Background In rheumatoid arthritis (RA) patients (pts) receiving corticosteroids (CS) or methotrexate (MTX) with an anti-TNF, such as adalimumab (ADA), the concomitant CS or MTX dose may be reduced if pts respond well or have side-effects.
Objectives To assess treatment effectiveness in pts whose MTX or CS oral dose was reduced over 10 years (y) of open label (OL) ADA treatment.
Methods This was observed data from OL extensions (OLE) of the PREMIER and DE019 trials.1,2 In PREMIER, MTX-naïve, early RA pts received ADA/MTX/ADA+MTX for 2y, and optional OL ADA for upto 8y. In DE019, biologic-naïve, established RA pts received 20 mg ADA+MTX/ 40 mg ADA+MTX/PBO+MTX for 1y and optional OL ADA+MTX for upto 9y. In both OLEs, MTX could be added/adjusted at the investigator's discretion, and oral CS dose could be tapered in pts who responded. Effectiveness at final visit (FV) was assessed by the numbers of pts achieving TJC68 =0, SJC66 =0, improvement from baseline in HAQ-DI ≥0.5 (HAQ-DI 0.5), ACR20/50/70 criteria and 28-joint disease activity score based on C-reactive protein (DAS28-CRP)<2.6. Additionally, in PREMIER, modified EULAR remission (REM) criteria [DAS28-CRP <2.6, TJC68 ≤1, SJC66 ≤1], “Good EULAR response” [DAS28-CRP <3.2 with a change from baseline ≤-1.2] were used.
Results In PREMIER, by the pt's FV, out of 375 pts who had any oral CS, 220 (58.7%) were on ongoing CS; 155 (41.3%) had stopped. Among the 375 pts, 32% had a stable CS dose and 26.1% had a CS dose reduction. Dose reduction did not affect the proportion of pts reaching ACR criteria, HAQ-DI 0.5, and DAS28-CRP <2.6 by FV (table). Out of 497 pts in the OLE, 261 (52.5%) used concomitant MTX in the OLE, 236 pts did not. With/without MTX, the number of pts with DAS28-CRP<2.6 increased from 2 to 10y, and the proportion of pts with SJC or TJC=0, good EULAR response, or modified EULAR REM criteria, and the HAQ-DI scores were comparable in the +/− MTX groups. In DE019, by the pt's FV, out of 352 pts who received any oral CS, 207 (58.8%) were on ongoing CS and 145 (41.2%) had stopped CS. Among the 352 pts, 141 (40%) had a stable CS dose and 82 pts (23.3%) had a dose reduction. Out of 550 pts on MTX during the study, 497 (90.4%) were receiving MTX, and 53 (9.6%) had stopped by FV; 345/550 pts (62.7%) had stable MTX and 158 (28.7%) had a reduction. Reduction of CS or MTX did not affect the proportion of pts who reached the ACR criteria, HAQ-DI 0.5 and DAS28-CRP <2.6 by FV.
Conclusions Overall, effectiveness associated with continuous ADA treatment was not sacrificed in pts in whom concomitant oral CS or/and MTX doses were reduced or discontinued, although many of these pts were likely responding well at the time of taper.
Keystone et al. J Rheum 2013;40:1487–97;
Keystone et al. J Rheum, 2014;41:5–14
Acknowledgement AbbVie: study sponsor, contributed to design, data collection, analysis, interpretation; in writing, reviewing and approval of final version. Medical writing support: Naina Barretto of AbbVie.
Disclosure of Interest E. Keystone Grant/research support from: AbbVie, Amgen, AstraZeneca, BMS, Janssen, Pfizer, Roche, and UCB, Consultant for: AbbVie, Amgen, AstraZeneca, BMS, Janssen, Pfizer, Roche, and UCB, Speakers bureau: AbbVie, Amgen, AstraZeneca, BMS, Janssen, Pfizer, Roche, and UCB, F. Breedveld Consultant for: Centocor, Schering-Plough, Amgen/Wyeth, and AbbVie, A. Kavanaugh Grant/research support from: AbbVie, Amgen, AstraZeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, and UCB, Consultant for: AbbVie, Amgen, AstraZeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, and UCB, Y. Zhang Shareholder of: AbbVie, Employee of: AbbVie, I. Sainsbury Shareholder of: AbbVie, Employee of: AbbVie, J. Kalabic Shareholder of: AbbVie, Employee of: AbbVie
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