Rheumatology 2021;60:ii17–ii23

Rheumatology doi:10.1093/rheumatology/keaa823

Phase III trials of JAK1 selective inhibitors in

rheumatoid arthritis
Eduardo Mysler1 and Ana Lizarraga1

Abstract
Upadacitinib and filgotinib, two JAK1 selective drugs have undergone extensive phase III clinical trials in RA and
have demonstrated rapid improvements in disease activity, function and patient reported outcomes. Six global
phase III randomized controlled clinical trials (SELECT phase III program) evaluated the efficacy and safety of upa-
dacitinib and four clinical phase III trials (the FINCH program) evaluated the efficacy and safety of filgotinib. This
article is a critical review of all these studies with focus on the therapeutic efficacy in RA. The aim is to display the
data that could allow the approval of these new drugs for the treatment of RA (upadacitinib has been already
approved in most of the markets around the world).
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Key words: rheumatoid arthritis, JAK1 inhibitors, upadacitinb, filgotinib, efficacy

SUPPLEMENT
Rheumatology key messages

. Upadacitinib and filgotinib have shown superiority in two different head-to-head clinical trials when compared to
the standard of care.
. JAK1 selective inhibitors favourable efficacy data will allow, if safety is proven, to be included in the rheumatoid
arthritis treatment arsenal.

Introduction drugs have undergone extensive phase III clinical trials

in RA and demonstrated rapid improvements in disease
Since the approval of the first-generation of Janus kin- activity, function and patient-reported outcomes.
ase (JAK) inhibitors, tofacitinib and baricitinib, the search Upadacitinib (UPA) is a JAK inhibitor selective for JAK1
for new innovative JAK inhibitors with more specific se- 74-fold over JAK2 [2]. Six global phase III randomized con-
lectivity has started. It has been hypothesized that the trolled clinical trials (SELECT phase III program) evaluated
inhibition of JAK1 will allow the same clinical efficacy as the efficacy and safety of upadacitinib covering different RA
a non-selective pan-JAK inhibitor (or event better as the subpopulations. There is also information available about
dose could be increased), but with a better safety profile radiographic outcomes and extension trials are ongoing.
potentially guaranteed by the non-inhibition of JAK3 [1]. Filgotinib is a selective JAK inhibitor with a selectivity
Therefore, upadacitinib and filgotinib, two JAK1 selective for JAK1 vs JAK2 of near 30-fold [2]. The FINCH program
includes four clinical phase III trials conducted also in dif-
1 ferent RA patient types that is now under evaluation.
Department of Rheumatology, OMI (Medical Research
Organization), Uruguay, Buenos Aires, Argentina The aim of this article is to review the phase III clinical
Submitted 9 August 2020; accepted 3 November 2020 data for upadacitinib and filgotinib, with focus on the
therapeutic efficacy in RA. Critical evaluation of these
Correspondence to: Eduardo Mysler, OMI (Medical Research
Organization), 725 PB, Uruguay, Buenos Aires, 1015, Argentina. new drugs is crucial, in order to help clinicians chose
E-mail:[email protected] the best treatment for their patients.

C The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Rheumatology.
V
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use,
distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact [email protected]
Eduardo Mysler and Ana Lizarraga

