Radiographic Progression of Patients With Psoriatic Arthritis Who Achieve Minimal Disease Activity in Response to Golimumab Therapy: Results Through 5 Years of a Randomized, Placebo‐Controlled Study

Abstract

ObjectiveTo evaluate long‐term outcomes in psoriatic arthritis (PsA) patients who achieved or did not achieve minimal disease activity (MDA) through 5 years of golimumab treatment in the GO‐REVEAL trial.MethodsThe GO‐REVEAL trial was a phase III, randomized, double‐blind trial with placebo‐control through week 24 followed by an open‐label extension of golimumab 50/100 mg treatment up to 5 years. In these post‐hoc analyses, MDA was defined by the presence of ≥5 of 7 PsA outcome measures (≤1 swollen joint, ≤1 tender joint, Psoriasis Area and Severity Index [PASI] ≤1, patient pain score ≤15, patient global disease activity score ≤20 [range 0–100], Health Assessment Questionnaire disability index [HAQ DI] ≤0.5, and ≤1 tender enthesis point).ResultsTreatment with golimumab yielded significantly higher MDA response rates versus patients randomized to placebo at week 14 (23.5% versus 1.0%; P < 0.0001), week 24 (28.1% versus 7.7%; P < 0.0001), and week 52 (42.4% versus 30.2%; P = 0.037). MDA was achieved at least once by ∼50% of golimumab‐treated patients overall. Irrespective of treatment randomization, achievement of MDA at ≥3 and ≥4 consecutive visits was associated with significantly less radiographic progression and more improvement in MDA components allowing specific assessment of physical function (HAQ DI) and overall disease activity (patient global assessment of disease activity) at week 256 versus patients not achieving MDA. Logistic regression analyses indicated that a 1‐unit higher baseline HAQ DI score yielded a significantly lower likelihood of achieving MDA at ≥3 (odds ratio 0.514 [95% confidence interval 0.321–0.824]; P = 0.006) and ≥4 (odds ratio 0.480 [95% confidence interval 0.290–0.795]; P = 0.004) consecutive visits.ConclusionAmong golimumab‐treated PsA patients, better long‐term functional improvement, patient global assessment, and radiographic outcomes were observed when patients achieved persistent MDA.

Minimal Disease Activity as a Treatment Target in Psoriatic Arthritis: A Review of the Literature

“…Further, in a randomized controlled study with GOL, the 36% of patients who had MDA for ≥ 3 consecutive visits had significantly less radiographic progression compared with patients who did not reach MDA at 5 years 18 . Patients also experienced greater longterm functional improvements and improved patient global assessment of disease activity when they attained persistent MDA 5 .…”

“…MDA has been assessed in several trials with biologic DMARD in PsA, including trials with TNF inhibitors, and more recently, the IL-17A inhibitor, secukinumab 15,16,17,18,19,20 . TNF inhibitor therapy.…”

“…TNF inhibitor therapy. Across the randomized controlled trials with TNF inhibitors, the proportion of patients achieving MDA is variable (24-52%, Table 1) 15,16,17,18 . It is noteworthy that about 45-56% of patients in the randomized controlled studies with TNF inhibitors, including those receiving placebo, were receiving MTX and the vast majority of patients were naive to previous biologic therapy.…”

“…It is noteworthy that about 45-56% of patients in the randomized controlled studies with TNF inhibitors, including those receiving placebo, were receiving MTX and the vast majority of patients were naive to previous biologic therapy. Longterm data from these trials indicate that MDA response rates were sustained in patients who continued the therapy (Table 2) 15,18,21,22,23 . Secukinumab.…”

“…As alluded to previously, further longterm data assessing the relevance of MDA are also required. The prognostic relevance of MDA through 5 years has been assessed with GOL in a clinical trial setting 18 , but more data are required with greater numbers of patients treated with additional agents and in a real-world setting. Exactly what MDA and other composite outcomes are measuring, and to what degree reversible inflammatory disease is being evaluated, remains to be determined.…”