Trial Characteristics as Contextual Factors When Evaluating Targeted Therapies in Patients With Psoriatic Disease: A Meta-Epidemiologic Study

Christine Ballegaard, Tanja S Jørgensen, Marie Skougaard, Vibeke Strand, Philip J Mease, Lars E Kristensen, Lene Dreyer, Alice Gottlieb, Maarten de Wit, Robin Christensen, Simon Tarp

Research output: Contribution to journalJournal articleResearchpeer-review

Abstract

OBJECTIVE: To assess the importance of trial characteristics as contextual factors when evaluating the treatment effect of targeted therapies for patients with psoriatic disease.

METHODS: We identified randomized controlled trials (RCTs) evaluating targeted therapies approved for psoriatic arthritis (PsA) and psoriasis (8 biologics and apremilast). The effect of targeted therapies was analyzed in the 2 psoriatic conditions combined by using drug retention as a common outcome, and separately by using the American College of Rheumatology 20% improvement criteria (ACR20) for PsA and the Psoriasis Area Severity Index 75% improvement score (PASI75) for psoriasis. We explored potential effect modification of trial characteristics in stratified and meta-regression analyses. Odds ratios (ORs) were calculated and compared among the trial eligibility criteria via the ratio of ORs.

RESULTS: Forty-eight PsA and psoriasis trials (51 comparisons; 17,737 patients) were eligible. Overall retention was OR 2.16 (95% confidence interval [95% CI] 1.70-2.75) with higher odds for PsA trials compared with psoriasis trials (ratio of ORs 2.55 [95% CI 1.64-3.97]). The eligibility criteria "targeted therapy history," "minimum required disease duration," "required negative rheumatoid factor," and "required Classification Criteria for Psoriatic Arthritis criteria" were of importance for achieving ACR20 in PsA. The eligibility criterion "minimum required disease duration" was of importance for achieving PASI75 in psoriasis. A total of 7 PsA trials had rescue before time-point-of-retention reporting (adaptive trials).

CONCLUSION: From this exploratory meta-epidemiologic study, we now have evidence from RCTs to support the notion that patients with PsA are more likely to adhere to targeted therapies compared to patients with psoriasis. Furthermore, we identified a few contextual factors of importance in regard to achieving ACR20 in PsA trials and PASI75 in psoriasis trials.

Original languageEnglish
JournalArthritis Care & Research
Volume70
Issue number8
Pages (from-to)1206-1217
ISSN2151-464X
DOIs
Publication statusPublished - Aug 2018
Externally publishedYes

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Psoriatic Arthritis
Psoriasis
Epidemiologic Studies
Odds Ratio
Rheumatology
Randomized Controlled Trials
Confidence Intervals
Rheumatoid Factor
Meta-Analysis
History
Regression Analysis

Cite this

Ballegaard, C., Jørgensen, T. S., Skougaard, M., Strand, V., Mease, P. J., Kristensen, L. E., ... Tarp, S. (2018). Trial Characteristics as Contextual Factors When Evaluating Targeted Therapies in Patients With Psoriatic Disease: A Meta-Epidemiologic Study. Arthritis Care & Research, 70(8), 1206-1217. https://doi.org/10.1002/acr.23455
Ballegaard, Christine ; Jørgensen, Tanja S ; Skougaard, Marie ; Strand, Vibeke ; Mease, Philip J ; Kristensen, Lars E ; Dreyer, Lene ; Gottlieb, Alice ; de Wit, Maarten ; Christensen, Robin ; Tarp, Simon. / Trial Characteristics as Contextual Factors When Evaluating Targeted Therapies in Patients With Psoriatic Disease : A Meta-Epidemiologic Study. In: Arthritis Care & Research. 2018 ; Vol. 70, No. 8. pp. 1206-1217.
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abstract = "OBJECTIVE: To assess the importance of trial characteristics as contextual factors when evaluating the treatment effect of targeted therapies for patients with psoriatic disease.METHODS: We identified randomized controlled trials (RCTs) evaluating targeted therapies approved for psoriatic arthritis (PsA) and psoriasis (8 biologics and apremilast). The effect of targeted therapies was analyzed in the 2 psoriatic conditions combined by using drug retention as a common outcome, and separately by using the American College of Rheumatology 20{\%} improvement criteria (ACR20) for PsA and the Psoriasis Area Severity Index 75{\%} improvement score (PASI75) for psoriasis. We explored potential effect modification of trial characteristics in stratified and meta-regression analyses. Odds ratios (ORs) were calculated and compared among the trial eligibility criteria via the ratio of ORs.RESULTS: Forty-eight PsA and psoriasis trials (51 comparisons; 17,737 patients) were eligible. Overall retention was OR 2.16 (95{\%} confidence interval [95{\%} CI] 1.70-2.75) with higher odds for PsA trials compared with psoriasis trials (ratio of ORs 2.55 [95{\%} CI 1.64-3.97]). The eligibility criteria {"}targeted therapy history,{"} {"}minimum required disease duration,{"} {"}required negative rheumatoid factor,{"} and {"}required Classification Criteria for Psoriatic Arthritis criteria{"} were of importance for achieving ACR20 in PsA. The eligibility criterion {"}minimum required disease duration{"} was of importance for achieving PASI75 in psoriasis. A total of 7 PsA trials had rescue before time-point-of-retention reporting (adaptive trials).CONCLUSION: From this exploratory meta-epidemiologic study, we now have evidence from RCTs to support the notion that patients with PsA are more likely to adhere to targeted therapies compared to patients with psoriasis. Furthermore, we identified a few contextual factors of importance in regard to achieving ACR20 in PsA trials and PASI75 in psoriasis trials.",
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Ballegaard, C, Jørgensen, TS, Skougaard, M, Strand, V, Mease, PJ, Kristensen, LE, Dreyer, L, Gottlieb, A, de Wit, M, Christensen, R & Tarp, S 2018, 'Trial Characteristics as Contextual Factors When Evaluating Targeted Therapies in Patients With Psoriatic Disease: A Meta-Epidemiologic Study', Arthritis Care & Research, vol. 70, no. 8, pp. 1206-1217. https://doi.org/10.1002/acr.23455

