Background/Purpose:  Randomized controlled trials in psoriatic arthrtitis (PsA) have allowed treatment with TNF inhibitors (TNFi) as monotherapy as well as co-medication with methotrexate (MTX), but no trials have indicated any difference in response to TNFi in subgroups with and without concomitant MTX.¹ Current PsA treatment guidelines do not provide clear recommendations on the use of TNFi as monotherapy or combined with MTX.^2-4  Recent real-life data found no additional benefit in response but a trend towards better drug survival in patients receiving TNFi and concomitant MTX.^5,6 We pooled data (post-hoc) from two clinical trials^7,8 to evaluate clinical and functional outcomes in PsA patients receiving etanercept (ETN) with and without MTX.

Methods:  Data from PsA patients with active disease receiving ETN (25 mg twice weekly⁷ or 50 mg once weekly⁸) with (ETN+MTX arm) and without MTX (ETN arm) were included in descriptive summaries. Demographic and disease activity characteristics at baseline, PsARC and ACR20, 50, and 70 responses at 24 weeks, and change from baseline to week 24 in DAS28-CRP, HAQ-DI, and PASI were summarized for patients in the ETN arm and in ETN+MTX arm across both studies.

Results:  At baseline, patients in the ETN (n=322) and ETN+MTX (n=153) arms had a mean age (SD) of 47.0 (11.7) and 47.3 (11.1) years, respectively; weight of 84.7 kg (18.7) and 87.1 (20.6); 38% and 42% were female. The duration of psoriasis was 18.4 (12.0) and 17.5 (11.0) years, respectively; duration of PsA, 8.2 (7.8) and 8.9 (7.0) years; DAS28-CRP, 4.7 (1.2) and 4.7 (1.1); HAQ-DI, 0.9 (0.7) and 1.1 (0.7); and PASI, 18.3 (10.2) and 16.1 (9.6). Other demographic and baseline disease characteristics were also similar for patients in the ETN arm and ETN+MTX arms. Similar proportions of patients in both arms achieved PsARC and ACR20 responses; numerically, a higher proportion of patients in the ETN arm achieved ACR50 and ACR70 responses than in the combination therapy arm. Little difference between groups was observed in DAS28-CRP, HAQ-DI, and PASI improvement from baseline (Table).

 

Table. Clinical and functional outcomes in patients in the ETN and ETN + MTX arms across studies7,8
	ETN Arm	ETN+MTX Arm
% patients achieving endpoint at week 24 (n/N)
PsARC	80.3 (240/299)	82.6 (119/144)
ACR20	70.5 (203/288)	69.9 (100/143)
ACR50	54.9 (158/288)	48.3 (69/143)
ACR70	34.7 (100/288)	26.6 (38/143)
Change from baseline to week 24, mean (SD)
DAS28-CRP	-1.9 (1.3)	-1.8 (1.1)
HAQ-DI	-0.5 (0.6)	-0.6 (0.6)
PASI	-13.6 (9.6)	-12.2 (9.5)
PsARC, Psoriatic Arthritis Response Criteria; ACR20/50/70, American College of Rheumatology 20%, 50%,and 70% improvement; DAS28, Disease Activity Score based on 28-joint count using C-reactive protein; HAQ-DI, Health Assessment Questionnaire-Disability Index; PASI, Psoriasis Area and Severity Index

Conclusion:  Etanercept with or without MTX combination therapy provided similar benefit across clinical and functional outcomes in patients with active PsA at 24 weeks of treatment. Further research is warranted to investigate the effect of concomitant MTX on responses and drug survival in patients with PsA starting their first TNFi.

References: 1. Ash Z, et al. Ann Rheum Dis 2012;71:319-26. 2. Mumtaz A, et al. Curr Rheumatol Rep 2010;12:264-71. 3. Braun J, et al. Ann Rheum Dis 2011;70:896-904. 4. Gossec L, et al. Ann Rheum Dis 2012;71:4-12. 5. Kristensen LE, et al. Ann Rheum Dis 2008;67:364-9. 6. Fagerli KM, et al. Ann Rheum Dis 2013 Jan 3 [epub ahead of print]. 7. Mease P, et al. Arthritis Rheum 2004;50:2264-72. 8. Sterry W, et al. BMJ 2010 Feb 2;340.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/response-to-etanercept-with-or-without-methotrexate-combination-therapy-in-patients-with-psoriatic-arthritis/