TY - JOUR

T1 - Effect of nurse-led care on outcomes in patients with ACPA/RF-positive rheumatoid arthritis with active disease undergoing treat-to-target

T2 - A multicentre randomised controlled trial

AU - Hoeper, Juliana Rachel

AU - Zeidler, Jan

AU - Meyer, Sara Eileen

AU - Gauler, Georg

AU - Steffens-Korbanka, Patricia

AU - Welcker, Martin

AU - Wendler, Jörg

AU - Schuch, Florian

AU - Von Hinüber, Ulrich

AU - Schwarting, Andreas

AU - Witte, Torsten

AU - Meyer-Olson, Dirk

AU - Hoeper, Kirsten

N1 - Funding Information: Competing interests JH, JZ, SEM, TW and UvH: none declared; GG has undertaken consultancies and speakers’ bureau for Abbvie, Lilly, Gilead, Celgene and Novartis; PSK has undertaken consultancies and speakers’ bureau for Abbvie, Chugai, Novartis, Sanofi, Mylan and Lilly. MW has undertaken consultancies and speakers’ bureau for Abbvie, Actelion, Aescu, Amgen, Biogen, BMS, Berlin Chemie, Celgene, Gilead, GSK, Hexal, Janssen, Medac, MSD, Mundipharma, Mylan, Novartis, Pfizer, Riemser, Roche, Sanofi, SOBI and UCB. JW has undertaken consultancies and speakers’ bureau for Janssen, Abbvie, Roche, Chugai and Novartis. FS has undertaken consultancies and speakers’ bureau for Novartis, Abbvie and Gilead. AS has received grants from Pfizer, GSK and Novartis, and has undertaken consultancies and speakers’ bureau for GSK and Roche. DMO has received grants from Novartis and Sandoz Hexal and has undertaken consultancies and speakers’ bureau for Abbvie, Amgen, BMS, Chugai, Lilly, Mylan, Novartis, Pfizer, Sandoz Hexal and Sanofi. KH has undertaken consultancies and speakers’ bureau for Abbvie, Chugai, Novartis, Lilly, Celgene, UCB, Sandoz Hexal, Sanofi and Gilead. Funding Information: Funding The study was conducted as a subproject of the 'Rheuma-VOR' project and received funding from the Federal Joint Committee (G-BA). Funding number: 01NVF16029.

PY - 2021/4/16

Y1 - 2021/4/16

N2 - Objective To determine the non-inferiority of nurse-led care (NLC) in patients with anticitrullinated protein antibody (ACPA)-positive and/or rheumatoid factor (RF)-positive rheumatoid arthritis (RA) with active disease who are starting disease-modifying antirheumatic drug therapy, following treat-to-target (T2T) recommendations. Methods A multicentre, pragmatic randomised controlled trial was conducted to assess clinical effectiveness, anxiety, depression and patient satisfaction following a non-inferiority design. The participants were 224 adults with ACPA/RF-positive RA who were randomly assigned to either NLC or rheumatologist-led care (RLC). The primary outcome was the Disease Activity Score in 28 Joints measured with C reactive protein (DAS28-CRP) assessed at baseline and after 3, 6, 9 and 12 months. A DAS28-CRP difference of 0.6 was set as the non-inferiority margin. Mean differences between the groups were assessed following per-protocol and intention-to-treat strategies. Results Demographic data and baseline characteristics of patients in the NLC group (n=111) were comparable to those of patients in the RLC group (n=113). The improvement in disease activity (change in DAS28-CRP, primary outcome) over the course of 12 months was significant in both groups (p<0.001). No significant differences were observed between the NLC and RLC groups (p=0.317). Non-inferiority of NLC was shown for the primary outcome and all secondary outcomes. Conclusion This study supported the non-inferiority of NLC in managing T2T and follow-up care of patients with RA with moderate to high disease activity and poor prognostic factors in addition to RLC. Trial registration number DRKS00013055.

AB - Objective To determine the non-inferiority of nurse-led care (NLC) in patients with anticitrullinated protein antibody (ACPA)-positive and/or rheumatoid factor (RF)-positive rheumatoid arthritis (RA) with active disease who are starting disease-modifying antirheumatic drug therapy, following treat-to-target (T2T) recommendations. Methods A multicentre, pragmatic randomised controlled trial was conducted to assess clinical effectiveness, anxiety, depression and patient satisfaction following a non-inferiority design. The participants were 224 adults with ACPA/RF-positive RA who were randomly assigned to either NLC or rheumatologist-led care (RLC). The primary outcome was the Disease Activity Score in 28 Joints measured with C reactive protein (DAS28-CRP) assessed at baseline and after 3, 6, 9 and 12 months. A DAS28-CRP difference of 0.6 was set as the non-inferiority margin. Mean differences between the groups were assessed following per-protocol and intention-to-treat strategies. Results Demographic data and baseline characteristics of patients in the NLC group (n=111) were comparable to those of patients in the RLC group (n=113). The improvement in disease activity (change in DAS28-CRP, primary outcome) over the course of 12 months was significant in both groups (p<0.001). No significant differences were observed between the NLC and RLC groups (p=0.317). Non-inferiority of NLC was shown for the primary outcome and all secondary outcomes. Conclusion This study supported the non-inferiority of NLC in managing T2T and follow-up care of patients with RA with moderate to high disease activity and poor prognostic factors in addition to RLC. Trial registration number DRKS00013055.

KW - health services research

KW - nursing

KW - outcomes research

KW - rheumatoid arthritis

UR - http://www.scopus.com/inward/record.url?scp=85104363185&partnerID=8YFLogxK

U2 - 10.1136/rmdopen-2021-001627

DO - 10.1136/rmdopen-2021-001627

M3 - Article

C2 - 33863842

AN - SCOPUS:85104363185

VL - 7

JO - RMD Open

JF - RMD Open

SN - 2056-5933

IS - 1

M1 - e001627

ER -