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Journal of Peking University (Health Sciences) ›› 2023, Vol. 55 ›› Issue (6): 1013-1021. doi: 10.19723/j.issn.1671-167X.2023.06.009

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Effectiveness of tofacitinib combined with iguratimod in the treatment of difficult-to-treat moderate-to-severe rheumatoid arthritis

Xue ZOU1,2,Xiao-juan BAI1,Li-qing ZHANG1,*()   

  1. 1. Department of Rheumatology and Immunology, Fenyang Hospital Affiliated to Shanxi Medical University, Shanxi Province Fenyang Hospital, Fenyang 032200, Shanxi, China
    2. Department of Gastroenterology, Suzhou Yongding Hospital, Suzhou 215100, Jiangsu, China
  • Received:2023-08-24 Online:2023-12-18 Published:2023-12-11
  • Contact: Li-qing ZHANG E-mail:zhanglq828@sohu.com
  • Supported by:
    the Key Science and Technology Program of Shanxi Province Fenyang Hospital(2021-2022-03)

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Abstract:

Objective: To investigate the efficacy and safety of iguratimod combined with tofacitinib in patients with difficult-to-treat moderate-to-severe rheumatoid arthritis (RA). Methods: In this prospective clinical study, 30 patients with difficult-to-treat moderate-to-severe RA who attended the Department of Rheumatology and Immunology of Shanxi Province Fenyang Hospital from September 2021 to June 2022 were selected. Twenty-three patients enrollment had been treated with 2 or more conventional synthetic disease modifying anti-rheumatic drugs (DMARDs) for more than 6 months. At least, methotrexate or leflunomide was included. Seven patients were treated with conventional synthetic DMARDs combined with tumor necrosis factor antagonists. Because all the patients had not reached the target of treatment, the combination treatment regimen of DMARDs was changed to iguratimod and tofacitinib. The observation period was 12 weeks. Clinical data were collected before and after treatment. At the end of 4 weeks, 8 weeks and 12 weeks, the clinical data were collected such as swollen joints count (SJC), tender joints count (TJC), time of morning stiffness, clinical disease activity index (CDAI), health status assessment questionnaire (HAQ), and 28-joint disease activity score (DAS28) were included. We collected laboratory indicators, recorded the patient's medication, and observed some changes to see if any adverse drug reactions occurred during the treatment. Results: There were significant differences in erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), rheumatoid factor (RF), platelet (PLT), SJC, TJC, DAS28 based on ESR(DAS28-ESR), time of morning stiffness, HAQ, CDAI, and anti-cyclic citrullinated peptide antibody before and after treatment. The differences had statistical significance (P < 0.05). There was no statistical differences in globulin before and after treatment (P>0.05). During the treatment of iguratimod combined with tofacitinib, there was no serious adverse reactions such as leukopenia, significant elevation of liver enzymes, allergy or thromboemblolic events that occurred in all the patients. Conclusion: Iguratimod combined with tofacitinib in the treatment of difficult-to-treat moderate-to-severe RA may have efficacy. The machanism was improving the patients' recent clinical symptoms by reducing inflammatory indexes. This combination treatment regimen with iguratimod and tofacitinib has a good safety profile.

Key words: Rheumatoid arthritis, Iguratimod, Tofacitinib, Treatment outcome, Safety

CLC Number: 

  • R593.22

Table 1

Pharmacy of patients before enrollment (n=30)"

Usage of drugs n (%)
Two csDMARDs 21 (70.00)
    MTX and HCQ 6 (20.00)
    MTX and SSZ 9 (30.00)
    MTX and IGU 3 (10.00)
    LEF and IGU 2 (6.67)
    LEF and HCQ 1 (3.33)
Three csDMARDs 2 (6.66)
    MTX, HCQ and SSZ 1 (3.33)
    LEF, HCQ and SSZ 1 (3.33)
csDMARDs and bDMARDs 7 (23.34)
    MTX and etanercept 3 (10.00)
    MTX and adalimumab 1 (3.33)
    LEF and etanercept 2 (6.64)
LEF and adalimumab 1 (3.33)
Prednisone (≤10 mg/d) 22 (73.33)
NSAIDs 18 (60.00)

Table 2

Comparison of disease activity indicators before and after treatment (n=30)"

