TY - JOUR
T1 - Network Meta-Analysis of Tofacitinib, Biologic Disease-Modifying Antirheumatic Drugs, and Apremilast for the Treatment of Psoriatic Arthritis
AU - Gladman, Dafna D.
AU - Orbai, Ana Maria
AU - Gomez-Reino, Juan
AU - Chang-Douglass, Stacey
AU - Leoncini, Emanuele
AU - Burton, Hannah E.
AU - Kanik, Keith S.
AU - Romero, Ana Belen
AU - Cappelleri, Joseph C.
AU - Hsu, Ming Ann
N1 - Funding Information:
Medical writing support, under the guidance of the authors, was provided by Simon Vass, PhD, CMC Connect, McCann Health Medical Communications, and Carole Evans, PhD, on behalf of CMC Connect, and was funded by Pfizer Inc, New York, New York, in accordance with Good Publication Practice guidelines.
Funding Information:
This study was sponsored by Pfizer Inc. Pfizer authors were involved in the conception and design of the study/analyses, as well as performing the data and statistical analyses. All authors were involved in data interpretation and manuscript drafting, reviewing, and final approval to submit. The views and opinions expressed within this manuscript are those of all authors and do not necessarily represent those of the sponsor.
Funding Information:
D. D. Gladman has received grant/research support from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, Pfizer Inc, and UCB; is a consultant for AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, Pfizer Inc, and UCB; and is a member of the speakers bureau for AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, Pfizer Inc, and UCB. A. M. Orbai has received research support from AbbVie, Celgene, Eli Lilly, Horizon, Janssen, Novartis, and Pfizer Inc and is a consultant for Celgene, Eli Lilly, Novartis, and Pfizer Inc. J. Gomez-Reino has received grant/research support from AbbVie, Novartis, Pfizer Inc, Roche, and UCB; is a consultant for Pfizer Inc; and is a member of the speakers bureau for AbbVie, Bristol-Myers Squibb, Janssen, MSD, Pfizer Inc, Roche, and UCB. S. Chang-Douglass was an employee of Decision Resources Group at the time of the analysis; during development of this publication, she started a role at the UK National Institute for Health and Care Excellence (NICE). The publication does not reflect the views of NICE. E. Leoncini and H. E. Burton are employees of Decision Resources Group. K. S. Kanik, A. B. Romero, J. C. Cappelleri, and M.-A. Hsu are employees and stockholders of Pfizer Inc. The authors have indicated that they have no other conflicts of interest regarding the content of this article.
PY - 2020
Y1 - 2020
N2 - Background: Tofacitinib and other new treatments approved for use in psoriatic arthritis have only recently been included in psoriatic arthritis treatment guidelines, and studies evaluating the relative efficacy of available therapies are important to inform treatment decisions by healthcare professionals. Objective: To perform a network meta-analysis to evaluate the efficacy and safety profiles of tofacitinib, biologic disease-modifying antirheumatic drugs (bDMARDs), and apremilast in patients with psoriatic arthritis naïve to tumor necrosis factor inhibitor therapy (TNFi-naïve) or with an inadequate response (TNFi-IR). Methods: A systematic literature review used searches of MEDLINE, Embase, and The Cochrane Library on October 9, 2017. Randomized controlled trials including adult patients with psoriatic arthritis receiving treatment administered as monotherapy or with conventional synthetic DMARDs were selected. Efficacy outcomes included American College of Rheumatology 20 response, change from baseline in Health Assessment Questionnaire-Disability Index, ≥75% improvement in Psoriasis Area and Severity Index, and change from baseline in Dactylitis Severity Score and Leeds Enthesitis Index. Treatment effects were evaluated during placebo-controlled phases, using a binomial logit model for binary outcomes and a normal identify link model for other outcomes. Discontinuations due to adverse events and serious infection events were assessed as safety outcomes. Results: The network meta-analysis included 24 published randomized controlled trials, of which 13 enrolled TNFi-naïve patients only, 3 enrolled TNFi-IR patients only, and 8 enrolled both TNFi-naïve and TNFi-IR patients. Placebo-controlled treatment durations ranged from 12 to 24 weeks. Indirect comparisons showed tofacitinib 5 and 10 mg BID to have similar efficacy compared with most bDMARDs and apremilast in improving joint symptoms (based on American College of Rheumatology 20 response), and with some bDMARDs in improving skin symptoms (based on Psoriasis Area and Severity Index) (tofacitinib 10 mg BID only in