Significantly higher ACR50 and ACR70 response rates were observed for upadacitinib compared to placebo at week 12, but the effect was seen more slowly. There were more adverse events with both doses of upadacitinib than with placebo and more serious adverse events with the 30 mg dose of upadacitinib, but no new safety signals were identified compared with what has been observed with upadacitinib in rheumatoid arthritis «Cohen SB, van Vollenhoven RF, Winthrop KL ym. Safe...»3. The rates of serious infections, herpes zoster, creatine phosphokinase elevations and neutropaenia were higher for the 30 mg dose than for the 15 mg dose. Rates of deaths and malignancies with upadacitinib appeared consistent with expected rates from the general population «Cohen SB, van Vollenhoven RF, Winthrop KL ym. Safe...»3. The quality and applicability of the evidence are good.
Reference | Study type | Population | Intervention and comparison | Outcomes | Risk of bias |
---|---|---|---|---|---|
RCT=randomized controlled trial, pts=patients, PsA=Psoriatic arthritis, UPA=upadacitinib, PBO= placebo, ADA=adalimumab, DMARD=disease-modifying antirheumatic drug, ACR20/50/70=American College of Rheumatology (ACR) 20 response, HAQ-DI=Health Assessment Questionnaire-Disability Index, sIGA=Static Investigator Global Assessment, PASI75=Psoriasis Area Severity Index, mTSS=modified total Sharp–van der Heijde Score, MDA=minimal disease activity, resolution of enthesitis, noninferiority of UPA vs. ADA, SF-36=Short Form Health Survey questionnaire, PCS= Physical Component Summary, FACIT-F=Functional Assessment of Chronic Illness Therapy-Fatigue score, superiority of UPA vs. ADA, resolution of dactylitis, pain, SAPS=Self-Assessment of Psoriasis Symptoms. | |||||
«McInnes IB, Anderson JK, Magrey M ym. Trial of Upa...»1 | RCT phase III multicenter study. | 1704 pts ≥ 18 years with active PsA and had a historical or current plaque
psoriasis, and an inadequate response or unacceptable side effects with at least one nonbiologic DMARD. (N=1281 patients if ADA is excluded.) |
Oral UPA 15 mg, oral UPA 30 mg, PBO and s.c. ADA. | Primary: ACR20 response at week 12 Secondary: HAQ-DI, sIGA, PASI75, mTSS, MDA, resolution of enthesitis, noninferiority of UPA vs. ADA, SF-36, FACIT-F, superiority of UPA vs. ADA, resolution of dactylitis, pain, SAPS. |
Low |
«Mease PJ, Lertratanakul A, Anderson JK ym. Upadaci...»2 | RCT phase III multicenter study. | 642 pts ≥ 18 yrs with active PsA and prior inadequate response or intolerance to at least one biologic DMARD. | Oral UPA 15 mg, oral UPA 30 mg or PBO at week 12 | Primary: ACR20 response at week 12 Secondary: ACR20 at week 2; ACR50, ACR70, HAQ-DI, FACIT-F, SF-36 and PCS at week 12; sIGA, PASI75 and SAPS at week 16; MDA at week 24. |
Low |
Reference | Comments |
---|---|
«McInnes IB, Anderson JK, Magrey M ym. Trial of Upa...»1 | Study was funded by AbbVie. The extension period is ongoing, with up to 3 years. |
«Mease PJ, Lertratanakul A, Anderson JK ym. Upadaci...»2 | Study was funded by AbbVie. |
Results
Reference | Number of studies and number of patients (I/C) | Follow-up time | Absolute number of events (%) I | Absolute number of events (%) C | Absolute difference (95% CI) |
---|---|---|---|---|---|
I=intervention; C=comparison; CI=confidence interval, UPA=upadacitinib, ADA=adalimumab, PBO= placebo, NA=not applicable | |||||
