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IMPORTANT SAFETY INFORMATION
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SERIOUS INFECTIONS
PATIENTS TREATED WITH XELJANZ*
ARE AT INCREASED RISK FOR
DEVELOPING SERIOUS INFECTIONS THAT
MAY LEAD TO HOSPITALIZATION OR
DEATH. MOST PATIENTS WHO DEVELOPED
THESE INFECTIONS WERE TAKING
CONCOMITANT IMMUNOSUPPRESSANTS,
SUCH AS METHOTREXATE OR
CORTICOSTEROIDS.
IF A SERIOUS INFECTION DEVELOPS,
INTERRUPT XELJANZ UNTIL THE
INFECTION IS CONTROLLED.
REPORTED INFECTIONS
INCLUDE:
-
ACTIVE TUBERCULOSIS, WHICH
MAY PRESENT WITH PULMONARY OR
EXTRAPULMONARY DISEASE.
PATIENTS
SHOULD BE TESTED FOR LATENT
TUBERCULOSIS BEFORE XELJANZ
USE AND DURING THERAPY.
TREATMENT FOR
LATENT INFECTION SHOULD BE
INITIATED PRIOR TO XELJANZ
USE.
-
INVASIVE FUNGAL INFECTIONS,
INCLUDING CRYPTOCOCCOSIS AND
PNEUMOCYSTOSIS. PATIENTS WITH
INVASIVE FUNGAL INFECTIONS MAY
PRESENT WITH DISSEMINATED,
RATHER THAN LOCALIZED,
DISEASE.
-
BACTERIAL, VIRAL, INCLUDING
HERPES ZOSTER, AND OTHER
INFECTIONS DUE TO OPPORTUNISTIC
PATHOGENS.
Scroll to see additional Important
Safety Information below.
*Unless otherwise stated, “XELJANZ”
in the Important Safety Information
refers to XELJANZ, XELJANZ XR, and
XELJANZ Oral
Solution.
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Dear Healthcare Professional,
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How do robust clinical data and market
experience impact your prescribing
decisions? Below, please find some
information that could be relevant when
treating your patients with RA, PsA, AS,
and pcJIA.
See full
Indication with
Limitations
of Use below.
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XELJANZ is indicated in patients who
have had an inadequate response or
intolerance to one or more TNF
blockers: in adults with moderately to
severely active RA, active PsA, active
AS, moderately to severely active UC,
and in patients 2 years of age and
older with active pcJIA.
Use of XELJANZ in combination with
biological therapies or with potent
immunosuppressants is not recommended.
Included studies in patients who have
had an inadequate response or
intolerance to one or more TNF
blockers. Patients in these studies
included adults with moderately to
severely active RA, active PsA, active
AS, moderately to severely active UC,
and in patients with active pcJIA.1
aIQVIA Lifelink Patient Data,
including Rx, Dx, and Specialty
Pharmacy, September 2023 (>272,800
includes >247,100 for RA, >23,300
for PsA, >1600 for AS, and >740
for pcJIA).3
bRepresents patients who
received XELJANZ and completed phase 3
and 3b/4 clinical trials, including
those who were switched to XELJANZ from
placebo. Includes 4799 RA patients
treated with XELJANZ
5 mg BID or
XELJANZ XR 11 mg QD; 338 PsA patients
treated with XELJANZ 5 mg BID; 950 UC
patients treated with XELJANZ 5 mg BID
or 10 mg BID; 264 AS patients treated
with XELJANZ 5 mg BID; and 184 pcJIA
patients treated with XELJANZ 5 mg BID
or XELJANZ Oral Solution (5 mg BID or
body weight-based equivalent dose
BID).3-5,7-17
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IMPORTANT SAFETY INFORMATION
(cont'd)
SERIOUS INFECTIONS (cont'd)
The most common serious infections
reported with XELJANZ included
pneumonia, cellulitis, herpes zoster,
urinary tract infection,
diverticulitis, and appendicitis.