TABLE 1 SELECT phase III studies

Study Early Monotherapy Compare Next Beyond Choice

Population MTX naive MTX IR MTX IR csDMARD IR bDMARD IR bDMARD IR

Type of Mono Mono Combo Combo Combo Combo
therapy
Background MTX csDMARDs csDMARDs csDMARDs
Active MTX MTX Adalimumab Abatacept
Comparator
Arms . 7.5 mg q.d. . 15 mg q.d. . 15 mg q.d. . 15 mg q.d. . 15 mg q.d. . 15 mg q.d.
(Japan) . 30 mg q.d. . Placebo . 30 mg q.d. . 30 mg q.d. . ABA
. 15 mg q.d. . MTX . ADA . Placebo . Placebo
. 30 mg q.d.
. MTX
Primary end . ACR 50 . ACR 20 . ACR 20 . ACR 20 . ACR 20 . Change DAS
point . DAS28 CPR . DAS28 CPR . DAS28 CPR . DAS28 CPR . DAS28 CPR 28 CPR
<2.6 3.2 or less <2.6 3.2 or less 3.2 or less
Statistical Superiority Superiority Non-inferiority/ Superiority Superiority Non-inferiority /
analysis against PBO against PBO superiority against PBO against PBO superiority
UNK Adjusted for Adjusted for Adjusted for Adjusted for UNK
multiplicity multiplicity multiplicity multiplicity
NRI NRI NRI NRI NRI NRI
Resultsa . ACR50 . ACR20 68% . ACR 20 71% . ACR20 64% . ACR20 65% . Change DAS
52.1% UPA UPA vs 41% UPA vs 36% UPA vs36% UPA vs 28 28 CPR
vs 28.3% MTX PBO vs 63% PBO PBO 0.52
PBO . DAS28 CPR ADA . DAS28 CPR . DAS28 CPR (0.69,
. DAS28 CPR 3.2 45% . DAS28 CPR  3.2 48% 3.2 43% 0.35)
< 2.6 48.3% UPA vs 19% <2.6 29% UPA vs 17% UPA vs 14% favours UPA
UPA vs MTX UPA vs 6% PBO PBO
18.5% PBO PBO vs 18%
ADA
Duration of 48 weeks 14 weeks 48 weeks 12 weeks 24 weeks 24 weeks
Period 1
Sample size 975 600 1500 600 450 550
Radiographic Yes Yes
progression

Clinical trials for upadacitinib in RA (SELECT phase III program). aResults are reported for the 15 mg dose (approved
dose). ABA: abatacept; ACR: American College of Rheumatology improvement response; ADA: adalimumab; bDMARD: bio-
logical DMARD; bDMARD IR: biological DMARD insufficient response; csDMARD: conventional synthetic DMARD;
csDMARD IR: conventional synthetic DMARD insufficient response; DAS28(CRP): 28-joint disease activity score using CRP;
MTX-IR: MTX insufficient response; NRI: non-respond imputation; PBO: placebo; q.d.: once daily; UNK: unknown; UPA:
upadacitinib.

Upadacitinib As combination therapy after inadequate response

to cs/bDMARDs
The SELECT Phase III program in RA included six global
The SELECT NEXT study was a randomized double-
phase III studies (Table 1). The favourable data on clinic-
blind, placebo-controlled trial (RCT) of 661 patients with
al efficacy and the acceptable benefit risk profile
active RA with an inadequate response to csDMARDs.
allowed the approval of UPA 15 mg once a day (qd) by
RF or anti-citrullinated protein antibody (ACPA) was
the United States Food and Drug Administration and the
positive in 80% of the patients, 7.3 years was the mean
European Medicines Agency for the treatment of moder-
time since the diagnosis and patients had high disease
ate to severe RA either as monotherapy or in combin-
activity with mean 28-joint disease activity score using
ation with conventional synthetic DMARD (csDMARDs)
CRP [DAS28 (CRP)] of 5.6, mean clinical disease activity
for patients who failed MTX. One of the strengths of the
index (CDAI) of 38.2, mean swollen joint count (SJC66)
SELECT studies was the statistical analysis that was
of 15.8 and mean tender joint count (TJC68) of 25.4.
used in data evaluation, like the adjustment for multipli-
Patients receiving stable background csDMARDs were
city and the non-responder imputation. There were also
assigned to UPA 15 or 30 mg, or placebo (PBO), for
two studies that have demonstrated non-inferiority/su-
12 weeks. The primary endpoints were the proportion of
periority of upadacitinib when compared with another
patients at week 12 who achieved 20% improvement in
biological DMARD (bDMARD).
American College of Rheumatology criteria (ACR20), and

ii18 https://academic.oup.com/rheumatology
 Phase III trials of JAK1 inhibitors in RA