«McInnes IB, Anderson JK, Magrey M ym. Trial of Upa...»1 | 1704 pts (n=429 UPA 15mg, n=423 UPA 30mg, n=423 PBO, n=429 ADA) | 12 weeks, efficacy and safety up to 24 weeks. | 15 mg UPA 70.6 % 30 mg UPA 78.5% |
36.2 % | 34.5 % (28.2–40.7) 42.3 % (36.3–48.3) |
«Mease PJ, Lertratanakul A, Anderson JK ym. Upadaci...»2 | 642 pts (n= 211 UPA 15 mg, n= 218 UPA 30mg and n= 212 PBO) | 12 weeks, long-term efficacy and safety up to 24 weeks. | 15 mg UPA 56.9 % 30 mg UPA 63.8 % |
24.1 % | 32.8 % (24.0–41.6) 39.7 % (31.1–48.3) |
Level of evidence: high |
Reference | Number of studies and number of patients (I/C) | Follow-up time | Absolute number of events (%) I | Absolute number of events (%) C | Absolute difference (95% CI) |
---|---|---|---|---|---|
I=intervention; C=comparison; CI=confidence interval, UPA=upadacitinib, ADA=adalimumab, PBO= placebo, NA=not applicable | |||||
«McInnes IB, Anderson JK, Magrey M ym. Trial of Upa...»1 | 1704 pts (n=429 UPA 15mg, n=423 UPA 30mg, n=423 PBO, n=429 ADA) | 12 weeks, efficacy | 15 mg UPA 37.5 % 30 mg UPA 51.8 % |
13.2 % | 24.3 % (18.7–29.9) 38.6 % (32.8–44.3) |
«Mease PJ, Lertratanakul A, Anderson JK ym. Upadaci...»2 | 642 pts (n= 211 UPA 15 mg, n= 218 UPA 30mg and n= 212 PBO) | 12 weeks, efficacy | 15 mg UPA 31.8 % 30 mg UPA 37.6 % |
4.7 % |
27.1 % (20.1–33.9) 32.9 % (25.9–39.9) |
Level of evidence: high |
Reference | Number of studies and number of patients (I/C) | Follow-up time | Absolute number of events (%) I | Absolute number of events (%) C | Absolute difference (95% CI) |
---|---|---|---|---|---|
I=intervention; C=comparison; CI=confidence interval, UPA=upadacitinib, ADA=adalimumab, PBO= placebo, NA=not applicable | |||||
«McInnes IB, Anderson JK, Magrey M ym. Trial of Upa...»1 | 1704 pts (n=429 UPA 15mg, n=423 UPA 30mg, n=423 PBO, n=429 ADA) | 12 weeks, efficacy | 15 mg UPA 15.6 % 30 mg UPA 25.3 % |
2.4 % |
13.2 % (9.5–17.0) 22.9 % (18.5–27.3) |
«Mease PJ, Lertratanakul A, Anderson JK ym. Upadaci...»2 | 642 pts (n= 211 UPA 15 mg, n= 218 UPA 30mg and n= 212 PBO) | 12 weeks, efficacy | 15 mg UPA 8.5 % 30 mg UPA 16.5 % |
0.5% | 8.0 % (4.2–11.9) 16.0 % (11.0–21.1) |
Level of evidence: high |
Reference | Number of studies and number of patients (I/C) | Follow-up time | Absolute number of events (%) I | Absolute number of events (%) C | Absolute difference (95% CI) |
---|---|---|---|---|---|
I=intervention; C=comparison; CI=confidence interval, UPA=upadacitinib, ADA=adalimumab, PBO= placebo, NA=not applicable | |||||
«McInnes IB, Anderson JK, Magrey M ym. Trial of Upa...»1 | 1704 pts (n=429 UPA 15mg, n=423 UPA 30mg, n=423 PBO, n=429 ADA) | 24 weeks | 15 mg UPA 66.9 % 30 mg UPA 72.3 % |
59.6 % | |
«Mease PJ, Lertratanakul A, Anderson JK ym. Upadaci...»2 | 642 pts (n= 211 UPA 15 mg, n= 218 UPA 30mg and n= 212 PBO) | 24 weeks | 15 mg UPA 64.0 % 30 mg UPA 78.0 % |
65.6 % | |
Level of evidence: moderate The quality of evidence is downgraded due to short follow-up. |
Reference | Number of studies and number of patients (I/C) | Follow-up time | Absolute number of events (%) I | Absolute number of events (%) C | Absolute difference (95% CI) |
---|---|---|---|---|---|
I=intervention; C=comparison; CI=confidence interval, UPA=upadacitinib, ADA=adalimumab, PBO= placebo, NA=not applicable | |||||
«McInnes IB, Anderson JK, Magrey M ym. Trial of Upa...»1 | 1704 pts (n=429 UPA 15mg, n=423 UPA 30mg, n=423 PBO, n=429 ADA) | 12 weeks, efficacy and safety up to 24 weeks. | 15 mg UPA 70.6 % 30 mg UPA 78.5 % |
36.2 % | 34.5 % (28.2–40.7) 42.3 % (36.3–48.3) |
Level of evidence: moderate |