Avoid use of XELJANZ in patients with
an active, serious infection,
including localized infections.
In the UC population, XELJANZ 10 mg
twice daily was associated with
greater risk of serious infections
compared to 5 mg twice daily.
Opportunistic herpes zoster infections
(including meningoencephalitis,
ophthalmologic, and disseminated
cutaneous) were seen in patients who
were treated with XELJANZ 10 mg twice
daily.
THE RISKS AND BENEFITS OF TREATMENT
WITH XELJANZ SHOULD BE CAREFULLY
CONSIDERED PRIOR TO INITIATING
THERAPY IN PATIENTS WITH CHRONIC OR
RECURRENT INFECTION,
or those who have lived or traveled in
areas of endemic TB or mycoses. Viral
reactivation including herpes virus
and hepatitis B reactivation have been
reported. Screening for viral
hepatitis should be performed in
accordance with clinical guidelines
before starting therapy.
PATIENTS SHOULD BE CLOSELY
MONITORED FOR THE DEVELOPMENT OF
SIGNS AND SYMPTOMS OF INFECTION
DURING AND AFTER TREATMENT WITH
XELJANZ, INCLUDING THE POSSIBLE
DEVELOPMENT OF TUBERCULOSIS IN
PATIENTS WHO TESTED NEGATIVE FOR
LATENT TUBERCULOSIS INFECTION PRIOR
TO INITIATING THERAPY.
Caution is also recommended in
patients with a history of chronic
lung disease, or in those who develop
interstitial lung disease, as they may
be more prone to infection.
MORTALITY
IN A LARGE, RANDOMIZED,
POSTMARKETING SAFETY STUDY IN
RHEUMATOID ARTHRITIS (RA) PATIENTS
50 YEARS OF AGE AND OLDER WITH AT
LEAST ONE CARDIOVASCULAR (CV) RISK
FACTOR COMPARING XELJANZ 5 MG TWICE
A DAY OR XELJANZ 10 MG TWICE A DAY
TO TUMOR NECROSIS FACTOR (TNF)
BLOCKERS, A HIGHER RATE OF ALL-CAUSE
MORTALITY, INCLUDING SUDDEN CV
DEATH, WAS OBSERVED WITH XELJANZ 5
MG TWICE A DAY OR XELJANZ 10 MG
TWICE A DAY. A XELJANZ 10 MG TWICE
DAILY (OR A XELJANZ XR 22 MG ONCE
DAILY) DOSAGE IS NOT RECOMMENDED FOR
THE TREATMENT OF RA OR PsA. For UC, use XELJANZ at the lowest
effective dose and for the shortest
duration needed to achieve/maintain
therapeutic response.
MALIGNANCIES
MALIGNANCIES,
INCLUDING LYMPHOMAS AND SOLID
TUMORS, HAVE OCCURRED IN PATIENTS
TREATED WITH XELJANZ AND OTHER JANUS
KINASE INHIBITORS USED TO TREAT
INFLAMMATORY CONDITIONS. IN RA
PATIENTS, A HIGHER RATE OF
MALIGNANCIES (EXCLUDING NMSC) WAS
OBSERVED IN PATIENTS TREATED WITH
XELJANZ 5 MG TWICE A DAY OR XELJANZ
10 MG TWICE A DAY COMPARED WITH TNF
BLOCKERS.
LYMPHOMA AND
LUNG CANCERS WERE OBSERVED AT A
HIGHER RATE IN PATIENTS TREATED WITH
XELJANZ 5 MG TWICE A DAY OR XELJANZ
10 MG TWICE A DAY IN RA PATIENTS
COMPARED TO THOSE TREATED WITH TNF
BLOCKERS. PATIENTS WHO ARE CURRENT
OR PAST SMOKERS ARE AT ADDITIONAL
INCREASED RISK.