DAS28[CRP] of 3.2 or less. At week 12, ACR20 was As monotherapy in methotrexate-naıve patients
achieved by 141 (64%; 95% CI: 58, 70) of 221 patients The SELECT EARLY study compared the clinical effi-
receiving UPA 15 mg and 145 (66%; 60, 73) of 219 cacy of UPA monotherapy vs MTX monotherapy, in
patients receiving UPA 30 mg, compared with 79 (36%; MTX-naı̈ve patients with moderate to severely active RA.
29, 42) of 221 patients receiving PBO (P <0.0001 for Patients (n ¼ 94) were positive for both RF and ACPA
each dose vs PBO). DAS28[CRP] of 3.2 or less was met and/or had 1 joint erosion. Patients were randomized
by 107 (48%; 95% CI: 42, 55) patients receiving UPA to UPA 15 mg or 30 mg, or weekly MTX (titrated by
15 mg and 105 (48%; 41, 55) patients receiving UPA week 8). Separate primary endpoints were ACR50 at
30 mg, compared with 38 (17%; 12, 22) patients receiv- week 12 or the proportion of patients achieving DAS
ing PBO (P < 0.0001 for each dose vs placebo). 28[CRP] <2.6 at week 24. Significantly more patients
Upadacitinib 30 mg seemed to provide only a minimal receiving UPA 15 mg and 30 mg vs MTX achieved
increase in some efficacy measures [ACR 70, simplified ACR50 responses at week 12 (52.1% and 56.4% vs
disease activity index (SDAI) and CDAI low disease ac- 28.3%) and DAS28[CRP] <2.6 at week 24 (48.3% and
tivity when compared with the 15 mg dose] [3]. 50.0% vs 18.5%) [6].
SELECT BEYOND was a RCT trial that included 499
patients with RA previously inadequate responders or in- Compare to adalimumab
tolerant to bDMARDs. Patients had long-standing estab-
The SELECT COMPARE study evaluated the efficacy of
lished disease with mean duration since diagnosis of
UPA as compared with PBO or adalimumab (ADA) in
13.2 years and had high disease activity, with a mean
MTX inadequate response patients. Patients included
DAS28[CRP] of 5.8, TJC68 of 27.9 and SJC66 of 16.8.
(n ¼ 1629) had active disease and the mean duration of
Patients were assigned to receive UPA 15 mg or 30 mg
RA since diagnosis was 8 years. Most of the patients
or PBO for 12 weeks, followed by UPA 15 mg or 30 mg
(87.5%) were positive for either RF and/or ACPA. They
from week 12 onwards. Both doses of UPA led to rapid
were randomized to receive UPA 15 mg, placebo, or ADA
and significant improvements compared with PBO over
(40 mg every other week) while continuing to take a sta-
12 weeks in patients with refractory RA. ACR20 (primary
ble background dose of MTX. This study was designed
end point) was achieved by 106 (65%; 95% CI: 57, 72)
and powered for superiority against placebo, and to test
of 164 patients receiving UPA 15 mg and 93 (56%; 49,
for the noninferiority and then if achieved, superiority of
64) of 165 patients receiving UPA 30 mg compared with
UPA compared with ADA, as measured both clinically
48 (28%; 22, 35) of 169 patients receiving PBO
and functionally. At week 12, both primary end points
(P < 0.0001 for each dose vs placebo). DAS28[CRP] of
(ACR20 improvement and DAS28[CRP] score <2.6) were
3.2 or less (primary end point) was achieved by 71
met in patients receiving UPA compared with those
(43%; 95% CI: 36, 51) of 164 patients receiving UPA
receiving PBO (P  0.001). Upadacitinib was superior to
15 mg and 70 (42%; 35, 50) of 165 patients receiving
ADA based on the ACR50 response rate, change in pain
UPA 30 mg vs 24 (14%; 9, 20) of 169 patients receiving
severity score, and change in the HAQ Disability Index
PBO (P < 0.0001 for each dose vs PBO) [4].
(HAQ DI). At week 26, more patients receiving UPA than
those receiving PBO or ADA achieved low disease activ-
As monotherapy after inadequate response to ity or remission (P  0.001) [7].
methotrexate SELECT COMPARE STUDY, over 48 weeks, demon-
Upadacitinib monotherapy showed statistically significant strated that the responses were maintained with UPA
improvements in clinical and functional outcomes vs con- treatment over 48 weeks and were consistently signifi-
tinuing MTX in the SELECT MONOTHERAPY study. cantly better than with ADA. Patients who failed to
Patients with active RA (n ¼ 648) despite stable MTX were achieve 20% improvement in TJC with ADA or UPA
randomly assigned to switch to once-daily monotherapy were switched to the other drug. A total of 251 patients
of UPA 15 mg or 30 mg or to continue MTX at their exist- (38.6%) were rescued to ADA vs 159 (48.6%) to upada-
ing dose as blinded study drug. Starting from week 14, citinib. Following 6 months of switch treatment in
patients assigned to continue MTX were switched to UPA patients rescued from adalimumab to UPA, CDAI remis-
15 mg or 30 mg. Patients were ACPA or RF positive in sion/low disease activity was achieved by 15/53% and
79% and had high disease activity. At week 14, an DAS28[CRP] <2.6/3.2 by 35/56%; in patients rescued
ACR20 response (primary end point) was achieved by 89 from UPA to ADA, CDAI remission/low disease activity
(41%) of 216 patients (95% CI: 35, 48) in the continued was achieved in 5/41% and DAS28[CRP] <2.6/3.2
MTX group, 147 (68%) of 217 patients (62, 74) receiving was achieved in 21/40% [8]. This is the first data to as-
UPA 15 mg, and 153 (71%) of 215 patients (65, 77) receiv- sess the response on patients who failed to respond to
ing upadacitinib 30 mg (P < 0.0001 for both doses vs con- JAKi and were switched to TNFi.
tinued MTX). DAS28[CRP] 3.2 or lower (primary end point)
was met by 42 (19%) of 216 (95% CI: 14, 25) in the con- Compare to abatacept in patients with prior
tinued MTX group, 97 (45%) of 217 (38, 51) receiving UPA inadequate response to biologic therapy
15 mg, and 114 (53%) of 215 (46, 60) receiving UPA The SELECT-CHOICE was a head-to-head phase 3,
30 mg (P < 0.0001 for both doses vs continued MTX) [5]. double-blind study in bDMARD-IR patients comparing

