Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials
Identifieur interne : 004247 ( Ncbi/Curation ); précédent : 004246; suivant : 004248Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials
Auteurs : Stanley B. Cohen [États-Unis] ; Yoshiya Tanaka [Japon] ; Xavier Mariette [France] ; Jeffrey R. Curtis [États-Unis] ; Eun Bong Lee [Corée du Sud] ; Peter Nash [Australie] ; Kevin L. Winthrop [États-Unis] ; Christina Charles-Schoeman [États-Unis] ; Krishan Thirunavukkarasu [Australie] ; Ryan Demasi [États-Unis] ; Jamie Geier [États-Unis] ; Kenneth Kwok [États-Unis] ; Lisy Wang [États-Unis] ; Richard Riese [États-Unis] ; Jürgen Wollenhaupt [Allemagne]Source :
- Annals of the Rheumatic Diseases [ 0003-4967 ] ; 2017.
Descripteurs français
- KwdFr :
- Adolescent, Adulte, Adulte d'âge moyen, Essais cliniques comme sujet, Facteurs temps, Femelle, Humains, Incidence, Infection (immunologie), Infection (épidémiologie), Infection (étiologie), Infections opportunistes (immunologie), Infections opportunistes (épidémiologie), Infections opportunistes (étiologie), Inhibiteurs de protéines kinases (effets indésirables), Jeune adulte, Mâle, Pipéridines (effets indésirables), Polyarthrite rhumatoïde (traitement médicamenteux), Pyrimidines (effets indésirables), Pyrroles (effets indésirables), Sujet immunodéprimé, Sujet âgé, Sujet âgé de 80 ans ou plus, Tuberculose (immunologie), Tuberculose (épidémiologie), Tuberculose (étiologie), Tumeurs (immunologie), Tumeurs (épidémiologie), Tumeurs (étiologie), Zona (immunologie), Zona (épidémiologie), Zona (étiologie).
- MESH :
- effets indésirables : Inhibiteurs de protéines kinases, Pipéridines, Pyrimidines, Pyrroles.
- immunologie : Infection, Infections opportunistes, Tuberculose, Tumeurs, Zona.
- traitement médicamenteux : Polyarthrite rhumatoïde.
- épidémiologie : Infection, Infections opportunistes, Tuberculose, Tumeurs, Zona.
- étiologie : Infection, Infections opportunistes, Tuberculose, Tumeurs, Zona.
- Adolescent, Adulte, Adulte d'âge moyen, Essais cliniques comme sujet, Facteurs temps, Femelle, Humains, Incidence, Jeune adulte, Mâle, Sujet immunodéprimé, Sujet âgé, Sujet âgé de 80 ans ou plus.
English descriptors
- KwdEn :
- Adolescent, Adult, Aged, Aged, 80 and over, Arthritis, Rheumatoid (drug therapy), Clinical Trials as Topic, Female, Herpes Zoster (epidemiology), Herpes Zoster (etiology), Herpes Zoster (immunology), Humans, Immunocompromised Host, Incidence, Infection (epidemiology), Infection (etiology), Infection (immunology), Male, Middle Aged, Neoplasms (epidemiology), Neoplasms (etiology), Neoplasms (immunology), Opportunistic Infections (epidemiology), Opportunistic Infections (etiology), Opportunistic Infections (immunology), Piperidines (adverse effects), Protein Kinase Inhibitors (adverse effects), Pyrimidines (adverse effects), Pyrroles (adverse effects), Time Factors, Tuberculosis (epidemiology), Tuberculosis (etiology), Tuberculosis (immunology), Young Adult.
- MESH :
- chemical , adverse effects : Piperidines, Protein Kinase Inhibitors, Pyrimidines, Pyrroles.
- drug therapy : Arthritis, Rheumatoid.
- epidemiology : Herpes Zoster, Infection, Neoplasms, Opportunistic Infections, Tuberculosis.
