 2.26 [1.75–2.76]), tofacitinib (5 mg 2.20 [1.41–2.99]); 4 + weeks: apremilast, ustekinumab. For TOA-ACR50, all pooled point estimates are > 4 weeks. For TOA-PASI75, the range is between 2.24 [1.65–2.84] for ixekizumab and 6.03 [3.76–8.29] for adalimumab. Indirect, mixed comparison suggest a faster onset of infliximab, ixekizumab and tofacitinib compared to apremilast, methotrexate and ustekinumab for ACR20, not ACR50. For PASI75, ixekizumab is faster than adalimumab.

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Abbreviations

ACR:

American College of Rheumatology

ACR20:

≥ 20% improvement in modified American College of Rheumatology response criteria

ACR50:

≥ 50% improvement in modified American College of Rheumatology response criteria

ADA:

Adalimumab

APR:

Apremilast

bDMARD:

Biological disease-modifying anti-rheumatic drug

BID:

Twice a day

BIW:

Twice weekly

BW:

Body weight

CASPAR:

Classification criteria for the diagnosis of psoriatic arthritis

CI:

Confidence intervals

CRP:

C-reactive protein

CSA:

Cyclosporine

csDMARD:

Conventional synthetic disease-modifying anti-rheumatic drug

CZP:

Certolizumab pegol

d:

Day

EE:

Early escape

ES:

Point estimate

ESR:

Erythrocyte sedimentation rate

ETA:

Etanercept

EULAR:

European League against Rheumatism

GOL:

Golimumab

GRAPPA:

Group for research and assessment of psoriasis and psoriatic arthritis

GUS:

Guselkumab

Hx:

History of

ICTRP:

The International Clinical Trials Registry Platform

INF:

Infliximab

IQR:

Interquartile range

iv:

Intravenous

IXE:

Ixekizumab

LE:

Lesion

LEF:

Leflunomide

LES:

Least squares

MTX:

Methotrexate

NA:

Not available

NI:

No information

NR:

Not restricted

NSAID:

Non-steroidal anti-inflammatory drug

PASI:

Psoriasis Area and Severity Index

PASI75:

≥ 75% reduction in Psoriasis Area and Severity Index

PBO:

Placebo

PGA:

Physician’s global assessment

PICOS:

Participants, interventions, comparisons, outcomes, study design

PJC:

Painful joint count

PRED:

Prednisolone

PRISMA:

Preferred reporting items for systematic reviews and meta-analyses

PsA:

Psoriatic arthritis

PsARC:

Psoriatic arthritis response criteria

Pso:

Cutaneous psoriasis

pts:

Patients

Q12W:

Every 12 weeks

Q1W:

Once per week

Q2W:

Every 2 weeks

Q4W:

Every 4 weeks

QD:

Once per day

RA:

Rheumatoid arthritis

RF:

Rheuma factor

sc:

Subcutaneous

SD:

Standard deviation

SE:

Standard error

SEC:

Secukinumab

SJC:

Swollen joint count

SSZ:

Sulfasalazine

tbc:

Tuberculosis

TJC:

Tender joint count

TOF:

Tofacitinib

tsDMARD:

Targeted synthetic disease-modifying anti-rheumatic drug

TOA:

Time until onset of action

TOA-ACR20:

Time until 25% of patients reach a ≥ 20% improvement in ACR criteria

TOA-ACR50:

Time until 25% of patients reach a ≥ 50% improvement in ACR criteria

TOA-PASI75:

Time until 25% of patients reach a ≥ 75% improvement in PASI

UST:

Ustekinumab

w:

Week/weeks

y/yrs:

Year/years

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Funding

The project was funded by Eli Lilly Germany. The funder had no role in the design, conduct, writing and editing of the project.

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Authors and Affiliations

  1. Division of Evidence-Based Medicine (dEBM), Department of Dermatology, Venerology und Allergy, Berlin Institute of Health, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Charitéplatz 1, 10117, Berlin, Germany

    Phuong Anh Pham, Corinna Dressler, Lisa Eisert, Alexander Nast & Ricardo Niklas Werner

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  4. Alexander Nast
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  5. Ricardo Niklas Werner
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Contributions

PAP: design, data acquisition, analysis and interpretation, and drafting the manuscript. CD: design, data acquisition, analysis and interpretation. LE: design, data acquisition. AN: conception, design. RNW: conception, design and data interpretation. All authors have revised the manuscript critically for important intellectual content and approved the final manuscript. Furthermore, all authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. No external writing or editing support was involved.

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Correspondence to Corinna Dressler.

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Conflict of interest

Authors Phuong Anh Pham (PAP), Dr. Corinna Dressler (CD), Ricardo N. Werner, MD (RNW) declare that they have no conflicts of interest. Author Lisa Eisert, MD (LE) has received seminar participation fees from Pfizer (Enbrel), Leo Pharma (Daivobet, Protopic, Enstilar). Author Prof. Alexander Nast, MD (AN) has received institutional research grants/participated as an investigator (without personal honoraria) in research projects, advisory activities or trials from the following companies with an interest in psoriatic arthritis: Lilly, Novartis, Dermira. AN has received personal honoraria for lectures/educational activities from the following companies which—to his knowledge—currently have no interest in psoriatic arthritis: Bayer Healthcare, Pierre Fabre, Boehringer Ingelheim.

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This article does not contain any studies with human participants or animals performed by any of the authors.

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Pham, P.A., Dressler, C., Eisert, L. et al. Time until onset of action when treating psoriatic arthritis: meta-analysis and novel approach of generating confidence intervals. Rheumatol Int 39, 605–618 (2019). https://doi.org/10.1007/s00296-019-04244-5

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