Session Information
Date: Sunday, November 13, 2016
Session Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy - Poster I
Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose: Obese rheumatoid arthritis (RA) patients (pts) may have higher levels of inflammatory mediators, greater joint swelling and tenderness, and suboptimal response to therapy. We assessed disease activity and treatment response in obese RA pts, using ultrasonography (US) and clinical measures.
Methods: This post hoc analysis used observed data from the MUSICA trial which evaluated the efficacy of high [20 mg/week (wk)] or low (7.5 mg/wk) doses of methotrexate (MTX) in combination with adalimumab (ADA) for 24 weeks (wks) in RA pts with previous inadequate response to MTX who initiated ADA. Pts were grouped according to body mass index (BMI) at baseline (BL): normal BMI<25; overweight BMI ≥25-<30; obese BMI ≥30. Synovial vascularity and hypertrophy were measured by Power Doppler US and Greyscale respectively, bilaterally, at metacarpophalangeal (MCP) joints 2, 3, 5, metatarsophalangeal joint 5 (MTP5) and wrists. Swollen joint count (SJC) of 66 joints, tender joint count (TJC) of 68 joints, 28-joint count Disease Activity Score using C-reactive protein (DAS28-CRP), and numbers of pts reaching American College of Rheumatology (ACR) criteria, Clinical Disease Activity Index [CDAI] low disease activity (LDA,<10), DAS28-CRP low disease activity (LDA; DAS<3.2), were assessed at wks 12 and 24.
Results: Out of 308 pts at BL, 69 pts (22.4%) had BMI <25,102 pts (33.1%) had BMI ≥25-<30 and 137 pts (44.5%) had BMI ≥30. Disease characteristics and ultrasound disease assessments were similar for the 3 BMI subgroups at BL. At wks 12 and 24, compared with pts in the normal and overweight categories, obese pts tended to have numerically smaller mean changes from BL in SJC66, TJC68, DAS28-CRP, synovial hypertrophy and synovial vascularity (table). Compared to pts in the normal and overweight categories, significantly fewer obese pts reached ACR20/50 at wks 12 and 24. Significantly fewer obese pts reached CDAI LDA and DAS28-CRP LDA at wk 12; this difference was driven by those obese pts receiving low dosage of concomitant MTX (7.5 mg/wk), although by wk 24, the differences were no longer significant. There was low to no correlation between synovial vascularity/hypertrophy and clinical findings of swelling and tenderness. The proportion of pts with synovial vascularity=0 in the 3 BMI subgroups at wks 12 and 24 was not statistically different.
Conclusion: Among obese RA pts initiating ADA, those on low dosage of concomitant MTX had poorer responses than pts in the normal and overweight categories, as measured clinically and by ultrasound imaging, although this effect was partly overcome by wk 24. Obese RA pts may have an improved clinical benefit if ADA is initiated with high (20 mg/week), rather than low dosage of concomitant MTX.
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week 12 |
week 24 |
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| MTX mg/wk | Normal (BMI <25) | Overweight (BMI ≥25-<30) | Obese (BMI ≥30) | Normal (BMI <25) | Overweight (BMI ≥25-<30) | Obese (BMI ≥30) |
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Mean change from baseline in SJC66 |
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| 7.5 | -8.7 (1.45) | -10.2 (1.24) | -7.3 (1.11) | -8.3 (1.70) | -11.2 (1.37) | -7.2 (1.23) |
| 20 | -12.1 (1.58) | -8.3 (1.26) | -9.3 (1.04) | -13.9(1.76) | -11.6(1.37) | -10.3 (1.16) |