- etiology : Herpes Zoster, Infection, Neoplasms, Opportunistic Infections, Tuberculosis.
- immunology : Herpes Zoster, Infection, Neoplasms, Opportunistic Infections, Tuberculosis.
- Adolescent, Adult, Aged, Aged, 80 and over, Clinical Trials as Topic, Female, Humans, Immunocompromised Host, Incidence, Male, Middle Aged, Time Factors, Young Adult.
Abstract
Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We report an integrated safety summary of tofacitinib from two phase I, nine phase II, six phase III and two long-term extension studies in adult patients with active RA.
Data were pooled for all tofacitinib-treated patients (data cut-off: 31 March 2015). Incidence rates (IRs; patients with event/100 patient-years) and 95% CIs are reported for adverse events (AEs) of interest.
6194 patients received tofacitinib for a total 19 406 patient-years' exposure; median exposure was 3.4 patient-years. IR (95% CI) for serious AEs was 9.4 (9.0 to 9.9); IR for serious infections was 2.7 (2.5 to 3.0). IR for (all) herpes zoster was 3.9 (3.6 to 4.2); IR for disseminated or multidermatomal herpes zoster was 0.3 (0.2 to 0.4). IR for opportunistic infections (excluding tuberculosis) was 0.3 (0.2 to 0.4) and was 0.2 (0.1 to 0.3) for tuberculosis. IR for malignancies (excluding non-melanoma skin cancer (NMSC)) was 0.9 (0.8 to 1.0); NMSC IR was 0.6 (0.5 to 0.7). IR for gastrointestinal perforations was 0.1 (0.1 to 0.2). Analysis of IR for serious infections, herpes zoster and malignancies by 6-month intervals did not reveal any notable increase in IR with longer-duration tofacitinib exposure.
This analysis of tofacitinib exposure up to 8.5 years allowed estimation of safety events with improved precision versus previous tofacitinib reports. AEs were generally stable over time; no new safety signals were observed compared with previous tofacitinib reports.
Url:
DOI: 10.1136/annrheumdis-2016-210457
PubMed: 28143815
PubMed Central: 5530353
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PMC:5530353Le document en format XML
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials</title>
<author><name sortKey="Cohen, Stanley B" sort="Cohen, Stanley B" uniqKey="Cohen S" first="Stanley B" last="Cohen">Stanley B. Cohen</name>
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<country xml:lang="fr">États-Unis</country>
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<author><name sortKey="Charles Schoeman, Christina" sort="Charles Schoeman, Christina" uniqKey="Charles Schoeman C" first="Christina" last="Charles-Schoeman">Christina Charles-Schoeman</name>
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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<author><name sortKey="Thirunavukkarasu, Krishan" sort="Thirunavukkarasu, Krishan" uniqKey="Thirunavukkarasu K" first="Krishan" last="Thirunavukkarasu">Krishan Thirunavukkarasu</name>
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<author><name sortKey="Geier, Jamie" sort="Geier, Jamie" uniqKey="Geier J" first="Jamie" last="Geier">Jamie Geier</name>
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<author><name sortKey="Wollenhaupt, Jurgen" sort="Wollenhaupt, Jurgen" uniqKey="Wollenhaupt J" first="Jürgen" last="Wollenhaupt">Jürgen Wollenhaupt</name>
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<term>Arthritis, Rheumatoid (drug therapy)</term>
<term>Clinical Trials as Topic</term>
<term>Female</term>
<term>Herpes Zoster (epidemiology)</term>
<term>Herpes Zoster (etiology)</term>
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<term>Infection (etiology)</term>
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<term>Neoplasms (etiology)</term>
<term>Neoplasms (immunology)</term>
<term>Opportunistic Infections (epidemiology)</term>
<term>Opportunistic Infections (etiology)</term>
<term>Opportunistic Infections (immunology)</term>
<term>Piperidines (adverse effects)</term>
<term>Protein Kinase Inhibitors (adverse effects)</term>
<term>Pyrimidines (adverse effects)</term>