EPSTEIN BARR VIRUS-ASSOCIATED
POST-TRANSPLANT LYMPHOPROLIFERATIVE
DISORDER HAS BEEN OBSERVED AT AN
INCREASED RATE IN RENAL TRANSPLANT
PATIENTS TREATED WITH XELJANZ AND
CONCOMITANT IMMUNOSUPPRESSIVE
MEDICATIONS.
Consider the benefits and risks for
the individual patient prior to
initiating or continuing therapy with
XELJANZ, particularly in patients with
a known malignancy (other than a
successfully treated NMSC), patients
who develop a malignancy while on
treatment, and patients who are
current or past smokers. A XELJANZ 10
mg twice daily (or a XELJANZ XR 22 mg
once daily) dosage is not recommended
for the treatment of RA or PsA.
Other malignancies were observed in
clinical studies and the postmarketing
setting including, but not limited to,
lung cancer, breast cancer, melanoma,
prostate cancer, and pancreatic
cancer. NMSCs have been reported in
patients treated with XELJANZ.
Periodic skin examination is
recommended for patients who are at
increased risk for skin cancer. In the
UC population, treatment with XELJANZ
10 mg twice daily was associated with
greater risk of NMSC.
MAJOR ADVERSE CARDIOVASCULAR EVENTS
(MACE)
RA PATIENTS 50 YEARS OF
AGE AND OLDER WITH AT LEAST ONE CV
RISK FACTOR, TREATED WITH XELJANZ 5
MG TWICE DAILY OR XELJANZ 10 MG
TWICE DAILY, HAD A HIGHER RATE OF
MACE (DEFINED AS CARDIOVASCULAR
DEATH, MYOCARDIAL INFARCTION, AND
STROKE), COMPARED TO THOSE TREATED
WITH TNF BLOCKERS. PATIENTS WHO ARE
CURRENT OR PAST SMOKERS ARE AT
ADDITIONAL INCREASED RISK.
DISCONTINUE XELJANZ IN PATIENTS THAT
HAVE EXPERIENCED A MYOCARDIAL
INFARCTION OR STROKE.
Consider the benefits and risks for
the individual patient prior to
initiating or continuing therapy with
XELJANZ, particularly in patients who
are current or past smokers and
patients with other CV risk factors.
Inform patients about the symptoms of
serious CV events. A XELJANZ 10 mg
twice a day (or a XELJANZ XR 22 mg
once daily) dosage is not recommended
for the treatment of RA or PsA.
THROMBOSIS
THROMBOSIS,
INCLUDING PULMONARY EMBOLISM, DEEP
VENOUS THROMBOSIS, AND ARTERIAL
THROMBOSIS, HAVE OCCURRED IN
PATIENTS TREATED WITH XELJANZ AND
OTHER JANUS KINASE INHIBITORS USED
TO TREAT INFLAMMATORY CONDITIONS.
MANY OF THESE EVENTS WERE SERIOUS
AND SOME RESULTED IN DEATH. RA
PATIENTS 50 YEARS OF AGE AND OLDER
WITH AT LEAST ONE CV RISK FACTOR
TREATED WITH XELJANZ 5 MG TWICE
DAILY OR XELJANZ
10 MG TWICE DAILY COMPARED TO TNF
BLOCKERS HAD AN OBSERVED INCREASE IN
INCIDENCE OF THESE EVENTS. AVOID
XELJANZ IN PATIENTS AT RISK.
DISCONTINUE XELJANZ AND PROMPTLY
EVALUATE PATIENTS WITH SYMPTOMS OF
THROMBOSIS.
A XELJANZ 10 mg twice daily (or
XELJANZ XR 22 mg once daily) dosage is
not recommended for the treatment of
RA or PsA. In a long-term extension
study in UC, five cases of pulmonary
embolism were reported in patients
taking XELJANZ 10 mg twice daily,
including one death in a patient with
advanced cancer. For UC, use XELJANZ
at the lowest effective dose and for
the shortest duration needed to
achieve/maintain therapeutic
response.