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Eduardo Mysler and Ana Lizarraga

the efficacy and safety of UPA to abatacept (ABA), each Patients’ reported outcomes
in combination with stable background csDMARDs. The In the SELECT program, patients’ reported outcomes
study included 613 patients, with long-standing estab- such as pain, physical function assessment (HAQ-DI),
lished and active disease, who were randomized to UPA fatigue (FACIT-F) and quality-of-life (SF-36 PCS) were
15 mg q.d. or intravenous ABA in standard doses. The also significantly improved in patients treated with UPA
primary end point was the non-inferiority comparison of vs PBO [3–8]. The effect of UPA on morning stiffness
UPA to ABA in change from baseline in DAS28[CRP] at was seen early. In the SELECT NEXT study by week 1,
week 12. The ranked key secondary endpoints were the the severity of morning stiffness was significantly
superiority comparison of UPA to ABA in change from improved for patients receiving either 15 or 30 mg com-
baseline in DAS28(CRP) at week 12 and the superiority pared with PBO (P < 0.0001), and improvements contin-
comparison of UPA to ABA in proportion of patients ued over the 12 weeks [3]. In the SELET COMPARE
achieving clinical remission based on DAS28(CRP) at study, UPA was superior to ADA based on the change
week 12. in pain severity score [mean change 32.1 in the UPA
UPA met the primary end point of non-inferiority vs group vs 25.6 in the ADA group, difference 6.5 (95%
ABA for change from baseline in DAS28(CRP) CI: 9.7, 3.3); P  0.001] and change in HAQ DI score
(P < 0.001) and shown to be superior to ABA for change [mean change 0.60 in the UPA group vs 0.49 in the
from baseline in DAS28(CRP) (P < 0.001) and proportion ADA group, difference 0.11 (95% CI 0.18, 0.03);
of patients achieving DAS28(CRP) <2.6 remission P  0.01]. These improvements were maintained
(P < 0.001) at week 12. A significant difference in the through 26 weeks [7].
proportion of patients achieving DAS28(CRP) <2.6 was
also maintained at week 24 [9]. The SELECT-CHOICE is
the first study demonstrating the superiority of a select- Filgotinib
ive JAK inhibitor compared with a standard of care bio-
logic in a population of RA patients with a prior The development of filgotinib included four phase III
inadequate response to a biologic therapy. clinical trials, the FINCH phase III program (Table 2).
Results from some of the studies have been recently
published but still there is a lot of information expected
Radiographic responses
to be presented soon. The long-term extension study is
The impact of upadacitinib on structural joint damage still ongoing.
was assessed during SELECT EARLY and SELECT
COMPARE. In the SELECT EARLY trial, at week 24, As combination therapy after inadequate response
both doses of UPA monotherapy significantly reduced to methotrexate
progression of joint damage as determined by signifi-
The FINCH 1 study was a double blind RCT. MTX-IR
cantly lower change from baseline in modified Total
patients with active RA on background stable MTX were
Sharp Score (mTSS) compared with MTX (DmTSS UPA
randomized to oral filgotinib 200 mg or filgotinib 100 mg
15 mg: 0.03; UPA 30 mg: 0.10; MTX: 0.66; P < 0.001 once daily, subcutaneous adalimumab 40 mg every
both doses). At week 48, both doses of UPA monother- 2 weeks, or matching placebo up to week 52. Patients
apy continued to significantly reduce progression of joint receiving placebo at week 24 were re-randomized to re-
damage compared with MTX [6, 10]. In the SELECT ceive filgotinib. The primary end point was the propor-
COMPARE trial, at week 26, UPA 15 mg þ MTX signifi- tion of participants who achieve an ACR 20% at week
cantly reduced progression of joint damage as deter- 12. A total of 1417 patients received study drug through
mined by significantly lower change from baseline in week 52. Most of the patients had long-standing dis-
mTSS compared with PBO þ MTX [DmTSS UPA 15 mg ease (mean 7.8 years if diagnosis), 85.3% were RF or
þ MTX: 0.16; ADA þ MTX: 0.19; PBO þ MTX: 0.94; anti CCP positive and have active disease (mean DAS28
P < 0.001 (vs PBO þ MTX)]. The change from baseline CPR 5.7). A significantly greater proportion of patients
for UPA 15 mg þ MTX was similar to that for ADA þ treated with filgotinib 200 or 100 mg achieved ACR 20 at
MTX. At week 48, the UPA 15 mg þ MTX continued to week 12 compared with placebo (76.6%, 69.8%, 49.9%
significantly reduce progression of joint damage [7, 10]. respectively, P < 0.001). The proportion of patients
Two years’ data was recently presented. In the achieving DAS28(CPR) <2.6 at week 52 was 54%, 43%
SELECT EARLY, UPA monotherapy (both doses) contin- and 46% for patients receiving filgotinib 200 mg, filgoti-
ued to demonstrate reduced progression of structural nib 100 mg, and adalimumab, respectively (nominal P for
joint damage compared with MTX monotherapy; and in filgotinib 200 mg vs adalimumab ¼ 0.024). Non-inferiority
the SELECT COMPARE study, the rate of inhibition of of FIL 200 mg to ADA was met based on DAS28-CRP
structural progression observed was similar between 3.2. Response rates were numerically similar between
continuous administration of UPA þ MTX or ADA þ patients treated with filgotinib 100 mg vs adalimumab.
MTX as measured by a mean change from baseline in Radiographic progression measured by change from
mTSS. Following the switch of PBO patients to UPA baseline in mTSS vs placebo at week 24 was signifi-
15 mg, no further radiographic progression was cantly less in filgotinib 200 mg or 100 mg vs placebo
observed in almost 90% of patients [11]. (P < 0.001 and P ¼ 0.001, respectively). Overall,