<term>Pyrroles (adverse effects)</term>
<term>Time Factors</term>
<term>Tuberculosis (epidemiology)</term>
<term>Tuberculosis (etiology)</term>
<term>Tuberculosis (immunology)</term>
<term>Young Adult</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Adolescent</term>
<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Essais cliniques comme sujet</term>
<term>Facteurs temps</term>
<term>Femelle</term>
<term>Humains</term>
<term>Incidence</term>
<term>Infection (immunologie)</term>
<term>Infection (épidémiologie)</term>
<term>Infection (étiologie)</term>
<term>Infections opportunistes (immunologie)</term>
<term>Infections opportunistes (épidémiologie)</term>
<term>Infections opportunistes (étiologie)</term>
<term>Inhibiteurs de protéines kinases (effets indésirables)</term>
<term>Jeune adulte</term>
<term>Mâle</term>
<term>Pipéridines (effets indésirables)</term>
<term>Polyarthrite rhumatoïde (traitement médicamenteux)</term>
<term>Pyrimidines (effets indésirables)</term>
<term>Pyrroles (effets indésirables)</term>
<term>Sujet immunodéprimé</term>
<term>Sujet âgé</term>
<term>Sujet âgé de 80 ans ou plus</term>
<term>Tuberculose (immunologie)</term>
<term>Tuberculose (épidémiologie)</term>
<term>Tuberculose (étiologie)</term>
<term>Tumeurs (immunologie)</term>
<term>Tumeurs (épidémiologie)</term>
<term>Tumeurs (étiologie)</term>
<term>Zona (immunologie)</term>
<term>Zona (épidémiologie)</term>
<term>Zona (étiologie)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Piperidines</term>
<term>Protein Kinase Inhibitors</term>
<term>Pyrimidines</term>
<term>Pyrroles</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Arthritis, Rheumatoid</term>
</keywords>
<keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Inhibiteurs de protéines kinases</term>
<term>Pipéridines</term>
<term>Pyrimidines</term>
<term>Pyrroles</term>
</keywords>
<keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Herpes Zoster</term>
<term>Infection</term>
<term>Neoplasms</term>
<term>Opportunistic Infections</term>
<term>Tuberculosis</term>
</keywords>
<keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Herpes Zoster</term>
<term>Infection</term>
<term>Neoplasms</term>
<term>Opportunistic Infections</term>
<term>Tuberculosis</term>
</keywords>
<keywords scheme="MESH" qualifier="immunologie" xml:lang="fr"><term>Infection</term>
<term>Infections opportunistes</term>
<term>Tuberculose</term>
<term>Tumeurs</term>
<term>Zona</term>
</keywords>
<keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Herpes Zoster</term>
<term>Infection</term>
<term>Neoplasms</term>
<term>Opportunistic Infections</term>
<term>Tuberculosis</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Polyarthrite rhumatoïde</term>
</keywords>
<keywords scheme="MESH" qualifier="épidémiologie" xml:lang="fr"><term>Infection</term>
<term>Infections opportunistes</term>
<term>Tuberculose</term>
<term>Tumeurs</term>
<term>Zona</term>
</keywords>
<keywords scheme="MESH" qualifier="étiologie" xml:lang="fr"><term>Infection</term>
<term>Infections opportunistes</term>
<term>Tuberculose</term>
<term>Tumeurs</term>
<term>Zona</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adolescent</term>
<term>Adult</term>
<term>Aged</term>
<term>Aged, 80 and over</term>
<term>Clinical Trials as Topic</term>
<term>Female</term>
<term>Humans</term>
<term>Immunocompromised Host</term>
<term>Incidence</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Time Factors</term>
<term>Young Adult</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Adolescent</term>
<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Essais cliniques comme sujet</term>
<term>Facteurs temps</term>
<term>Femelle</term>
<term>Humains</term>
<term>Incidence</term>
<term>Jeune adulte</term>
<term>Mâle</term>
<term>Sujet immunodéprimé</term>
<term>Sujet âgé</term>
<term>Sujet âgé de 80 ans ou plus</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><sec><title>Objectives</title>