Project Before treatment, M (P25, P75) After treatment, M (P25, P75) Wald χ2 P
4 weeks 8 weeks 12 weeks
ESR/(mm/h) 60.00 (42.75, 82.75) 30.05 (16.5, 53.00) 17.50 (10.05, 30.50) 9.00 (4.25, 13.50) 134.183 <0.001*
CRP/(mg/L) 22.97 (11.81, 43.89) 6.94 (2.20, 15.86) 3.45 (1.03, 6.41) 1.30 (0.33, 3.10) 37.586 <0.001*
RF/(IU/mL) 82.30 (22.43, 308.70) 53.00 (19.38, 202.50) 39.50 (13.40, 111.63) 18.50 (7.23, 59.83) 15.759 0.001*
PLT/(×109/L) 316.50 (234.50, 394.50) 250.50 (210.50, 308.00) 242.50 (213.00, 283.00) 242.00 (213.00, 313.50) 19.278 <0.001*
Globulin/(g/L) 31.60 (25.42, 34.02) 28.05 (24.72, 33.05) 27.30 (23.62, 32.55) 5.648 0.130
DAS28-ESR 4.77 (4.13, 5.60) 3.67 (2.75, 4.10) 1.83 (1.08, 2.94) 1.14 (0.72, 2.62) 393.417 <0.001*
Morning stiffness/min 90.00 (57.50, 120.00) 52.50 (27.50, 120.00) 20.00 (10.00, 41.25) 5.00 (0.00, 16.25) 122.857 <0.001*
SJC 8.50 (5.75, 12.00) 5.00 (2.00, 8.00) 2.50 (1.00, 4.00) 1.00 (0.00, 3.00) 129.482 <0.001*
TJC 9.51 (6.00, 14.25) 7.00 (4.00, 10.00) 3.00 (2.00, 6.00) 2.00 (2.00, 5.50) 153.105 <0.001*
CDAI 32.00 (22.75, 43.00) 24.00 (13.50, 28.00) 9.50 (5.00, 15.00) 5.00 (1.75, 9.75) 211.187 <0.001*
HAQ 10.00 (7.00, 17.00) 6.50 (4.00, 10.00) 5.00 (2.75, 7.25) 2.00 (1.75, 9.75) 141.037 <0.001*
ACPA/(IU/mL) 246.00 (153.75, 294.75) 138.00 (106.50, 232.50) 56.986 <0.001*

Table 3

Comparison of disease activity indicators before and after treatment (generalized estimation equation model analysis and multiple comparisons of time effects based on the before treatment group)"

Project Group β(95%CI) Wald χ2 P
ESR Before treatment
4 weeks -27.867 (-36.365, -19.368) 41.302 <0.001*
8 weeks -40.433 (-49.870, -30.997) 70.524 <0.001*
12 weeks -50.600 (-59.823, -41.377) 115.614 <0.001*
CRP Before treatment
4 weeks -24.367 (-36.299, -12.435) 16.020 <0.001*
8 weeks -30.088 (-42.632, -17.543) 22.100 <0.001*
12 weeks -32.867 (-45.684, -20.049) 25.257 <0.001*
RF Before treatment
4 weeks -42.168 (-69.685, -14.652) 9.022 0.003*
8 weeks -86.759 (-131.934, -41.584) 14.169 <0.001*
12 weeks -139.566 (-222.283, -56.849) 10.936 0.001*
PLT Before treatment
4 weeks -49.900 (-79.813, -19.987) 10.690 <0.001*
8 weeks -56.833 (-83.675, -29.991) 17.221 <0.001*
12 weeks -60.933 (-88.237, -33.630) 19.132 <0.001*
SJC Before treatment
4 weeks -3.733 (-4.595, -2.872) 72.147 <0.001*
8 weeks -6.567 (-7.701, -5.433) 128.777 <0.001*
12 weeks -7.833 (-9.219, -6.447) -15.346 <0.001*
TJC Before treatment
4 weeks -4.000 (-5.205, -2.795) 42.353 <0.001*
8 weeks -6.700 (-8.216, -5.184) 75.053 <0.001*
12 weeks -8.933 (-10.429, -7.438) 137.104 <0.001*
DAS28-ESR Before treatment
4 weeks -1.286 (-1.553, -1.020) 89.469 <0.001*
8 weeks -2.893 (-3.228, -2.557) 285.404 <0.001*
12 weeks -3.459 (-3.801, -3.117) 392.627 <0.001*
Morning stiffness Before treatment
4 weeks -21.000 (-29.333, -12.667) 24.395 <0.001*
8 weeks -57.267 (-68.908, -45.625) 92.962 <0.001*
12 weeks -73.833 (-87.535, -60.132) 111.545 <0.001*
HAQ Before treatment
4 weeks -4.300 (-5.201, -3.399) 87.446 <0.001*
8 weeks -6.700 (-7.877, -5.523) 124.579 <0.001*
12 weeks -8.900 (-10.394, -7.406) 136.386 <0.001*
CDAI Before treatment
4 weeks -11.217 (-13.516, -8.917) 91.402 <0.001*
8 weeks -21.650 (-25.044, -18.256) 156.323 <0.001*
12 weeks -26.350 (-30.079, -22.621) 191.827 <0.001*
ACPA Before treatment
After treatment -68.267 (-85.991, -50.542) 56.986 <0.001*

Table 4

Comparison of disease activity composition ratio before and after treatment (n=30)"

