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Abstract Number: 1651

A Case Series on Patients on Tofacitinib in Combination with a Biologic

Nashla Barroso1 and Daniel E. Furst2, 1Rheumatology, UCLA David Geffen School of Medicine, Los Angeles, CA, 2David Geffen School of Medicine at UCLA, Los Angeles, CA

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: Biologics, Case Report, Psoriatic arthritis, rheumatoid arthritis, treatment and tofacitinib

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Session Information

Date: Monday, November 14, 2016

Session Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy - Poster II

Session Type: ACR Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose: Although there have been significant advances in the treatment of rheumatoid arthritis (RA) and psoriatic arthritis (PsA). patients can experience a lack of or loss of efficacy over time, requiring additions/switching among drugs. Tofacitinib is a highly targeted DMARD but it is not approved for use with biologics. and there has been concern about using tofacitinib in combination with biologics, particularly regarding the toxicity of these combinations. In this small case series, we report 6 patients on tofacitinib and various biologics as an initial documentation of the use tofacitinib and biologics in combination.

Methods: Clinical data of five RA patients and one PsA patient was extracted retrospectively from time prior to starting tofacitinib/biologic combination therapy until completion of 6-28 months of combination treatment. Data extracted included patient demographics, disease characteristics, significant comorbidities, previous and concomitant medications, adverse events (AEs) and serious adverse events (SAEs), laboratory data and clinical disease activity index (CDAI). Data was compared pre and post initiation of combo therapy. Relationship of AEs and SAEs to the combo was assessed based on known potential side effects of tofacitinib and the biologics.

Results: All RA patients fulfilled the 1987 American College of Rheumatology (ACR) classification and the PsA patient fulfilled the ClASsification criteria for Psoriatic ARthritis (CASPAR) All had moderate to severe disease(Table) 3 RA patients on tofacitinib in combination with tocilizumab, 1 with rituximab and 1 with etanercept, and 1 PsA patient on tofacitinib plus tocilizumab experienced no serious AEs and no deaths over 6-28 months (mean: 14 months) infections (67%), GI (67%), and hyperlipidemia (33%) occurred. 2 pts stopped tofacitinib secondary to AE’s (table). CDAI at the last report was essentially unchanged (20.9 vs 22.8 table)

Conclusion: In a small case series, there were no deaths nor serious AEs observed when patients used tofacitinib in combination with a biologic for a 6-28 months. This preliminary data indicates that further investigation of such combinations may be justified. Table 1

Demographics

RA

(n=5)

PsA

(n=1)

TOTAL

(n=6)

Female (%)

100

100

100

Age (mean years/range)

57.6/41-70

51

56.5/41-70

Seropositivity (%)

100

0

83

Erosive disease (%)

80

100

83

Disease duration (mean years/range)

25.8/6-32

9

18.5/6-32

Patients on background DMARDs (n)

4

1

5

Patients on prednisone (n)

3

1

4

Toxicity

SAEs

0

0

0

AEs

Infection

3

1

4

GI

3

1

4

Hematologic

1

0

1

Neurological

1

1

2

Lipids

2

0

2

Muskuloskeletal

1

0

1

Other*

3

1

4

AE resulting in D/C or interruption

3

0

3

SAE

0

0

0

AE

PT #4, #5 (2 AEs)

D/C due to lack of efficacy (n)

Pt #

1

Deaths

0

0

0

Efficacy

Mean months duration on combo (range)

12 (6-28)

4

10.7

Mean CDAI (range)

At start of combo

21.9 (14-27.5)

16

20.91 (14-27.5)

At end of combo/last visit

23.1 (12.5-41)

21.5

22.8 (12.5-41)

GI = gastroenterological; CNS = central nervous system; D/C = discontinuation; * nocturia, worsening of hyperglycemia, light headedness, nightly cramps, rash, worsening of depression


Disclosure: N. Barroso, None; D. E. Furst, None.

To cite this abstract in AMA style:

Barroso N, Furst DE. A Case Series on Patients on Tofacitinib in Combination with a Biologic [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/a-case-series-on-patients-on-tofacitinib-in-combination-with-a-biologic/. Accessed March 28, 2023.
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