ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2873

Pharmacological Treatment of Psoriatic Arthritis (PSA): Systematic Literature Review for the Update of the EULAR Recommendations for the Management of PSA

Sofia Ramiro1, Josef S. Smolen2, Robert B.M. Landewé3, Désirée van der Heijde1, Maxime Dougados4, Paul Emery5, Maarten de Wit6, Maurizio Cutolo7, Susan Oliver8 and Laure Gossec9, 1Rheumatology, Leiden University Medical Center, Leiden, Netherlands, 2Department of Rheumatology, Medical University of Vienna, Vienna, Austria, 3Department of Rheumatology, Amsterdam Rheumatology Center, Amsterdam, Netherlands, 4Rheumatology Department, Cochin hospital, Paris-Descartes University, Paris, France, 5Section of Musculoskeletal Disease, Leeds Institute of Molecular Medicine, University of Leeds, Leeds, United Kingdom, 6EULAR Social Leagues, Zurich, Switzerland, 7Division of Clinical Immunology, Dept Internal Medicine, University of Genova, Genova, Italy, 8Independent Nurse Consultant, North Devon, United Kingdom, 9Rheumatology, Pitié Salpetriere Hospital, Paris, France

Meeting: 2015 ACR/ARHP Annual Meeting

Date of first publication: September 29, 2015

Keywords: , ,

Session Information

Date: Tuesday, November 10, 2015

Title: Spondylarthropathies and Psoriatic Arthritis - Clinical Aspects and Treatment Poster III: Therapy

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose: As part of the update of the EULAR recommendations for the management of PsA, we performed a systematic literature review to assess the efficacy and safety of pharmacological agents for the management of PsA.

Methods: Randomised controlled trials (RCTs), including long-term extensions, comparing any two pharmacological interventions for the management of patients with PsA, were identified by searches in Medline, Embase and Cochrane datasets (2010-2014), supplemented by searches in 2013-2014 EULAR and ACR abstracts. Pharmacological interventions were defined as any biological (bDMARD), synthetic DMARD (sDMARD) either conventional or targeted, NSAID, glucocorticoid or any combination and they could be compared to any of them or placebo (PBO). Strategy trials were also included. The main efficacy outcomes were ACR20, ACR50, PASI75 and radiographic progression, and the main safety outcome was withdrawals due to adverse events. Risk of bias (RoB) was assessed according to the Cochrane tool. Multiple studies of the same intervention were meta-analysed with random effects analysis in RevMan.

Results: Of 2,278 articles and 387 conference abstracts screened, 42 (24 papers and 18 abstracts) met the inclusion criteria. A total of 19 articles/abstracts focused on 3 new drugs for the management of PsA: ustekinumab (UST), apremilast (APR) and secukinumab (SEC). All were PBO-compared trials and met their primary endpoint, ACR20; RoB was low (UST, SEC) or unclear (APR). For achieving ACR20, absolute responses are in the Table. Risk ratios (RR) versus PBO were respectively for UST90mg and UST45mg of 2.17 (95%CI 1.71-2.76) and 1.95 (1.52-2.50); for APR30mg and APR20mg of 2.06 (1.67, 2.54) and 1.84 (1.51-2.25); and for SEC300mg, SEC150mg and SEC75mg, of 3.31 (2.04-5.36), 5.82 (1.56-21.71) and 4.47 (0.66-30.26). The 3 drugs showed efficacy on dactylitis and enthesitis, with APR apparently showing less pronounced effects. These new drugs showed slightly more SAEs and withdrawals due to AEs than PBO. Eleven articles/abstracts on golimumab and certolizumab pegol demonstrated the efficacy and safety of these drugs with respect to all outcomes. A strategy trial, TICOPA, has shown better ACR responses with tight control compared to standard care. No studies were found on NSAIDs or glucocorticoids.