GASTROINTESTINAL
PERFORATIONS
Gastrointestinal perforations have
been reported in XELJANZ clinical
trials, although the role of JAK
inhibition is not known. In these
studies, many patients with rheumatoid
arthritis were receiving background
therapy with Nonsteroidal
Anti-Inflammatory Drugs (NSAIDs).
There was no discernible difference in
frequency of gastrointestinal
perforation between the placebo and
the XELJANZ arms in clinical trials of
patients with UC, and many of them
were receiving background
corticosteroids. XELJANZ should be
used with caution in patients who may
be at increased risk for
gastrointestinal perforation (e.g.,
patients with a history of
diverticulitis or taking
NSAIDs).
HYPERSENSITIVITY
Angioedema and urticaria that may
reflect drug hypersensitivity have
been observed in patients receiving
XELJANZ and some events were serious.
If a serious hypersensitivity reaction
occurs, promptly discontinue
tofacitinib while evaluating the
potential cause or causes of the
reaction.
LABORATORY ABNORMALITIES
LYMPHOCYTE ABNORMALITIES:
Treatment with XELJANZ was associated
with initial lymphocytosis at one
month of exposure followed by a
gradual decrease in mean lymphocyte
counts. Avoid initiation of XELJANZ
treatment in patients with a count
less than 500 cells/mm3. In
patients who develop a confirmed
absolute lymphocyte count less than
500 cells/mm3, treatment
with XELJANZ is not recommended. Risk
of infection may be higher with
increasing degrees of lymphopenia and
consideration should be given to
lymphocyte counts when assessing
individual patient risk of infection.
Monitor lymphocyte counts at baseline
and every 3 months thereafter.
NEUTROPENIA:
Treatment with XELJANZ was associated
with an increased incidence of
neutropenia (less than 2000
cells/mm3) compared to
placebo. Avoid initiation of XELJANZ
treatment in patients with an ANC less
than 1000 cells/mm3. For
patients who develop a persistent ANC
of 500-1000 cells/mm3,
interrupt XELJANZ dosing until ANC is
greater than or equal to 1000
cells/mm3. In patients who
develop an ANC less than 500
cells/mm3, treatment with
XELJANZ is not recommended. Monitor
neutrophil counts at baseline and
after 4-8 weeks of treatment and every
3 months thereafter.
ANEMIA: Avoid
initiation of XELJANZ treatment in
patients with a hemoglobin level less
than 9 g/dL. Treatment with XELJANZ
should be interrupted in patients who
develop hemoglobin levels less than 8
g/dL or whose hemoglobin level drops
greater than 2 g/dL on treatment.
Monitor hemoglobin at baseline and
after 4-8 weeks of treatment and every
3 months thereafter.
LIVER ENZYME ELEVATIONS:
Treatment with XELJANZ was associated
with an increased incidence of liver
enzyme elevation compared to placebo.
Most of these abnormalities occurred
in studies with background DMARD
(primarily methotrexate) therapy. If
drug-induced liver injury is
suspected, the administration of
XELJANZ should be interrupted until
this diagnosis has been excluded.
Routine monitoring of liver tests and
prompt investigation of the causes of
liver enzyme elevations is recommended
to identify potential cases of
drug-induced liver injury.
LIPID ELEVATIONS:
Treatment with XELJANZ was associated
with dose-dependent increases in lipid
parameters, including total
cholesterol, low-density lipoprotein
(LDL) cholesterol, and high-density
lipoprotein (HDL) cholesterol. Maximum
effects were generally observed within
6 weeks. There were no clinically
relevant changes in LDL/HDL
cholesterol ratios. Manage patients
with hyperlipidemia according to
clinical guidelines. Assessment of
lipid parameters should be performed
approximately 4-8 weeks following
initiation of XELJANZ therapy.
VACCINATIONS
Avoid use of live vaccines
concurrently with XELJANZ. The
interval between live vaccinations and
initiation of tofacitinib therapy
should be in accordance with current
vaccination guidelines regarding
immunosuppressive agents. Update
immunizations in agreement with
current immunization guidelines prior
to initiating XELJANZ therapy.