ii20 https://academic.oup.com/rheumatology
 Phase III trials of JAK1 inhibitors in RA

TABLE 2 FINCH phase III studies

Study FINCH 1 FINCH 2 FINCH 3 FINCH 4

Population MTX IR bDMARD IR MTX naive LTE

Type of therapy Combo Combo Mono vs Combo Combo
Background MTX csDMARDs MTX csDMARDs
Active comparator ADA csDMARs MTX
Arms . FIL 200 mg QD þ . FIL 200 mg QD þ . FIL 200 mg QD þ . FIL 200 mg QD
MTX csDMARDs MTX . FIL 100 mg QD
. FIL 100 mg QD þ . FIL 100 mg QD þ . FIL 100 mg QD þ
MTX csDMARDs MTX
. ADA þMTX .  PBO þ . FIL 200 mg
.  PBO þMTX for csDMARDs . PBO þMTX
24 weeks followed
by FIL 100 mg or
200 mg þMTX
Primary end point ACR 20 ACR 20 ACR 20 Safety
Statistical analysis Non inferiority Superiority against Superiority against
PBO PBO
Not adjusted for Not adjusted for Not adjusted for
multiplicity multiplicity multiplicity
NRI NRI NRI
Results ACR20 76.6% FIL ACR20 66% FIL ACR20 81% FIL
200 mg, 77.7% FIL 200 ng, 57.5% FIL 200 mg, 80.2% FIL
100 mg vs 49.9% 100 mg vs 31.1% 100 mg vs 71.4%
PBO PBO MTX
Duration of Period 1 12 weeks 24 weeks 26 weeks 78 weeks
Sample size 1759 449 1552 2800
Radiographic Yes Yes
progression

Clinical Trials for Filgotinib in RA (FINCH phase III program). ACR: American College of Rheumatology improvement re-
sponse; ADA: adalimumab; bDMARD: biological DMARD; bDMARD IR: biological DMARD insufficient response; csDMARD:
conventional synthetic DMARD; csDMARD IR: conventional synthetic DMARD insufficient response; FIL: filgotinib; LTE:
Long term extension; MTX-IR: MTX insufficient response; NRI: non-responder imputation; PBO: placebo; QD: once daily.

