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Abstract Number: 1340

Type and Frequency of Immune-Related Adverse Reactions in Patients Treated with Pembrolizumab (Keytruda), a Monoclonal Antibody Directed Against PD-1, in Advanced Melanoma at a Single Institution

Olga Pinkston1, Florentina Berianu1 and Benjamin Wang2, 1Rheumatology, Mayo Clinic, Jacksonville, FL, 2Division of Rheumatology, Mayo Clinic, Jacksonville, FL

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: Cancer treatments, Drug toxicity, immune response and vasculitis, PD-1

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Session Information

Date: Monday, November 14, 2016

Session Title: Miscellaneous Rheumatic and Inflammatory Diseases - Poster II

Session Type: ACR Poster Session B

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

Background/Purpose: Although immune checkpoint inhibitors improve survival in patients with melanoma and other cancers, the alterations to the immune system induced by these medications can trigger immune-related adverse reactions.  Documented immune-related adverse reactions of pembrolizumab include pneumonitis, immune-mediated colitis, hepatitis, endocrinopathies, and nephritis.  The purpose of this abstract is to identify the type and frequency of immune-related adverse reactions in patients treated with pembrolizumab at our institution.

Methods: We conducted a retrospective chart review of 74 patients who received pembrolizumab therapy to treat melanoma at our institution between September 2014 and May 2016.  The notes from the patients’ initial oncologic evaluations and all subsequent follow-up visit notes during their treatments with pembrolizumab were evaluated.  We focused on patient complaints, symptoms, physical exam results, and treatment plans.  Referrals to subspecialists and hospitalization records were also reviewed if applicable and available. Complaints and adverse reactions were grouped by organ system for detailed analysis. Treatment with glucocorticoids was also recorded.

Results: Seventy-four charts were reviewed, and 69 patients had advanced melanoma and were treated with at least 1 cycle of pembrolizumab. Please refer to the table below for the type and frequency of identified immune-related adverse reactions.  Rheumatology was consulted on 3 patients. One patient with a history of Raynaud’s disease was evaluated for hand pain with swelling. This patient was treated with prednisone prior to evaluation, which effectively treated the pain, but there was still residual, diffuse swelling of the hands and limited extension of the wrists bilaterally, but no synovitis was identified.  This patient had elevated ANA 1.1 and anti-histone antibody 1.1. Another patient had recurrent episodes of diarrhea and abdominal pain that required admission to the hospital for large-vessel vasculitis after a computed tomography scan showed thickening of the abdominal aorta and ileum as well as ileal dilation that was suggestive of ischemia due to vasculitis of the superior mesenteric artery.  Finally, one patient had history of seronegative rheumatoid arthritis who was in remission and no longer taking hydroxychloroquine and had no flare ups during pembrolizumab treatment.

Conclusion: We found that the incidence of significant adverse events was higher than reported in the populations treated with pembrolizumab, including a never-reported case of large-vessel vasculitis. Table 1: Selected Adverse Immune-Reactions Occurring in Patients Treated with Pembrolizumab

Total Patients with Advanced Melanoma 69
Female 27 39%
Males 42 61%
Age 25-45 5 7%
Age 51-59 10 14%
Age 60-69 20 29%
Age 70-79 24 35%
Age 80-87 10 14%
Mean Age 67
Adverse Reaction  All Grades # (%) Grade 3-4 # (%)
Musculoskeletal and Connective Tissue Disorders (Total 34 patients)
Arthralgia 28 (82%) 0 (0%)
Back pain 7 (21%) 0 (0%)
Hand/wrist pain 4 (12%) 0 (0%)
Synovitis 0 (0%) 0 (0%)
Large Vessel Vasculitis 1 (3%) 1 (3%)
Treated with glucocorticoids 11 (32%) 1 (3%)
Rheumatology consulted 3 (9%) 1 (3%)
History of CTD (rheumatoid arthritis) 1 (3%)

Total

34 (49%)
Skin and Subcutaneous Tissue Disorders (Total 26 patients)
Rash 19 (73%) 1 (4%)
Vitiligo 2 (8%) 0 (0%)
Pruritus 22 (85%) 0 (0%)
Lichenoid eruption 1 (4%) 0 (0%)
New onset psoriasis 1 (4%) 0 (0%)
Furunculosis a/w steroid induced acne 1 (4%) 0 (0%)
Treated with glucocorticoids 5 (19%) 1 (4%)

Total

26 (38%)
Gastrointestinal Disorders (Total 25 patients)
Diarrhea 12 (48%) 2 (8%)
Abdominal pain 6 (24%) 0 (0%)
Transaminitis 7 (28%) 2 (8%)
Immune mediated colitis 1 (4%) 1 (4%)
Treated with glucocorticoids 9 (36%) 4 (16%)

Total

25 (36%)
Endocrine Disorders (Total 13 patients)
Hypothyroidism 12 (92%)
Hypophysitis 1 (8%)

Total

13 (19%)

Disclosure: O. Pinkston, None; F. Berianu, None; B. Wang, None.

To cite this abstract in AMA style:

Pinkston O, Berianu F, Wang B. Type and Frequency of Immune-Related Adverse Reactions in Patients Treated with Pembrolizumab (Keytruda), a Monoclonal Antibody Directed Against PD-1, in Advanced Melanoma at a Single Institution [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/type-and-frequency-of-immune-related-adverse-reactions-in-patients-treated-with-pembrolizumab-keytruda-a-monoclonal-antibody-directed-against-pd-1-in-advanced-melanoma-at-a-single-institution/. Accessed February 2, 2023.
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