The Evaluation of Injection Site Pain and Adherence in Patients Switching From a Low To High Concentration Adalimumab (AVT-02) Across Multiple Indications.

The current phase 4 study seeks to assess the real-world injection experience, utilization, satisfaction, effectiveness, safety, and tolerability of treatment with AVT-02 (SIMLANDI™) in patients when switching from low-concentration adalimumab Humira® or another adalimumab biosimilar to high-concentration adalimumab SIMLANDI™ for the management of certain gastroenterological (IBD, including CD or UC); rheumatological (including RA, AS, or PsA); or dermatological conditions (including HS or PsO).

Inclusion criteria

• Patient aged 18 years or older at the time of consent.
• Patient has been diagnosed with CD, UC, RA, AS, PsA, HS, or PsO for at least 6 months.
• Patient must be a current user of Humira® or another low-concentration adalimumab biosimilar, with treatment initiated at least 6 months prior to screening.
• One of the following:

• Treating physician is considering switching from Humira® to SIMLANDI™,
• Treating physician is considering switching from an adalimumab biosimilar (not Humira®) to SIMLANDI™.
• Treating physician has switched from Humira® or Humira® biosimilar to SIMLANDI™ within the past 3 months.
• Patient must be willing to keep using the same type of injector when switching from their previous adalimumab treatment to SIMLANDI™:

• Pre-filled to pre-filled switch,
• Autoinjector to autoinjector switch.
• Access to commercial SIMLANDI™.
• Patient or patient's legal/authorized representative agrees to sign informed consent and participate in the study.

Exclusion criteria

• Patients previously treated with SIMLANDI™ or another high-concentration adalimumab biosimilar.
• Patients that, in the opinion of the investigator, have any condition that may impair their ability to participate in the study.
• Any current or history of any condition that, in the opinion of the investigator, participation in the study may increase the risk to the patient.
• Patients for whom treatment with adalimumab may be contraindicated (e.g., patients with demyelinating disorders).
• Patients with moderate to severe heart failure, as indicated by New York Heart Association (NYHA) class >= 3.
• Patients with severe infections such as sepsis, tuberculosis, or opportunistic infections.
• Patients with history of recurrent infection or with underlying conditions which may predispose them to infections.
• Patients with known hypersensitivity to SIMLANDI™ or its excipients.
• Patients who are unable to secure reimbursement for SIMLANDI™.
• Patient anticipates not being available for follow-up assessments as required for adequate management.
• Active participation in or enrollment in an interventional trial.
• Patient or patient's legal/authorized representative cannot or will not sign informed consent.