filgotinib demonstrated a favourable benefit-risk profile numerically higher compared with the 100 mg dose,
in MTX IR patients with AR [12, 13]. but no statistical analysis for potential dose response
was done. There were no radiographic end points to
evaluate structural joint damage [14].
As combination therapy after inadequate response
to bDMARDs Methotrexate-naıve patients
The FINCH 2 study compared the effects of filgotinib The FINCH 3 trial included MTX naive patients with ac-
vs placebo for the treatment of patients with moder- tive RA, randomized to oral filgotinib 200 mg once daily
ately to severely active RA and an inadequate re- plus MTX, filgotinib 100 mg plus MTX, filgotinib 200 mg
sponse or intolerance to 1 or more prior bDMARDs. monotherapy and MTX 20 mg weekly. The primary ef-
Patients were randomized to once daily filgotinib ficacy end point was proportion of patients achieving
200 mg; filgotinib 100 mg; or placebo. In total, 449 ACR20 response at week 24. In total, 1249 received
patients were included. At week 12, the ACR20 re- the study drug and were analysed; 1130 completed
sponse rates (primary end point) were 66.0% (95% week 24. 77% of patients were RF or anti CCP positive
CI: 58.0%, 74.0%) and 57.5% (95% CI: 49.4%, and 94% of patients had at least one erosion; mean
65.7%) for filgotinib 200 mg and 100 mg, respectively, time since RA diagnosis was 2.2 years (median
vs 31.1% (95% CI: 23.3%, 38.9%) for placebo [differ- 0.4 years); mean (S.D.) DAS28-CRP was 5.7 (1.0); and
ence vs placebo: 34.9% (95% CI: 23.5%, 46.3%) for 35.9% were using oral steroids at baseline. At week
filgotinib 200 mg, and 26.4% (95% CI: 15.0%, 37.9%) 24, significantly more patients in the FIL 200 mg þ MTX
for filgotinib 100 mg; both P < 0.001]. At week 24, (81.0%; P < 0.001) and FIL 100 mg þ MTX (80.2%;
30.6% of patients treated with filgotinib 200 mg, P < 0.05) arms achieved an ACR20 response com-
achieved disease remission (DAS28-CRP <2.6). pared with MTX monotherapy (71.4%). In the mono-
Responses with the filgotinib 200 mg dose were therapy arm, a higher proportion of patients achieved

https://academic.oup.com/rheumatology ii21
Eduardo Mysler and Ana Lizarraga

ACR 50/70 with filgotinib 200 mg vs MTX, though ACR InSight: The related InSight paper for this supplement can
20 response was not significantly higher at week 24. be accessed at https://academic.oup.com/rheumatology/
Filgotinib efficacy was sustained through week 52. article-lookup/doi/10.1093/rheumatology/keab341.
There was less radiographic progression as measured
by change in mTSS from baseline at week 52 in
patients receiving filgotinib 100/200 mg vs MTX mono-
therapy [15, 16]. Data availability statement
The FINCH 4 is a study that is evaluating the long- Data are available upon reasonable request by any
term safety and tolerability of filgotinib in participants qualified researchers who engage in rigorous, independ-
who have completed one of the parent studies of filgoti- ent scientific research, and will be provided following re-
nib in RA. The study is still active and partial results are view and approval of a research proposal and Statistical
expected soon [17]. Analysis Plan (SAP) and execution of a Data Sharing
Agreement (DSA). All data relevant to the study are
included in the article.

Conclusion
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Funding: This paper was published as part of a supple- 8 Fleischmann RM, Genovese MC, Enejosa JV et al. Safety
ment supported by an educational grant from Gilead. and effectiveness of upadacitinib or adalimumab plus
methotrexate in patients with rheumatoid arthritis over 48
Disclosure statement: E.M. speaker bureau and advisor weeks with switch to alternate therapy in patients with
for AbbVie, Pfizer, Roche, GSK, Janssen, Sanofi, insufficient response. Ann Rheum Dis 2019;78:1454–62.
Sandoz, Gemma, BMS, Astra Zeneca, Lilly. Grants to 9 Rubbert-Roth A, Enejosa J, Pangan A et al. Trial of
the institution from AbbVie, Pfizer, Roche, Sanofi, GSK. Upadacitinib or Abatacept in Rheumatoid Arthritis. N Eng
A.L. has no conflicts. J Med 2020;383:1511–21.

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