TNFi-IR) in patients with psoriatic arthritis who were TNFi-naïve or TNFi-IR. Results also showed that, compared with placebo, the improvement in physical functioning (based on Health Assessment Questionnaire-Disability Index) with tofacitinib 5 and 10 mg BID was similar to that observed with most bDMARDs and apremilast in TNFi-naïve patients, and similar to that observed with all bDMARDs with available data in the TNFi-IR population. Improvements in Dactylitis Severity Score and Leeds Enthesitis Index scores were comparable between treatments. Tofacitinib 5 and 10 mg BID were median-ranked 8 and 15, respectively, for discontinuation due to any adverse events, and 5 and 16, respectively, for a serious infection event out of a total of 20 treatments in the network (lower numbers are more favorable). Conclusions: Tofacitinib provides an additional treatment option for patients with psoriatic arthritis, both in patients naïve to TNFi and in those with TNFi-IR. (Curr Ther Res Clin Exp. 2020; 81:XXX–XXX)
AB - Background: Tofacitinib and other new treatments approved for use in psoriatic arthritis have only recently been included in psoriatic arthritis treatment guidelines, and studies evaluating the relative efficacy of available therapies are important to inform treatment decisions by healthcare professionals. Objective: To perform a network meta-analysis to evaluate the efficacy and safety profiles of tofacitinib, biologic disease-modifying antirheumatic drugs (bDMARDs), and apremilast in patients with psoriatic arthritis naïve to tumor necrosis factor inhibitor therapy (TNFi-naïve) or with an inadequate response (TNFi-IR). Methods: A systematic literature review used searches of MEDLINE, Embase, and The Cochrane Library on October 9, 2017. Randomized controlled trials including adult patients with psoriatic arthritis receiving treatment administered as monotherapy or with conventional synthetic DMARDs were selected. Efficacy outcomes included American College of Rheumatology 20 response, change from baseline in Health Assessment Questionnaire-Disability Index, ≥75% improvement in Psoriasis Area and Severity Index, and change from baseline in Dactylitis Severity Score and Leeds Enthesitis Index. Treatment effects were evaluated during placebo-controlled phases, using a binomial logit model for binary outcomes and a normal identify link model for other outcomes. Discontinuations due to adverse events and serious infection events were assessed as safety outcomes. Results: The network meta-analysis included 24 published randomized controlled trials, of which 13 enrolled TNFi-naïve patients only, 3 enrolled TNFi-IR patients only, and 8 enrolled both TNFi-naïve and TNFi-IR patients. Placebo-controlled treatment durations ranged from 12 to 24 weeks. Indirect comparisons showed tofacitinib 5 and 10 mg BID to have similar efficacy compared with most bDMARDs and apremilast in improving joint symptoms (based on American College of Rheumatology 20 response), and with some bDMARDs in improving skin symptoms (based on Psoriasis Area and Severity Index) (tofacitinib 10 mg BID only in TNFi-IR) in patients with psoriatic arthritis who were TNFi-naïve or TNFi-IR. Results also showed that, compared with placebo, the improvement in physical functioning (based on Health Assessment Questionnaire-Disability Index) with tofacitinib 5 and 10 mg BID was similar to that observed with most bDMARDs and apremilast in TNFi-naïve patients, and similar to that observed with all bDMARDs with available data in the TNFi-IR population. Improvements in Dactylitis Severity Score and Leeds Enthesitis Index scores were comparable between treatments. Tofacitinib 5 and 10 mg BID were median-ranked 8 and 15, respectively, for discontinuation due to any adverse events, and 5 and 16, respectively, for a serious infection event out of a total of 20 treatments in the network (lower numbers are more favorable). Conclusions: Tofacitinib provides an additional treatment option for patients with psoriatic arthritis, both in patients naïve to TNFi and in those with TNFi-IR. (Curr Ther Res Clin Exp. 2020; 81:XXX–XXX)
KW - Biologic disease-modifying antirheumatic drug
KW - Network meta-analysis
KW - Psoriatic arthritis
KW - TNFi-IR
KW - TNFi-naïve
KW - Tofacitinib
UR - http://www.scopus.com/inward/record.url?scp=85090425582&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85090425582&partnerID=8YFLogxK
U2 - 10.1016/j.curtheres.2020.100601
DO - 10.1016/j.curtheres.2020.100601
M3 - Article
C2 - 32983284
AN - SCOPUS:85090425582
VL - 93
JO - Current Therapeutic Research
JF - Current Therapeutic Research
SN - 0011-393X
M1 - 100601
ER -