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. 2020 Dec 29;57(1):23. doi: 10.3390/medicina57010023

Table 1.

Study characteristics.

Author and Year Country/Study Type Sample Size Blinding Follow-Up Intervention Foot Outcome Results
Tada et al., 2016 [30] Japan
Retrospective study		 227 patients with RA

  • Mean of age 65.0

  • n female = 197 (86.7%)

Rates of biologics and conventional synthetic DMARD (csDMARD) administration were 30.4 and 91.0%, respectively.		 No Between 2006 and 2013 Orthopedic surgeries.

  • Disease Activity Score (DAS28)

  • Surgical site infection (SSI). (odds ratio (OR), 1.11; p = 0.045),

  • Wound healing (OR, 3.66; p = 0.003).

 Biologics were not risk factors for post-operative SSI.
Foot surgery was a risk factor for delayed wound healing, due to the severe foot deformities, which causes swelling and increased skin turgor
Kadota et al., 2016 [31] Japan
Retrospective study		 204 foot and ankle surgeries in RA patients.
157 with biologics treatment and 47 with csDMARD treatment.		 No Between
January 2004 and December 2012		 Orthopedic procedures.

  • SSI (OR), 3.167; Confidential Interval (CI), 1.256–7.986; p = 0.015).

  • Delayed wound healing (DWH) (OR 1.004; CI, 1.000–1.007; p = 0.029)

 SSI and DWH were identified in 8 cases (7 with csDMARD treatment) and 3 cases (2 with csDMARD treatment), respectively.
Foot and ankle surgery were associated with an increased risk of SSI.
Van Herwaarden et al., 2015 [32] Netherlands
Randomize Control Trial (RCT)		 180 patients with RA:
n = 121 with biologics and dose reduction

  • Mean of age 59

  • n female = 75 (61%)

n = 59 without dose reduction (usual care).

  • Mean of age 58

  • n female = 41 (69%)

 No 18 months Biologics vs. usual care in RA

  • DAS28

  • Health assessment questionnaire–disability index (HAQ–DI).

  • EuroQol-5D

  • Cumulative incidence of flares

  • Radiological outcomes

short lived flares (73% v 27%) and minimal
radiographic progression (32% v 15%)		 Biologics are non-inferior to usual care regarding outcomes
Huizinga et al., 2015 [33] Multicentre: Netherlands, UK, Spain, Germany, Israel, Brazil USA, Switzerland and France.RCT From 556 randomized patients,
N = 279 biologics tocilizumab (TCZ) + methotrexate (MTX) (add-on) and

  • n females = 227 (81.9%)

  • Mean of age 53

  • n = 277 TCZ + (Placebo)PBO (switch).

  • n females = 217 (78.6%)

  • Mean of age 53.6

Completed week 104:
n = 222 TCZ + MTX (add-on)
n = 201 TCZ + PBO (switch).		 Yes Over 24 months Patients with active RA despite MTX were randomized to add TCZ to ongoing MTX (add-on) or switch to TCZ plus placebo (PBO) (switch).

  • Disease Activity Score (DAS28)

  • RA quality of life questionnaire

  • Tender joint count.

  • Swollen joint count.

  • HAQ–DI.

  • Patient’s global assessment.

  • Physician’s global assessment.

  • C-reactive protein

  • Radiographs of hands/wrists and feet. 50.4% discontinued TCZ after achieving sustained remission, and 5.9% achieved drug-free remission

 Most patients demonstrated minimal
progression of radiographic structural damage, with differences
favoring the add-on group (p = 0.034).
Serious adverse events and serious infections per 100 patient-years were 12.2 and 4.4 in add-on and 15.0 and 3.7 in switch patients.
Kubota et al., 2014 [34] Japan
Retrospective study		 87 foot and ankle surgeries in RA patients.
50 with biologics and 37 with non-biologics.		 No Between January 2006 and December 2011. Orthopedic surgery.

  • SSI (p = 0.001), (OR)19.27; (CI) 4.67–79.45].

  • Late infection

 The use of biologics does not significantly increase the incidences of SSI and late infection after orthopedic surgery
Van Vollenhoven et al., 2012 [35] Sweden
RCT		 487 patients with RA and previous treatment with MTX. After 3–4 months, those who their treatment failed:n = 130 (group A) with conventional treatment

  • Mean of age 52.9

  • n female = 101 (78%)

n = 128 (group B) with biologics.

  • Mean of age 51.1

  • n female= 79 (76%)

 No 24 months Addition of conventional disease modifying antirheumatic drugs (group A) vs. addition of biologics (group B) vs.

  • DAS28

  • HAQ-DI

  • Health-economic outcomes

 Radiological outcomes (mean 7·23 Standard deviation (SD) 12·72) vs. 4·00 (10·0); p = 0·009). In group B, good response was non-significantly greater than it was in group A. After 24 months, radiological disease progression was greater in patients in group A than it was in those in group B (p = 0·009).
Kubota et al., 2012 [36] Japan
Retrospective study		 84 foot and ankle surgeries in RA patients.
47 with biologics and 37 with non-biologics		 No Between January 2006 and December 2010 Orthopedic surgery.

  • SSI (p = 0.956)

  • Late infection (p = 0.55)

 No statistically significant difference between groups. The use of biologics may not affect the incidence of post-operative wound healing and SSI.
Bibbo et al., 2004 [37] USA
Prospective study		 n = 28 females (90%) overall
n = 16 biologics (group 1)
n = 15 not receive biologics (group 2)		 No 12 months Risk for healing and infectious complications

  • smoking history

  • Development of infectious/healing complication (p = 0.033).

 Group 1 demonstrated a lower complication rate
(p = 0.033) in healing and infection.