Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

• Methotrexate (Drug): Continue throughout perioperative period
• Sulfasalazine (Drug): Continue throughout perioperative period
• Hydroxychloroquine (Drug), also known as Plaquenil: Continue throughout perioperative period
• Leflunomide (Drug), also known as Arava: Continue throughout perioperative period
• Azathioprine (Drug), also known as Imuran: Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery
• Mycophenolate (Drug), also known as Cellcept: Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery
• Cyclosporine (Drug): Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery
• Tacrolimus (Drug): Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery
• Etanercept (Drug), also known as Enbrel: Control group: Schedule surgery 2 weeks after last administered dose Intervention group: Schedule surgery 1 week after last administered dose
• Adalimumab (Drug), also known as Humira: Control group: Schedule surgery 3 weeks after last administered dose Intervention group: Schedule surgery 1 week after last administered dose
• Golimumab (Drug), also known as Simponi: Control group: Schedule surgery 5 weeks after last administered 4-week subcutaneous dose or 9 weeks after last administered 8-week intravenous dose. Intervention group: Schedule surgery 2 weeks after last administered 4-week subcutaneous dose or 4 weeks after last administered 8-week intravenous dose.
• Certolizumab (Drug), also known as Cimzia: Control group: Schedule surgery 5 weeks after last administered dose. Intervention group: Schedule surgery 2 weeks after last administered dose.
• Infliximab (Drug), also known as Remicaide: Control group: Schedule surgery 9 weeks after last administered intravenous dose. Intervention group: Schedule surgery 4 weeks after last administered dose.
• Rituximab (Biological), also known as Rituxan: Control: Schedule 7 months after last administered dose. Intervention group: Schedule 3 months after last administered dose.
• Belimumab (Biological), also known as Benlysta: Control group: Schedule surgery 2 weeks after last administered subcutaneous weekly dose or 5 weeks after last administered 4-week intravenous dose. Intervention group: Schedule surgery 1 week after last administered weekly dose or 2 weeks after last administered 4-week dose.
• Tocilizumab (Biological), also known as Actemra: Control group: Schedule surgery 2 weeks after last administered subcutaneous weekly dose or 5 weeks after last administered 4-week intravenous dose. Intervention group: Schedule surgery 1 week after last administered weekly dose or 2 weeks after last administered 4-week dose.
• Anakinra (Biological), also known as Kineret: Control group: Schedule surgery 2 days after last administered daily dose. Experimental group: Schedule surgery 1 day after last administered daily dose.
• Canakinumab (Biological), also known as Ilaris: Control group: Schedule surgery 5 weeks after last administered 4-week dose. Intervention group: Schedule surgery 2 weeks after last administered 4-week dose.
• Abatacept (Biological), also known as Orencia: Control group: Schedule surgery 2 weeks after last administered weekly subcutaneous dose or 5 weeks after last administered monthly intravenous dose. Intervention group: Schedule surgery 1 week after last administered weekly subcutaneous dose or 2 weeks after last administered monthly intravenous dose.
• Secukinumab (Biological), also known as Cosentyx: Control group: Schedule surgery 5 weeks after last administered subcutaneous dose. Intervention group: Schedule surgery 2 weeks after last administered subcutaneous dose.
• Ixekizumab (Biological), also known as Taltz: Control group: Schedule surgery 5 weeks after last administered 4-week dose. Intervention group: Schedule surgery 2 weeks after last administered 4-week dose.
• Bimekizumab (Biological), also known as Bimzelx: Control group: Schedule surgery 9 weeks after last administered 8-week dose. Intervention group: Schedule surgery 4 weeks after last administered 8-week dose
• Ustekinumab (Biological), also known as Stelara: Control group: Schedule surgery 13 weeks after last administered 12-week dose. Intervention group: Schedule surgery 6 weeks after last administered 12-week dose.
• Guselkumab (Biological), also known as Tremfya: Control group: Schedule surgery 9 weeks after last administered 8-week dose. Intervention group: Schedule surgery 4.5 weeks after last administered 8-week dose.
• Risankizumab (Biological), also known as Skyrizi: Control group: Schedule surgery 13 weeks after last administered 12-week dose. Intervention group: Schedule surgery 6-7 weeks after last administered 12-week dose.
• Tofacitinib (Drug), also known as Xeljanz: Control group: Schedule surgery 4 days after last administered daily dose. Intervention group: Schedule surgery 2 days after last administered daily dose.
• Upadacitinib (Drug), also known as Rinvoq: Control group: Withhold 4 days prior to surgery Intervention group: Withhold 2 days prior to surgery

Primary outcomes

• Incidence of wound complications [90-day post operation]
• Incidence of superficial surgical site infections [90-day post operation]
• Incidence of deep surgical site infections [90-day post operation]
• Incidence of return trips to the operating room [90-day post operation]
• Incidence of rheumatologic disease flares [90-day post operation]

Secondary outcomes

• Length of hospital stay [From admission to discharge (on average 2 days)]
• Postoperative pain score as assessed by the VAS for Pain [Week 2]: Visual Analogue Scale (VAS) for Pain is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
• Postoperative pain score as assessed by the VAS for Pain [Week 6]: Visual Analogue Scale (VAS) for Pain is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
• Postoperative pain score as assessed by the VAS for Pain [Month 3]: Visual Analogue Scale (VAS) for Pain is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
• Change in Range of motion (ROM) - active forward elevation (AFE) [Week 2, Month 3]: The normal range for AFE is between 170 and 180 degrees. A decrease suggests reduced range of motion.
• Change in Range of motion (ROM) - external rotation (ER) [Week 2, Month 3]: Normal ER ROM can range from 70 to 90 degrees. A decrease suggests reduced range of motion.
• Change in Range of motion (ROM) - internal rotation (IR) [Week 2, Month 3]: The normal IR ROM is 70 to 90 degrees. A decrease suggests reduced range of motion.
• Change in PROMIS - Physical Function (PF) - Short Form 10a [Week 2, Month 3]: The PROMIS PF-10a asks respondents to rate their ability to perform 10 physical activities. The responses are summed to create a raw score, which ranges from 10 (representing the lowest level of physical function) to 50 (representing the highest level of physical function).
• Change in PROMIS - Pain Interference - Short Form 6a [Week 2, Month 3]: The questionnaire consists of 6 items assessing pain interference. Participants are asked to rate each item from 1 (not at all) to 5 (very much). The PROMIS Pain Interference - Short Form 6a has a possible raw score range of 6 to 30, where higher scores indicate greater pain interference. This raw score is then converted to a T-score, which has a mean of 50 and a standard deviation of 10 in a reference population.
• Change in American Shoulder and Elbow Surgeons (ASES) score [Week 2, Month 3]: The ASES questionnaire is a patient-reported outcome measure used to assess shoulder function and pain. It includes a pain scale (using a visual analog scale) and a functional subscale assessing activities of daily living. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
• Change in Disabilities of the Arm, Shoulder and Hand (DASH) score [Week 2, Month 3]: The DASH is a 30-item, self-report questionnaire designed to measure physical function and symptoms in patients with any or several musculoskeletal disorders of the upper limb. Scores range from 0 to 100, with 0 indicating no disability and 100 indicating the most severe disability. A higher DASH score reflects greater disability and severity of symptoms.
• Proportion of participants who used rescue medications or corticosteroid bursts [Month 3]

Sex: All, ages: 18 Years to any

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.

• Jonathan Samuels, MD, Principal investigator, NYU Langone Health