PATIENTS WITH GASTROINTESTINAL
NARROWING
Caution should be used when
administering XELJANZ XR to patients
with pre-existing severe
gastrointestinal narrowing. There have
been rare reports of obstructive
symptoms in patients with known
strictures in association with the
ingestion of other drugs utilizing a
non-deformable extended-release
formulation.
HEPATIC AND RENAL
IMPAIRMENT
Use of XELJANZ in patients with
severe hepatic impairment is not
recommended. For patients with
moderate hepatic impairment or with
moderate or severe renal impairment
taking XELJANZ 5 mg twice daily or XELJANZ XR 11 mg once daily, reduce
to XELJANZ 5 mg once daily. For UC
patients with moderate hepatic
impairment or with moderate or severe
renal impairment taking XELJANZ 10 mg
twice daily, reduce to XELJANZ 5 mg
twice daily. If taking XELJANZ XR 22
mg once daily, reduce to XELJANZ XR 11
mg once daily.
ADVERSE REACTIONS
The most common serious adverse
reactions were serious infections. The
most commonly reported adverse
reactions during the first 3 months in
controlled clinical trials in patients
with RA with XELJANZ 5 mg twice daily
and placebo, respectively, (occurring
in greater than or equal to 2% of
patients treated with XELJANZ with or
without DMARDs) were upper respiratory
tract infection, nasopharyngitis,
diarrhea, headache, and hypertension.
The safety profile observed in
patients with active PsA treated with
XELJANZ was consistent with the safety
profile observed in RA patients.
Adverse reactions reported in ≥5% of
patients treated with either 5 mg
or
10 mg twice daily of XELJANZ and ≥1%
greater than reported in patients
receiving placebo in either the
induction or maintenance clinical
trials for UC were: nasopharyngitis,
elevated cholesterol levels, headache,
upper respiratory tract infection,
increased blood creatine
phosphokinase, rash, diarrhea, and
herpes zoster.
USE IN PREGNANCY
Available data with XELJANZ use in
pregnant women are insufficient to
establish a drug associated risk of
major birth defects, miscarriage or
adverse maternal or fetal outcomes.
There are risks to the mother and the
fetus associated with rheumatoid
arthritis and UC in pregnancy. In
animal studies, tofacitinib at 6.3
times the maximum recommended dose of
10 mg twice daily demonstrated adverse
embryo-fetal findings. The relevance
of these findings to women of
childbearing potential is uncertain.
Consider pregnancy planning and
prevention for females of reproductive
potential.
INDICATIONS
RHEUMATOID ARTHRITIS
-
XELJANZ/XELJANZ XR is indicated for
the treatment of adult patients with
moderately to severely active
rheumatoid arthritis (RA) who have
had an inadequate response or
intolerance to one or more TNF
blockers.
-
Limitations of Use: Use of
XELJANZ/XELJANZ XR in combination
with biologic disease-modifying
antirheumatic drugs (DMARDs) or with
potent immunosuppressants such as
azathioprine and cyclosporine is not
recommended.
PSORIATIC ARTHRITIS
-
XELJANZ/XELJANZ XR is indicated for
the treatment of adult patients with
active psoriatic arthritis (PsA) who
have had an inadequate response or
intolerance to one or more TNF
blockers.
-
Limitations of Use: Use of
XELJANZ/XELJANZ XR in combination
with biologic DMARDs or with potent
immunosuppressants such as
azathioprine and cyclosporine is not
recommended.
ANKYLOSING SPONDYLITIS
-
XELJANZ/XELJANZ XR is indicated for
the treatment of adult patients with
active ankylosing spondylitis (AS)
who have had an inadequate response
or intolerance to one or more TNF
blockers.
-
Limitations of Use: Use of
XELJANZ/XELJANZ XR in combination
with biologic DMARDs or potent
immunosuppressants such as
azathioprine and cyclosporine is not
recommended.
