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. 2018 Oct 30;5(4):216–223. doi: 10.5152/eurjrheum.2018.18162

Supplementary Table 1.

Eligibility criteria (PICOS) for systematic literature review

Criteria Inclusion criteria Exclusion criteria
Population
  • Adult patients (aged ≥18 years) with active or severe active AS

  • Second-line patients who had inadequate response to previous treatments (e.g. conventional treatment with DMARDs, NSAIDs, and/or TNFis)

  • Second-line patients who were intolerant to previous treatments (e.g. conventional treatment with DMARDs, NSAIDs, and/or TNFi)

  • TNFi-naïve patients as long as they had demonstrated previous intolerance or inadequate response to conventional treatments

  • Children

  • Patients with mild or early AS; if the population was mixed (i.e., mild to severe), the studies were excluded if data for active or severe active AS were not reported separately

  • Non-radiographic axial spondyloarthritis

  • Treatment-naïve patients

  • Non-biologic treatments for AS (e.g. DMARDs, NSAIDs)

  • Combinations of the therapies of interest

Intervention
  • Secukinumab

  • Certolizumab pegol

  • Etanercept

  • Adalimumab

  • Infliximab

  • Golimumab

  • Note: The interventions of interest in this review consist of all formulations or routes of administration of the listed treatments at labeled doses

Comparators
  • Interventions listed above

  • Placebo

Outcomes (note that references were only limited by outcomes at full-text review stage)*
Efficacy
  • ASAS score

  • Proportion of patients achieving ASAS 20 response, ASAS 40 response, ASAS 70 response, or ASAS 5/6 response

  • ASAS partial remission

  • Proportion of patients achieving ASAS 20 or ASAS 40 response in the subgroup of patients who are TNFi-naïve, TNFi-IR, or are TNFi-intolerant

  • Patient’s global assessment of disease activity

  • Proportion of patients with inactive disease (ASDAS <1.3)

  • Proportion of patients with clinically important change (defined as ASDAS improvement of ≥1.1)

  • Proportion of patients with major improvement (defined as ASDAS improvement of ≥2.0)

  • BASDAI score

  • Spinal mobility assessed by BASMI [cervical rotation, maximal intermalleolar distance, lateral spinal flexion, lumbar flexion (modified Schober), tragus-to-wall distance], chest expansion, and occiput-to-wall distance

  • BASFI score

  • 44 tender and swollen joint count

  • MASES

  • Serum high-sensitivity C-reactive protein

  • mSASSS score: proportion of patients with a relapse

  • Patient assessment of spinal pain

Health-related quality of life, including:
  • ASQoL

  • EQ-5D

  • SF-36

  • HAQ

  • FACIT-fatigue

Safety
  • Overall AEs

  • Overall serious AEs

  • Mortality

  • Treatment-related mortality

  • Discontinuations due to AEs

  • Individual safety outcomes

  • None

Study design
  • Phase 2, 3, and 4 randomized, controlled, prospective clinical trials

  • Long-term follow-up studies (e.g. open-label follow-up studies with

continuation of treatments in their respective randomized group)
  • Systematic reviews and meta-analyses

  • Non-randomized clinical trials

  • Preclinical studies

  • Phase 1 studies

  • Prognostic studies

  • Retrospective studies

  • Prospective observational studies

  • Case reports

  • Commentaries and letters (publication type)

  • Consensus reports

  • Non-systematic reviews

Language
  • All languages

  • None

Date
  • No limit

  • None

*

In line with the original review, studies were screened for outcomes only during the full-text review; at the title/abstract screening stage, any outcomes will be permitted

In line with the original review, systematic reviews, meta-analyses, and pooled analyses will be included at the title/abstract screening stage and used for identification of any additional primary studies not identified through the database searches, but will be excluded during the full-text review

AE: adverse event; AS: ankylosing spondylitis; ASAS: Assessment of SpondyloArthritis International Society; ASAS 20/40/70: 20%/40%/70% improvement in the ASAS response criteria; ASAS 5/6: 20% improvement in any five of the six domains in the ASAS response criteria; ASDAS: Ankylosing Spondylitis Disease Activity Score; ASQoL: Ankylosing Spondylitis Quality of Life; BASDAI: Bath Ankylosing Spondylitis Disease Activity Index; BASFI: Bath Ankylosing Spondylitis Functional Index; BASMI: Bath Ankylosing Spondylitis Metrology Index; DMARD: disease-modifying anti-rheumatic drug; EQ-5D: 5-dimensions EuroQol Questionnaire; FACIT: Functional Assessment of Chronic Illness Therapy; HAQ: Health Assessment Questionnaire; MASES: Maastricht Ankylosing Spondylitis Enthesitis Score; mSASSS: modified Stoke Ankylosing Spondylitis Spinal Score; NSAID: non-steroidal anti-inflammatory drug; PICOS: population, intervention, comparators, outcomes, and study design; SF-36: 36-item Short-Form Health Survey; TNFi: tumor necrosis factor inhibitor