Why carry out this study? |
Cigarette smoking is associated with greater disease activity in patients with rheumatoid arthritis (RA) and with a reduced response to some RA therapies. |
The impact of smoking on the efficacy of filgotinib, an oral Janus kinase 1 inhibitor, in patients with RA is unknown. |
What was learned from this study? |
Filgotinib provides greater efficacy vs. placebo or methotrexate (MTX) to patients with RA who were MTX-naïve or had an inadequate response to MTX regardless of smoking status, as well as superior disease control vs. adalimumab among current/former smokers with an inadequate MTX response. |
While smokers with RA may expect a reduced effect of MTX or adalimumab vs. non-smokers, patients receiving filgotinib may experience similar efficacy regardless of smoking status. |
Introduction
Methods
Randomized Trial Analysis
Non-smoker (n = 2488) | Former smoker (n = 477) | Current smoker (n = 481) | Total (N = 3446) | p value | |
---|---|---|---|---|---|
Baseline DAS28(CRP) ≤ 5.1 | 603 (24.2) | 144 (30.2) | 121 (25.2) | 868 (25.2) | 0.023 |
Age, years, mean (SD) | 52.1 (13.5) | 57.7 (12.1) | 53.7 (10.4) | 53.1 (13.0) | < 0.001 |
Sex, female | 2145 (86.2) | 308 (64.6) | 298 (62.0) | 2751 (79.8) | < 0.001 |
Geographic region | < 0.001 | ||||
Group Aa | 727 (29.2) | 293 (61.4) | 212 (44.1) | 1232 (35.8) | |
Group Bb | 1180 (47.4) | 99 (20.8) | 164 (34.1) | 1443 (41.9) | |
Group Cc | 329 (13.2) | 24 (5.0) | 41 (8.5) | 394 (11.4) | |
Group Dd | 98 (3.9) | 10 (2.1) | 11 (2.3) | 119 (3.5) | |
Group Ee | 154 (6.2) | 51 (10.7) | 53 (11.0) | 258 (7.5) | |
Number of prior bDMARDs, mean (SD) | 0.2 (0.7) | 0.4 (1.0) | 0.3 (0.9) | 0.3 (0.8) | 0.004 |
Duration of RA, mean (SD) | 6.5 (7.8) | 6.4 (8.5) | 5.7 (7.4) | 6.3 (7.8) | 0.147 |
Baseline HAQ-DI, mean (SD) | 1.6 (0.6) | 1.5 (0.6) | 1.5 (0.6) | 1.6 (0.6) | < 0.001 |
Oral corticosteroid use | 1097 (44.1) | 186 (39.0) | 230 (47.8) | 1513 (43.9) | 0.021 |
Baseline comorbidity | 1189 (47.8) | 316 (66.2) | 271 (56.3) | 1776 (51.5) | < 0.001 |
Baseline NSAID use | 1325 (53.3) | 275 (57.7) | 306 (63.6) | 1906 (55.3) | < 0.001 |
CCP antibody positive | 1826 (73.4) | 352 (73.8) | 382 (79.4) | 2560 (74.3) | 0.021 |
Rheumatoid factor positive | 1738 (69.9) | 349 (73.2) | 382 (79.4) | 2469 (71.6) | < 0.001 |
Insurance Claims-Based Study
Patient and Public Involvement
Results
Randomized Trial Analysis
Smoking status | Adalimumab + MTX (n = 323) | Filgotinib 100 mg + MTX (n = 480) | Filgotinib 200 mg + MTX (n = 475) | |
---|---|---|---|---|
ACR20 | Non-smoker | + 22%a | + 16%a | + 23%a |
Former smoker | + 19% | + 36%a | + 46%a | |
Current smoker | + 17% | + 27%b | + 27%b | |
ACR50 | Non-smoker | + 17%a | + 14%a | + 24%a |
Former smoker | + 13% | + 33%a | + 45%a | |
Current smoker | + 4% | + 17%c | + 27%b | |
ACR70 | Non-smoker | + 9%a | + 9%a | + 18%a |
Former smoker | + 6% | + 30%b | + 29%b | |
Current smoker | − 3% | + 9% | + 15%c | |
CDAI LDA | Non-smoker | + 18%a | + 11%b | + 22%a |
Former smoker | + 14% | + 24%c | + 34%a | |
Current smoker | + 7% | + 17%c | + 25%b | |
DAS28(CRP) ≤ 3.2 | Non-smoker | + 27%a | + 14%a | + 27%a |
Former smoker | + 18% | + 30%b | + 45%a | |
Current smoker | + 1% | + 19%c | + 30%b | |
DAS28(CRP) remission | Non-smoker | + 19%a | + 14%a | + 25%a |
Former smoker | + 9% | + 13% | + 41%a | |
Current smoker | + 6% | + 20%b | + 24%b |
Smoking status | Filgotinib 100 mg + csDMARD (n = 152) | Filgotinib 200 mg + csDMARD (n = 147) | |
---|---|---|---|
ACR20 | Non-smoker | + 26%a | + 34%a |
Former smoker | + 35%b | + 35%c | |
Current smoker | + 21% | + 38%b | |
ACR50 | Non-smoker | + 22%a | + 32%a |
Former smoker | + 4% | + 25% | |
Current smoker | + 9% | + 22% | |
ACR70 | Non-smoker | + 12%b | + 22%a |
Former smoker | − 10% | − 2% | |
Current smoker | + 4% | + 18% | |
CDAI LDA | Non-smoker | + 27%a | + 24%a |
Former smoker | + 17% | + 12% | |
Current smoker | + 23% | + 32%b | |
DAS28(CRP) ≤ 3.2 | Non-smoker | + 26%a | + 30%a |
Former smoker | + 8% | + 25% | |
Current smoker | + 23% | + 27% | |
DAS28(CRP) remission | Non-smoker | + 22%a | + 22%a |
Former smoker | + 4% | − 2% | |
Current smoker | + 17% | + 18% |
Smoking status | Filgotinib 100 mg + MTX (n = 207) | Filgotinib 200 mg + MTX (n = 416) | Filgotinib 200 mg (n = 210) | |
---|---|---|---|---|
ACR20 | Non-smoker | + 11%a | + 19%b | + 15%c |
Former smoker | + 22%a | + 14%a | + 24%a | |
Current smoker | + 16% | + 21%a | + 1% | |
ACR50 | Non-smoker | + 15%c | + 24%b | + 19%b |
Former smoker | + 31%c | + 36%b | + 52%b | |
Current smoker | + 16% | + 28%c | + 6% | |
ACR70 | Non-smoker | + 11%c | + 18%b | + 15%b |
Former smoker | + 23%a | + 27%c | + 46%b | |
Current smoker | + 25%a | + 31%b | + 11% | |
CDAI LDA | Non-smoker | + 19%b | + 23%b | + 17%b |
Former smoker | + 25%a | + 25%c | + 50%b | |
Current smoker | + 14% | + 32%c | + 4% | |
DAS28(CRP) ≤ 3.2 | Non-smoker | + 24%b | + 29%b | + 22%b |
Former smoker | + 17% | + 21%a | + 42%b | |
Current smoker | + 28%a | + 40%b | + 20%a | |
DAS28(CRP) remission | Non-smoker | + 14%c | + 22%b | + 14%c |
Former smoker | + 16% | + 29%c | + 41%b | |
Current smoker | + 24%a | + 27%c | + 5% |