ULCERATIVE COLITIS
-
XELJANZ/XELJANZ XR is indicated for
the treatment of adult patients with
moderately to severely active
ulcerative colitis (UC), who have
had an inadequate response or
intolerance to one or more TNF
blockers.
-
Limitations of Use: Use of
XELJANZ/XELJANZ XR in combination
with biological therapies for UC or
with potent immunosuppressants such
as azathioprine and cyclosporine is
not recommended.
POLYARTICULAR COURSE JUVENILE
IDIOPATHIC ARTHRITIS
-
XELJANZ/XELJANZ Oral Solution is
indicated for the treatment of
active polyarticular course juvenile
idiopathic arthritis (pcJIA) in
patients 2 years of age and older
who have had an inadequate response
or intolerance to one or more TNF
blockers.
-
Limitations of Use: Use of
XELJANZ/XELJANZ Oral Solution in
combination with biologic DMARDs or
with potent immunosuppressants such
as azathioprine and cyclosporine is
not recommended.
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AS=ankylosing spondylitis; BID=twice
daily; JAKi=Janus kinase inhibitor;
pcJIA=polyarticular course juvenile
idiopathic arthritis; PsA=psoriatic
arthritis; QD=once daily; RA=rheumatoid
arthritis; TNF=tumor necrosis factor;
UC=ulcerative colitis; XR=extended
release.
References: 1. XELJANZ
[prescribing information]. New York, NY:
Pfizer Inc., January 2022.
2. Cohen SB, Tanaka Y,
Mariette X, et al. Long-term safety of
tofacitinib up to 9.5 years: a
comprehensive integrated analysis of the
rheumatoid arthritis clinical
development programme.
RMD Open. 2020;6(3):e001395.
doi:10.1136/rmdopen-2020-001395
3. Data on file. Pfizer
Inc., New York, NY. 4.
Fleischmann R, Mysler E, Hall S, et al;
on behalf of the ORAL Strategy
investigators. Efficacy and safety of
tofacitinib monotherapy, tofacitinib
with methotrexate, and adalimumab with
methotrexate in patients with rheumatoid
arthritis (ORAL Strategy): a phase 3b/4,
double-blind, head-to-head, randomised
controlled trial. Lancet.
2017;390(10093):457-468.
doi:10.1016/S0140-6736(17)31618-5
5. Cohen SB, Pope J,
Haraoui B, et al. Methotrexate
withdrawal in patients with rheumatoid
arthritis who achieve low disease
activity with tofacitinib
modified-release 11 mg once daily plus
methotrexate (ORAL Shift): a randomised,
phase 3b/4, non-inferiority trial.
Lancet Rheumatol. Published
online August 6, 2019.
doi:10.1016/S2665-9913(19)30005-0
Published correction appears in
Lancet Rheumatol. 2019;1:e23-
e24. 6. Ytterberg SR,
Bhatt DL, Mikuls TR, et al; for the ORAL
Surveillance Investigators.
Cardiovascular and cancer risk with
tofacitinib in rheumatoid arthritis.
N Engl J Med.
2022;386(4):316-326.
doi:10.1056/NEJMoa2109927
7. Lee EB, Fleischmann
R, Hall S, et al; for the ORAL Start
Investigators. Tofacitinib versus
methotrexate in rheumatoid arthritis
[supplementary appendix].
N Engl J Med.
2014;370(25):2377-2386. Accessed
December 21, 2023.
http://www.nejm.org/doi/suppl/10.1056/NEJMoa1310476/suppl_file/nejmoa1310476_appendix.pdf
8. Fleischmann R,
Kremer J, Cush J, et al; for the ORAL
Solo Investigators. Placebo-controlled
trial of tofacitinib monotherapy in
rheumatoid arthritis [supplementary
appendix].
N Engl J Med.