Table – Main efficacy outcomes of the new drugs for the treatment of PsA, at time point of the trial’s primary endpoint

Trial, time point

Treatment arm

ACR 20 (%)

ACR 50 (%)

PASI 75 (%)

delta mTSS

PSUMMIT 1

24 Weeks

UST 90mg

49.5

27.9

62.4

0.4 (2.4)*

UST 45mg

42.4

24.9

57.2

0.4 (2.1)*

PBO

22.8

8.7

11.0

1.0 (3.9)*

PSUMMIT 2

24 Weeks

UST 90mg

43.8

22.9

55.6

**

UST 45mg

43.7

17.5

51.3

**

PBO

20.2

6.7

5.0

**

PALACE 1

16 Weeks

APR 30mg

38.1

NA

NA

NA

APR 20mg

30.4

NA

NA

NA

PBO

19.0

NA

NA

NA

PALACE 2

16 Weeks

APR 30mg

34.4

NA

NA

NA

APR 20mg

38.4

NA

NA

NA

PBO

19.5

NA

NA

NA

PALACE 3

16 Weeks

APR 30mg

42.8

NA

NA

NA

APR 20mg

29.4

NA

NA

NA

PBO

18.9

NA

NA

NA

PALACE 4

16 Weeks

APR 30mg

29.2

NA

NA

NA

APR 20mg

32.3

NA

NA

NA

PBO

16.9

NA

NA

NA

FUTURE 1

24 Weeks

SEC 150mg

50.0

34.7

61.1

0.13

SEC 75mg

50.5

30.7

64.8

0.02

PBO

17.3

7.4

8.3

0.57

FUTURE 2

24 Weeks

SEC 300mg

54.0

35.0

63.4

NA

SEC 150mg

51.0

35.0

48.3

NA

SEC 75mg

29.3

18.2

28.9

NA

PBO

15.3

7.1

16.3

NA

*Results reflect a pooled analysis of PSUMMIT 1 and 2, as a priori pre-defined

Conclusion:

UST, APR and SEC are new drugs with efficacy demonstrated for the treatment of PsA. No major safety signals arise, but long-term studies are needed. Studies with new TNFi confirm the efficacy of these drugs. Treatment set to a therapeutic target achieves better outcome than non-targeted therapy. This review informs the update of the EULAR recommendations for the management of PsA.

Disclosure: S. Ramiro, None; J. S. Smolen, Consultant for: AbbVie Inc., Amgen, AstraZeneca, Astro, BMS, Celgene, Centocor-Janssen, Glaxo, Lilly, Pfizer, MSD, Novo-Nordisk, Roche, Samsung, Sandoz, and UCB, 5; R. B. M. Landewé, Consultant for: AbbVie, Amgen, AstraZeneca, Augurex, BMS, Boehringer Ingelheim, Celgene, Centocor, Chugai, Covagen, Daiichi, Eli-Lilly, Galapagos, GSK, Janssen Biologics, Merck, Novartis, Novo-Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, UCB, Vertex Di, 5; D. van der Heijde, Consultant for: AbbVie, Amgen, AstraZeneca, Augurex, BMS, Boehringer Ingelheim, Celgene, Centocor, Chugai, Covagen, Daiichi, Eli-Lilly, Galapagos, GSK, Janssen Biologics, Merck, Novartis, Novo-Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, UCB, Vertex Di, 5; M. Dougados, Consultant for: AbbVie, Pfizer, UCB, Novartis, Sanofi, Lilly, Merck, BMS, 5; P. Emery, Abbvie, Pfizer, MSD, UCB, Roche, Novartis, BMS, 5; M. de Wit, Consultant for: AbbVie, BMS, Celgene, Eli-Lilly, Novartis, Roche, 5; M. Cutolo, Consultant for: BMS, Actelion, Celgene, Celltrion, Horizon, Mundipharm, 5; S. Oliver, Consultant for: AbbVie, MSD, Pfizer, Regeneron, Roche and UCB, 5; L. Gossec, Consultant for: Abbvie, Amgen, Celgene, Chugai, Janssen, MSD, Novartis, Pfizer, Regeneron, Roche and UCB, 5.

To cite this abstract in AMA style:

Ramiro S, Smolen JS, Landewé RBM, van der Heijde D, Dougados M, Emery P, de Wit M, Cutolo M, Oliver S, Gossec L. Pharmacological Treatment of Psoriatic Arthritis (PSA): Systematic Literature Review for the Update of the EULAR Recommendations for the Management of PSA [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/pharmacological-treatment-of-psoriatic-arthritis-psa-systematic-literature-review-for-the-update-of-the-eular-recommendations-for-the-management-of-psa/. Accessed .

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