Trial Characteristics as Contextual Factors When Evaluating Targeted Therapies in Patients With Psoriatic Disease : A Meta-Epidemiologic Study. / Ballegaard, Christine; Jørgensen, Tanja S; Skougaard, Marie; Strand, Vibeke; Mease, Philip J; Kristensen, Lars E; Dreyer, Lene; Gottlieb, Alice; de Wit, Maarten; Christensen, Robin; Tarp, Simon.

In: Arthritis Care & Research, Vol. 70, No. 8, 08.2018, p. 1206-1217.

Research output: Contribution to journalJournal articleResearchpeer-review

TY - JOUR

T1 - Trial Characteristics as Contextual Factors When Evaluating Targeted Therapies in Patients With Psoriatic Disease

T2 - A Meta-Epidemiologic Study

AU - Ballegaard, Christine

AU - Jørgensen, Tanja S

AU - Skougaard, Marie

AU - Strand, Vibeke

AU - Mease, Philip J

AU - Kristensen, Lars E

AU - Dreyer, Lene

AU - Gottlieb, Alice

AU - de Wit, Maarten

AU - Christensen, Robin

AU - Tarp, Simon

N1 - © 2017, American College of Rheumatology.

PY - 2018/8

Y1 - 2018/8

N2 - OBJECTIVE: To assess the importance of trial characteristics as contextual factors when evaluating the treatment effect of targeted therapies for patients with psoriatic disease.METHODS: We identified randomized controlled trials (RCTs) evaluating targeted therapies approved for psoriatic arthritis (PsA) and psoriasis (8 biologics and apremilast). The effect of targeted therapies was analyzed in the 2 psoriatic conditions combined by using drug retention as a common outcome, and separately by using the American College of Rheumatology 20% improvement criteria (ACR20) for PsA and the Psoriasis Area Severity Index 75% improvement score (PASI75) for psoriasis. We explored potential effect modification of trial characteristics in stratified and meta-regression analyses. Odds ratios (ORs) were calculated and compared among the trial eligibility criteria via the ratio of ORs.RESULTS: Forty-eight PsA and psoriasis trials (51 comparisons; 17,737 patients) were eligible. Overall retention was OR 2.16 (95% confidence interval [95% CI] 1.70-2.75) with higher odds for PsA trials compared with psoriasis trials (ratio of ORs 2.55 [95% CI 1.64-3.97]). The eligibility criteria "targeted therapy history," "minimum required disease duration," "required negative rheumatoid factor," and "required Classification Criteria for Psoriatic Arthritis criteria" were of importance for achieving ACR20 in PsA. The eligibility criterion "minimum required disease duration" was of importance for achieving PASI75 in psoriasis. A total of 7 PsA trials had rescue before time-point-of-retention reporting (adaptive trials).CONCLUSION: From this exploratory meta-epidemiologic study, we now have evidence from RCTs to support the notion that patients with PsA are more likely to adhere to targeted therapies compared to patients with psoriasis. Furthermore, we identified a few contextual factors of importance in regard to achieving ACR20 in PsA trials and PASI75 in psoriasis trials.

AB - OBJECTIVE: To assess the importance of trial characteristics as contextual factors when evaluating the treatment effect of targeted therapies for patients with psoriatic disease.METHODS: We identified randomized controlled trials (RCTs) evaluating targeted therapies approved for psoriatic arthritis (PsA) and psoriasis (8 biologics and apremilast). The effect of targeted therapies was analyzed in the 2 psoriatic conditions combined by using drug retention as a common outcome, and separately by using the American College of Rheumatology 20% improvement criteria (ACR20) for PsA and the Psoriasis Area Severity Index 75% improvement score (PASI75) for psoriasis. We explored potential effect modification of trial characteristics in stratified and meta-regression analyses. Odds ratios (ORs) were calculated and compared among the trial eligibility criteria via the ratio of ORs.RESULTS: Forty-eight PsA and psoriasis trials (51 comparisons; 17,737 patients) were eligible. Overall retention was OR 2.16 (95% confidence interval [95% CI] 1.70-2.75) with higher odds for PsA trials compared with psoriasis trials (ratio of ORs 2.55 [95% CI 1.64-3.97]). The eligibility criteria "targeted therapy history," "minimum required disease duration," "required negative rheumatoid factor," and "required Classification Criteria for Psoriatic Arthritis criteria" were of importance for achieving ACR20 in PsA. The eligibility criterion "minimum required disease duration" was of importance for achieving PASI75 in psoriasis. A total of 7 PsA trials had rescue before time-point-of-retention reporting (adaptive trials).CONCLUSION: From this exploratory meta-epidemiologic study, we now have evidence from RCTs to support the notion that patients with PsA are more likely to adhere to targeted therapies compared to patients with psoriasis. Furthermore, we identified a few contextual factors of importance in regard to achieving ACR20 in PsA trials and PASI75 in psoriasis trials.

U2 - 10.1002/acr.23455

DO - 10.1002/acr.23455

M3 - Journal article

C2 - 29073353

VL - 70

SP - 1206

EP - 1217

JO - Arthritis Care & Research

JF - Arthritis Care & Research

SN - 2151-464X

IS - 8

ER -