2012;367(6):495-507. Accessed December
21, 2023.
https://www.nejm.org/doi/suppl/10.1056/NEJMoa1109071/suppl_file/nejmoa1109071_appendix.pdf
9. van Vollenhoven RF,
Fleischmann R, Cohen S, et al; for the
ORAL Standard Investigators. Tofacitinib
or adalimumab versus placebo in
rheumatoid arthritis [supplementary
index].
N Engl J Med. 2012;367:1-18.
Accessed December 21, 2023.
https://www.nejm.org/doi/suppl/10.1056/NEJMoa1112072/suppl_file/nejmoa1112072_appendix.pdf
10. van der Heijde D,
Tanaka Y, Fleischmann R, et al; and the
ORAL Scan Investigators. Tofacitinib
(CP-690,550) in patients with rheumatoid
arthritis receiving methotrexate:
twelve-month data from a
twenty-four-month phase III randomized
radiographic study.
Arthritis Rheum.
2013;65(3):559-570.
doi:10.1002/art.37815.
11. Kremer J, Li Z-G,
Hall S, et al. Tofacitinib in
combination with nonbiologic
disease-modifying antirheumatic drugs in
patients with active rheumatoid
arthritis: a randomized trial.
Ann Intern Med.
2013;159(4):253-261.
doi:10.7325/0003-4819-159-4-201308200-00005
12. Burmester GR,
Blanco R, Charles-Schoeman C, et al; on
behalf of the ORAL Step Investigators.
Tofacitinib (CP-690,550) in combination
with methotrexate in patients with
active rheumatoid arthritis with an
inadequate response to tumour necrosis
factor inhibitors: a randomised phase 3
trial. Lancet.
2013;381(9865):451-460.
doi:10.1015/S0140-5735(12)51424-X
13. Mease P, Hall S,
FitzGerald O, et al. Tofacitinib or
adalimumab versus placebo for psoriatic
arthritis. N Engl J Med.
2017;377(16):1537-1550.
doi:10.1055/NEJMoa1515975
14. Gladman D, Rigby W,
Azevedo VF, et al. Tofacitinib for
psoriatic arthritis in patients with an
inadequate response to TNF
inhibitors. N Engl J Med.
2017;377(16):1525-1536.
doi:10.1056/NEJMoa1615977
15. Deodhar A,
Sliwinska-Stanczyk P, Xu H, et al.
Tofacitinib for the treatment of
ankylosing spondylitis: a phase III,
randomised, double-blind,
placebo-controlled study.
Ann Rheum Dis.
2021;80(8):1004-1013. doi:10.1135/
annrheumdis-2020-219601
16. Sandborn WJ, Su C,
Sands BE, et al; for the OCTAVE
Induction 1, OCTAVE Induction 2, and
OCTAVE Sustain Investigators.
Tofacitinib as induction and maintenance
therapy for ulcerative colitis
[supplementary appendix].
N Engl J Med.
2017;376(18):1723-1736, 1-77. Accessed
December 21, 2023.
https://www.nejm.org/doi/suppl/10.1056/NEJMoa1606910/suppl_file/nejmoa1606910_appendix.pdf
17. Ruperto N, Brunner
HI, Synoverska O, et al; on behalf of
the Paediatric Rheumatology
International Trials Organisation
(PRINTO) and Pediatric Rheumatology
Collaborative Study Group (PRCSG).
Tofacitinib in juvenile idiopathic
arthritis: a double-blind,
placebo-controlled, withdrawal phase 3
randomised trial. Lancet.
2021;398(10315):1984-1996.
doi:101015/50140-5735(21)01255-1
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Pfizer
P.O. Box 29180
Mission, KS 66201
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This information is intended only for
health care professionals in the
United States.
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Patients should always ask their
doctors for medical advice about
adverse events. You are encouraged to
report adverse events related to
Pfizer products by calling
1-800-438-1985
(U.S. only). If you prefer, you may
contact the U.S. Food and Drug
Administration (FDA) directly. Visit
www.fda.gov/MedWatch
or
call 1-800-FDA-1088.
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