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. 2020 Jul 11;4(2):rkaa032. doi: 10.1093/rap/rkaa032

Table 1.

List of references fulfilling the eligibility criteria set by the search protocol

Reference (in order of publication, where applicable) Condition mentioned in inclusion criteria Condition targeted and primary outcome measure Intervention Effect of the intervention Comments

  • Scarpa et al. (2008) [22]

  • Randomized, open label clinical trial

  • PsA: Moll/Wright

  • Sample size: 35

  • • MSK

  • • Unclear (TJC, SJC, VAS, ESR, CRP, PGA, PhGA); variables collected at baseline, 3 and 6 months

  • No cutaneous secondary outcome

  • Arm 1: NSAIDs + MTX

  • Arm 2: NSAIDs step-up (followed by MTX)

  • No placebo arm

 No difference (TJC, SJC, VAS, ESR, CRP, PGA, PhGA) between arms at 6 months

  • Participants in arm 1 experienced earlier reduction of SJC and TJC at 3 months

  • Information available from report does not suggest participants might have been exposed to systemic CS before enrolment

  • No information available about previous exposure to systemic therapy for cutaneous disease

  • Sticherling et al. (2017) [23]

  • Acronym: PRIME

  • Randomized, open label clinical trial

  • Plaque psoriasis

  • Sample size: 202

  • • Cutaneous

  • • PASI75 at week 24

  • No MSK secondary outcome

  • Arm 1: SEC

  • Arm 2: FAE

  • No placebo arm

 85.9% of arm 1 participants achieved PASI75 vs 33.7% of arm 2 (P < 0.001)

  • Information available from report does not suggest that participants might have been exposed to systemic therapies (including CS) before enrolment

  • No information available about previous use of anti-rheumatic drugs for MSK disease, but exclusion criteria wording and low PsA prevalence (6%) do not suggest previous exposure

  • Strober et al. (2017) [24]

  • Acronym: UNVEIL

  • Randomized, double blinded trial

  • Plaque psoriasis

  • Sample size: 221

  • • Cutaneous

  • • sPGA×BSA at week 16

  • No MSK secondary outcome

  • Arm 1: APM

  • Arm 2: placebo

 Mean percentage change in sPGA×BSA greater in arm 1 than in arm 2 (−48.1 vs −10.2%; P <0.0001) Information available from report suggests that no participant was exposed to systemic/immune-suppressant therapy, for the purpose of treating any condition, before enrolment

  • Loginova et al. (2018) [25]

  • Cohort study

  • PsA: CASPAR

  • No declared target sample size

  • • MSK

  • • Unclear (DAPSA-remission or MDA); observation over 24 months, data collection every 3 months

  • No cutaneous secondary outcome

 MTX, step up to MTX + bDMARDs if DAPSA remission or MDA not achieved (T2T approach) 41 participants (53.2%) achieved DAPSA remission or MDA within 7 ± 5 months, using MTX monotherapy (≤25 mg/week)

  • Enrolment in this cohort is ongoing (data about 77 participants in this report)

  • No information available about previous exposure to systemic therapy for cutaneous disease

  • Reich et al. (2020) [21]

  • Randomized, single blinded clinical trial

  • Plaque psoriasis

  • Sample size: 162

  • • Cutaneous

  • • PASI75 at week 24

  • No MSK secondary outcome

  • Arm 1: IXK

  • Arm 2: FAE

  • Arm 3: MTX

  • No placebo arm

 90.7% of arm 1 participants achieved PASI75 vs 22.2% of arm 2 (P < 0.0001) vs 70.4% of arm 3 (P = 0.0137)

  • Information available from report suggests that no participant was exposed to systemic/immune-suppressant therapy for the purpose of treating a cutaneous condition before enrolment

  • MSK disease prevalence not described. No information available about previous exposure to anti-rheumatic drugs for MSK disease

  • Iversen et al. (2018) [29]

  • Acronym: STEPIn

  • Randomized, open label clinical trial

  • Unpublished (last checked 3 April 2020)

  • Plaque psoriasis

  • Target sample size: 196 (updated May 2017)

  • • Cutaneous

  • • PASI90 at week 52

  • No MSK secondary outcome

  • Arm 1: SEC

  • Arm 2: NB-UVB

  • No placebo arm

 Not available

  • Information available from published protocol does not exclude that participants might have been exposed to systemic CS or immunosuppressants before enrolment

  • Information available from published protocol does not exclude that participants naïve to treatment (main study) would be described separately

  • CTRI/2017/06/008888 [27]

  • Randomized, open label clinical trial

  • Unpublished (last checked 3 April 2020)

  • PsA: CASPAR

  • Target sample size: 242

  • • MSK

  • • PsARC at week 24

  • (peripheral arthritis)

  • Cutaneous secondary outcome: PASI

  • Arm 1: MTX

  • Arm 2: MTX + LEF

  • No placebo arm

 Not available

  • Information available from trial register does not suggest that participants might have been exposed to systemic CS before enrolment

  • No information available about previous exposure to systemic therapy for cutaneous disease

  • EUCTR2017-004542-24-GB [28]

  • Acronym: SPEED

  • Randomized, single blinded clinical trial

  • Unpublished (last checked 3 April 2020)

  • PsA: CASPAR

  • Target sample size: 315

  • • MSK

  • • PASDAS at week 24

  • No cutaneous secondary outcome

  • Arm 1: MTX step-up (followed by SSZ or LEF)

  • Arm 2: MTX + SSZ/LEF

  • Arm 3: MTX + ADA

  • No placebo arm

 Not available Information available from trial register does not exclude that participants might have been exposed to systemic CS or systemic therapy for cutaneous disease before enrolment

  • NCT02951533 [26]

  • Acronym: POLARIS

  • Randomized, open label, single blinded clinical trial

  • Unpublished (last checked 3 April 2020)

  • Plaque psoriasis

  • Target sample size: 114

  • • Cutaneous

  • • PASI90 at week 24

  • No MSK secondary outcome

  • Arm 1: GUK

  • Arm 2: FAE

  • No placebo arm

  • Results available from clinical trial register

  • 81.7% of arm 1 participants achieved PASI90 vs 13.6% of arm 2 (P < 0.0001)

  • Data about disease duration not yet available

  • The trial protocol, available from trial register, clearly states that participants could be enrolled only if never exposed to systemic therapies for psoriasis

  • In the eligibility criteria, the protocol does not mention previous exposure to CS or anti-rheumatic drugs for MSK disease

Materials appraised were publicly available documents, such as reports from indexed medical journals (full-text articles), supplementary files and attachments from paper publications or web sites (i.e. clinical trials registers).

ADA: adalimumab; APM: apremilast; bDMARDs: biologic DMARDs; CASPAR: classification criteria [357]; DAPSA: disease activity index for PsA; FAE: fumaric acid esters; GUK: guselkumab; IXK: ixekizumab; MDA: minimal disease activity; MOLL/WRIGHT: classification criteria [356]; MSK: musculoskeletal; NB-UVB: narrow-band ultraviolet B; PASDAS: PsA DAS; PASI75: improvement of the psoriasis area and severity index by 75%; PASI90: improvement of the psoriasis area and severity index (PASI) by 90%; PGA: patient global assessment; PhGA: physician global assessment; PsARC: PsA response criteria; SEC: secukinumab; sPGA: static physician’s global assessment; T2T: treat-to-target; TJC/SJC: tender/swollen joints count; VAS: visual analog scale.