<p>Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We report an integrated safety summary of tofacitinib from two phase I, nine phase II, six phase III and two long-term extension studies in adult patients with active RA.</p>
</sec>
<sec><title>Methods</title>
<p>Data were pooled for all tofacitinib-treated patients (data cut-off: 31 March 2015). Incidence rates (IRs; patients with event/100 patient-years) and 95% CIs are reported for adverse events (AEs) of interest.</p>
</sec>
<sec><title>Results</title>
<p>6194 patients received tofacitinib for a total 19 406 patient-years' exposure; median exposure was 3.4 patient-years. IR (95% CI) for serious AEs was 9.4 (9.0 to 9.9); IR for serious infections was 2.7 (2.5 to 3.0). IR for (all) herpes zoster was 3.9 (3.6 to 4.2); IR for disseminated or multidermatomal herpes zoster was 0.3 (0.2 to 0.4). IR for opportunistic infections (excluding tuberculosis) was 0.3 (0.2 to 0.4) and was 0.2 (0.1 to 0.3) for tuberculosis. IR for malignancies (excluding non-melanoma skin cancer (NMSC)) was 0.9 (0.8 to 1.0); NMSC IR was 0.6 (0.5 to 0.7). IR for gastrointestinal perforations was 0.1 (0.1 to 0.2). Analysis of IR for serious infections, herpes zoster and malignancies by 6-month intervals did not reveal any notable increase in IR with longer-duration tofacitinib exposure.</p>
</sec>
<sec><title>Conclusion</title>
<p>This analysis of tofacitinib exposure up to 8.5 years allowed estimation of safety events with improved precision versus previous tofacitinib reports. AEs were generally stable over time; no new safety signals were observed compared with previous tofacitinib reports.</p>
</sec>
<sec><title>Trial registration numbers</title>
<p><ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/study/NCT01262118?term=NCT01262118&rank=1">NCT01262118</ext-link>
, <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/study/NCT01484561?term=NCT01484561&rank=1">NCT01484561</ext-link>
, <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT00147498?term=NCT00147498&rank=1">NCT00147498</ext-link>
, <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/study/NCT00413660?term=NCT00413660&rank=1">NCT00413660</ext-link>
, <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT00550446?term=NCT00550446&rank=1">NCT00550446</ext-link>
, <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT00603512?term=NCT00603512&rank=1">NCT00603512</ext-link>
, <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT00687193?term=NCT00687193&rank=1">NCT00687193</ext-link>
, <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT01164579?term=NCT01164579&rank=1">NCT01164579</ext-link>
, <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT00976599?term=NCT00976599&rank=1">NCT00976599</ext-link>
, <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT01059864?term=NCT01059864&rank=1">NCT01059864</ext-link>
, <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT01359150?term=NCT01359150&rank=1">NCT01359150</ext-link>
, <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT00960440?term=NCT00960440&rank=1">NCT00960440</ext-link>
, <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT00847613?term=NCT00847613&rank=1">NCT00847613</ext-link>
, <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT00814307?term=NCT00814307&rank=1">NCT00814307</ext-link>
, <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT00856544?term=NCT00856544&rank=1">NCT00856544</ext-link>
, <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/results/NCT00853385?term=NCT00853385&rank=1">NCT00853385</ext-link>
, <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT01039688?term=NCT01039688&rank=1">NCT01039688</ext-link>
, <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT00413699?term=NCT00413699&rank=1">NCT00413699</ext-link>
, <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/study/NCT00661661?term=NCT00661661&rank=1">NCT00661661</ext-link>
; Results.</p>
</sec>
</div>
</front>
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