Items Remission, n (%) Low disease activity, n (%) Moderate disease activity, n (%) High disease activity, n (%) Z P
Before treatment 0 (0) 0 (0) 16 (53.33) 14 (46.67)
4 weeks 7 (23.33) 3 (10.00) 15 (50.00) 5 (16.67) -3.491 <0.05*
8 weeks 15 (50.00) 10 (33.33) 3 (10.00) 2 (6.67) -5.828 <0.05*
12 weeks 21 (70.00) 7 (23.33) 2 (6.67) 0 (0) -6.704 <0.05*

Table 5

Comparison of disease activity indicators at 4, 8 and 12 weeks after treatment and before treatment (t test)"

Items ESR CRP RF PLT DAS28-ESR Morning stiffness SJC TJC CDAI HAQ ACPA
4 weeks t -7.51 -5.23 -1.54 -4.18 -8.16 -3.81 -7.31 -6.61 -8.10 -8.58
P <0.05* <0.05* 0.12 <0.05* <0.05* <0.05* <0.05* <0.05* <0.05* <0.05*
8 weeks t -10.91 -6.46 0.002 -4.77 -18.35 -10.40 -12.86 -11.08 -15.64 -15.64
P <0.05* <0.05* <0.05* <0.05* <0.05* <0.05* <0.05* <0.05* <0.05* <0.05*
12 weeks t -13.65 -7.06 -5.12 -5.11 -21.95 -12.86 -15.34 -14.77 -19.04 -19.04 -7.42
P <0.05* <0.05* <0.05* <0.05* <0.05* <0.05* <0.05* <0.05* <0.05* <0.05* <0.05*

Figure 1

Comparison of DAS28-ESR composition ratio before and after treatment (n=30) DAS28, 28-joint disease activity score; ESR, erythrocyte sedimentation rate."

Table 6

Comparison of routine laboratory indicators before and after treatment (n=30)"

Project Before treatment, M (P25, P75) After treatment, M (P25, P75) Wald χ2 P
4 weeks 8 weeks 12 weeks
WBC/(×109/L) 7.35 (6.48, 8.84) 6.74 (5.57, 7.90) 6.39 (5.08, 7.73) 6.07 (5.43, 7.56) 5.090 0.165
RBC/(×1012/L) 4.27 (4.09, 4.67) 4.40 (4.17, 4.65) 4.51 (4.25, 4.90) 4.49 (4.26, 4.83) 15.936 0.001*
HGB/(g/L) 125.50 (111.75, 137.25) 122.00 (114.75, 129.25) 126.50 (114.75, 142.50) 132.00 (121.00, 141.75) 10.300 0.016*
ALT/(U/L) 17.00 (15.00, 27.00) 18.50 (14.00, 23.25) 17.00 (15.00, 24.00) 18.50 (15.75, 25.75) 9.138 0.028*
AST/(U/L) 18.50 (15.00, 25.25) 18.50 (14.00, 23.00) 19.50 (15.00, 24.00) 18.50 (15.00, 28.00) 1.905 0.592
GGT/(U/L) 19.00 (14.00, 31.50) 18.00 (14.75, 22.50) 15.50 (12.75, 23.50) 15.00 (12.00, 22.50) 2.727 0.436
Total protein/(g/L) 74.00 (71.87, 76.62) 76.00 (69.20, 77.85) 73.25 (70.75, 77.47) 73.30 (70.00, 82.22) 2.417 0.490
Albumin/(g/L) 43.95 (41.60, 46.15) 44.70 (42.92, 47.35) 45.55 (42.77, 47.52) 45.65 (43.30, 47.45) 5.845 0.119
Cr/(μmol/L) 62.50 (56.75, 72.50) 65.00 (59.00, 76.30) 67.00 (56.75, 73.50) 66.00 (58.75, 77.00) 5.149 0.161
BUN/(mmol/L) 4.40 (3.70, 5.02) 4.60 (4.20, 5.45) 4.70 (4.40, 6.10) 4.65 (4.37, 5.32) 8.214 0.042*

Table 7

Comparison of routine testing indicators before and after treatment (n=30)"

Project Group β(95%CI) Wald χ2 P
RBC Before treatment
4 weeks 0.369 (0.022, 0.717) 4.334 0.037*
8 weeks 0.261 (0.063, 0.460) 6.674 0.010*
12 weeks 0.532 (0.234, 0.831) 12.227 <0.001*
HGB Before treatment
4 weeks -2.433 (-9.203, 4.336) 0.496 0.481
8 weeks 2.300 (-3.816, 8.416) 0.543 0.461
12 weeks 6.500 (-1.942, 14.942) 2.277 0.131
ALT Before treatment
4 weeks -4.933 (-8.176, -1.690) 8.890 0.003*
8 weeks -3.633 (-7.479, 0.212) 3.429 0.064*
12 weeks -2.333 (-6.553, 1.886) 1.175 0.278
BUN Before treatment
4 weeks 0.297 (-0.124, 0.717) 1.911 0.167
8 weeks 4.237 (-0.886, 9.359) 2.628 0.105
12 weeks 0.360 (0.037, 0.683) 4.766 0.029*
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