| Overall | -10.4 (1.08) | -9.2 (0.88) | -8.3 (0.76) | -11.1 (1.22) | -11.4 (1.0) | -8.7 (0.85) |
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Mean change from baseline in TJC68 |
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| 7.5 | -16.0 (2.24) | -14.5 (1.87) | -14.2 (1.67) | -16.7 (2.36) | -19.6 (1.90) | -15.8 (1.71) |
| 20 | -16.5 (2.38) | -15.44 (1.91) | -13.6 (1.58) | -18.1 (2.44) | -19.4 (1.91) | -17.3 (1.62) |
| Overall | -16.2 (1.64) | -15.0 (1.33) | -13.9 (1.15) | -17.4 (1.70) | -19.5 (1.35) | -16.6 (1.18) |
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Mean change from baseline in synovial hypertrophy |
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| 7.5 | -1.1 (0.91)** | -2.9 (0.73)** | 0.7 (0.67)** | -1.8 (0.88) | -2.1 (0.71) | 0.3 (0.66) |
| 20 | -2.0 (0.94) | -1.0 (0.75) | -0.8 (0.61) | -0.8 (0.95)* | -1.3 (0.71)* | 1.0 (0.60)* |
| Overall | -1.55 (0.65)* | -2.0 (0.52)* | -0.1 (0.45)* | -1.3 (0.65) | -1.7 (0.50) | -0.34 (0.44) |
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Mean change from baseline in synovial vascularity |
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| 7.5 | -1.7 (0.64) | -1.3 (0.52) | -0.7 (0.47) | -2.0 (0.59) | -1.2 (0.47) | -1.6 (0.44) |
| 20 | -2.3 (0.66) | -1.6 (0.53) | -1.5 (0.43) | -2.1 (0.64) | -1.3 (0.48) | -1.7 (0.40) |
| Overall | -2.0 (0.46) | -1.4 (0.37) | -1.1 (0.32) | -2.0 (0.43) | -1.3 (0.34) | -1.7 (0.30) |
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Patients reaching ACR 20, n/N (%) |
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| 7.5 | 20/34 (58.8)* | 29/48 (60.4)* | 23/60 (38.3)* | 21/30 (70.0)** | 32/46 (69.6)** | 25/57 (43.9)** |
| 20 | 18/30 (60.0) | 24/47 (51.1) | 33/69 (47.8) | 18/28 (64.3) | 30/46 (65.2) | 36/63 (57.1) |
| Overall | 38/64 (59.4)* |
53/95 (55.8)* |
56/129 (43.4)* | 39/58 (67.2) | 62/92 (67.4) | 61/120 (50.8) |
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Patients reaching ACR 50, n/N (%) |
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| 7.5 | 10/34 (29.4)* | 13/48 (27.1)* | 5/60 (8.3)* | 14/30 (46.7) | 17/46 (37.0) | 12/57 (21.1) |
| 20 | 13/30 (43.3) | 14/47 (29.8) | 15/69 (21.7) | 11/28(39.3) | 20/46 (43.5) | 20/63 (31.7) |
| Overall | 23/64 (35.9)** | 27/95 (28.4)** | 20/129 (15.5)** | 25/58 (43.1) | 37.9 (40.2) | 32/120 (26.7) |
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Patients reaching DAS28-CRP LDA, n/N (%) |
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| 7.5 | 10/31 (32.3) | 10/46 (21.7) | 7/57 (12.3) | 12/29 (41.4) | 16/46 (34.8) | 13/55 (23.6) |
| 20 | 8/25 (32.0) | 14/42 (33.3) | 10/67 (14.9) | 7/24 (29.2) | 19/44 (43.2) | 22/58 (37.9) |
| Overall | 18/56 (32.1)** | 24/88 (27/3)** | 17/124 (13.7)** | 19/53 (35.8) | 35/90 (38.9) | 35/113 (31.0) |
| P values for comparison between BMI subgroups. *p <.05, ** <.001. Chi-squared test was used for categorical variables, ANCOVA adjusting for baseline, treatment and BMI group was used for continuous variables. | ||||||
To cite this abstract in AMA style:
Kaeley GS, Ranganath VK, MacCarter DK, Pangan AL, Wang X, Kalabic J. Clinical Responses and Synovial Vascularity in Obese Rheumatoid Arthritis Patients Treated with Adalimumab and Methotrexate [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/clinical-responses-and-synovial-vascularity-in-obese-rheumatoid-arthritis-patients-treated-with-adalimumab-and-methotrexate/. Accessed December 3, 2021.« Back to 2016 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/clinical-responses-and-synovial-vascularity-in-obese-rheumatoid-arthritis-patients-treated-with-adalimumab-and-methotrexate/