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. 2024 Jan 18;12(1):e008266. doi: 10.1136/jitc-2023-008266

Table 1.

Eligibility criteria for inclusion in the systematic review

Criteria Include
Population Subjects receiving treatment for cancer with no restriction on patient characteristics, indication (including tumor type, ie, solid vs liquid tumors), or line of therapy
(Papers reporting relevant ADA-related data in other indications, eg, rheumatoid arthritis, multiple sclerosis, lupus were tagged but were not eligible for inclusion)
Intervention and comparator(s)
  • PD-1 inhibitors

  • PD-L1 inhibitors

  • CTLA-4 inhibitors

No restriction on treatment regimen and may be administered as monotherapy or in combination
Outcomes
  • Impact of immunogenicity on:

    • Pharmacokinetics

      • Safety/tolerability, including hypersensitivity reactions

      • Anaphylaxis

      • Infusion reactions

      • Immune-complex mediated diseases

    • Efficacy

    • Target binding

    • Drug clearance

  • Incidence and prevalence of ADAs/nAbs (no restriction on assay employed) and link to patient outcome

  • Type of antibody, that is, IgM vs IgG

  • Predictors of ADA production

  • Mechanisms underlying ADA formation

  • Impact of assay used to detect ADAs on outcomes of interest

Study design
  • Randomized controlled trials (all phases)

  • Long-term extensions to randomized controlled trials

  • Non-randomized clinical studies

  • Observational studies (prospective and retrospective)

  • Post hoc analysis of clinical studies

  • SR and meta-analysis publications

(Single patient case studies were tagged but not extracted)
Geography No restriction
Date of publication No restriction
Language of publication No restriction. The primary focus was English language publications or non-English language publications with an English abstract

ADA, antidrug antibody; CTLA-4, cytotoxic T-lymphocyte-associated protein 4; Ig, immunoglobulin; nAb, neutralizing antibody; PD-1, programmed cell death protein 1; PD-L1, programmed cell death-ligand 1; SR, systematic review.