Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

NYU Langone Health

Status and phase: Not yet enrolling; Phase 2

Conditions: Rheumatic Disease

Treatments: Drug: Cyclosporine; Drug: Infliximab; Drug: Tacrolimus; Biological: Bimekizumab; Biological: Secukinumab; Biological: Canakinumab; Drug: Adalimumab; Biological: Abatacept; Drug: Certolizumab; Biological: Rituximab; Drug: Tofacitinib; Biological: Risankizumab; Drug: Mycophenolate; Biological: Ustekinumab; Drug: Azathioprine; Drug: Hydroxychloroquine; Drug: Upadacitinib; Drug: Sulfasalazine; Biological: Ixekizumab; Drug: Methotrexate; Drug: Golimumab; Biological: Anakinra; Biological: Tocilizumab; Biological: Guselkumab; Drug: Leflunomide; Biological: Belimumab; Drug: Etanercept

Study type: Interventional

Funder types: Other

Identifiers

NCT07138898

25-00380

Details and patient eligibility

About

The purpose of this study is to assess the incidence of rheumatologic flares, changes in pain scores (VAS), changes in functional outcomes (PROMIS), wound complications, surgical site infections, and return trips to the operating room for rheumatology patients following shoulder replacements, comparing those who stop their immunosuppressants preoperatively for the same amount of time as suggested in the literature for hip and knee arthroplasty versus those who hold the medications for a shorter period of time preoperatively.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults aged 18 years and older at the time of informed consent;
2. Diagnosis of rheumatic disease: rheumatoid arthritis (RA), psoriatic arthritis (PA) , ankylosing spondylitis (AS), systemic lupus erythematosus (SLE), juvenile idiopathic arthritis (JIA), spondyloarthritis, polymyalgia rheumatica, giant cell arteritis, vasculitis, granulomatosis with polyangiitis, dermatomyositis, polymyositis, and inflammatory bowel disease-associated arthritis;
3. On active immunosuppression for at least 3 months prior to scheduled surgery;
4. Scheduled for elective total shoulder arthroplasty;
5. Able and willing to provide written informed consent prior to any study specific procedures.

Exclusion criteria

• Patients with active infections or malignancies;
• Patients undergoing shoulder arthroplasty for fracture or tumor;
• Pregnancy or breastfeeding;
• Unable to provide informed consent;
• Patients with severe SLE with marked activity - as they should be offered enrollment in the observational arm. All such patients should remain on treatment to avoid worsening of disease activity;
• Unable or without capacity to provide written informed consent prior to any study specific procedures.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Standard hold

Active Comparator group

Description:

Patients will follow the standard perioperative immunosuppressant hold protocol based on guidelines from hip and knee arthroplasty literature. The duration of the hold is determined by medication half-life and infection risk considerations. Postoperatively, medications will be restarted approximately 2 weeks after surgery (+/- 2 days), contingent on wound healing and infection status.

Treatment:

Drug: Etanercept

Biological: Belimumab

Drug: Leflunomide

Biological: Guselkumab

Biological: Tocilizumab

Biological: Anakinra

Drug: Golimumab

Drug: Methotrexate

Biological: Ixekizumab

Drug: Sulfasalazine

Drug: Upadacitinib

Drug: Hydroxychloroquine

Drug: Azathioprine

Biological: Ustekinumab

Drug: Mycophenolate

Drug: Tofacitinib

Biological: Risankizumab

Biological: Rituximab

Drug: Certolizumab

Biological: Abatacept

Drug: Adalimumab

Biological: Canakinumab

Biological: Secukinumab

Biological: Bimekizumab

Drug: Tacrolimus

Drug: Infliximab

Drug: Cyclosporine

Shorter hold

Experimental group

Description:

Patients will follow an abbreviated immunosuppressant hold protocol, withhold durations modified based on drug pharmacokinetics to allow a shorter preoperative discontinuation period. Medications will be prescribed as usual by the patient's rheumatologist, only adjusting the interval between last preoperative dose and surgery. The rheumatologist will relay the number of weeks/days between the last dose and surgery date. Postoperatively, medications will be restarted approximately 1 week after surgery (+/- 2 days), provided there are no signs of infection or wound healing complications. Route of Administration

Treatment:

Drug: Etanercept

Biological: Belimumab

Drug: Leflunomide

Biological: Guselkumab

Biological: Tocilizumab

Biological: Anakinra

Drug: Golimumab

Drug: Methotrexate

Biological: Ixekizumab

Drug: Sulfasalazine

Drug: Upadacitinib

Drug: Hydroxychloroquine

Drug: Azathioprine

Biological: Ustekinumab

Drug: Mycophenolate

Drug: Tofacitinib

Biological: Risankizumab

Biological: Rituximab

Drug: Certolizumab

Biological: Abatacept

Drug: Adalimumab

Biological: Canakinumab

Biological: Secukinumab

Biological: Bimekizumab

Drug: Tacrolimus

Drug: Infliximab

Drug: Cyclosporine